[Federal Register Volume 77, Number 132 (Tuesday, July 10, 2012)]
[Proposed Rules]
[Pages 40736-40778]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-16621]



[[Page 40735]]

Vol. 77

Tuesday,

No. 132

July 10, 2012

Part III





Department of Health and Human Services





-----------------------------------------------------------------------





Food and Drug Administration





-----------------------------------------------------------------------





21 CFR Parts 16, 801, 803, et al.





Unique Device Identification System; Proposed Rule

  Federal Register / Vol. 77 , No. 132 / Tuesday, July 10, 2012 / 
Proposed Rules  

[[Page 40736]]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 16, 801, 803, 806, 810, 814, 820, 821, 822, and 830

[Docket No. FDA-2011-N-0090]
RIN 0910-AG31


Unique Device Identification System

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is proposing to 
establish a unique device identification system to implement the 
requirement added to the Federal Food, Drug, and Cosmetic Act (FD&C 
Act) by section 226 of the Food and Drug Administration Amendments Act 
of 2007 (FDAAA), Section 226 of FDAAA amended the FD&C Act to add new 
section 519(f), which directs FDA to promulgate regulations 
establishing a unique device identification system for medical devices. 
The system established by this rule would require the label of medical 
devices and device packages to include a unique device identifier 
(UDI), except where the rule provides for alternative placement of the 
UDI or provides an exception for a particular device or type of device 
such as devices sold over-the-counter and low risk devices. Each UDI 
would have to be provided in a plain-text version and in a form that 
uses automatic identification and data capture (AIDC) technology. The 
UDI would also be required to be directly marked on the device itself 
for certain categories of devices for which the labeling requirement 
may not be sufficient, for example, those that remain in use for an 
extended period of time and devices that are likely to become separated 
from their labeling. The rule would require the submission of 
information concerning each device to a database that FDA intends to 
make public, to ensure that the UDI can be used to adequately identify 
the device through its distribution and use.

DATES: Submit either electronic or written comments on the proposed 
rule by November 7, 2012. Submit comments on information collection 
issues under the Paperwork Reduction Act of 1995 by September 10, 2012, 
(see section V, the ``Information Collection Requirements'' section of 
this document). See section VII for the proposed effective date of a 
final rule based on this proposed rule.

ADDRESSES: You may submit comments, identified by Docket No. FDA-2011-
N-0090 and/or RIN No. 0910-AG31, by any of the following methods, 
except that comments on information collection issues under the 
Paperwork Reduction Act of 1995 (see the ``Information Collection 
Requirements'' section of this document) must be submitted to the 
Office of Regulatory Affairs, Office of Management and Budget (OMB) at 
FAX: 202-395-7285, or email comments to [email protected]. 
Please mark your comments to the attention of the FDA desk officer and 
reference this rule.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments.

Written Submissions

    Submit written submissions in the following ways:
     Fax: 301-827-6870.
     Mail/Hand delivery/Courier [For paper or CD-ROM 
submissions]: Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
    Instructions: All submissions received must include the Agency 
name, Docket No., and Regulatory Information Number (RIN) for this 
rulemaking. All comments received may be posted without change to 
http://www.regulations.gov, including any personal information 
provided. For additional information on submitting comments, see the 
``Comments'' heading of the SUPPLEMENTARY INFORMATION section of this 
document
    Docket: For access to the docket to read background documents or 
comments received, go to http://www.regulations.gov and insert the 
docket number, found in brackets in the heading of this document, into 
the ``Search'' box and follow the prompts and/or go to the Division of 
Dockets Management, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Jay Crowley, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Avenue, Silver Spring, MD 20993, 301-796-5995, email: 
[email protected].

SUPPLEMENTARY INFORMATION:

Executive Summary

Purpose of the Regulatory Action

    This rule is intended to substantially reduce existing obstacles to 
the adequate identification of medical devices used in the United 
States. By making it possible to rapidly and definitively identify a 
device and key attributes that affect its safe and effective use, the 
rule would reduce medical errors that result from misidentification of 
a device or confusion concerning its appropriate use. The 
identification system established under this rule would lead to more 
accurate reporting of adverse events by making it easier to identify 
the device prior to submitting a report. It would allow FDA, healthcare 
providers, and industry to more rapidly extract useful information from 
adverse event reports, pinpoint the particular device at issue and 
thereby gain a better understanding of the underlying problems, and 
take appropriate, better-focused, corrective action. The rule will also 
require dates on medical device labels to conform to a standard format 
to ensure those dates are unambiguous and clearly understood by device 
users.
    The rule will fulfill the statutory requirement of section 519(f) 
of the FD&C Act (21 U.S.C. 360i(f)), which directs FDA to promulgate 
regulations establishing a unique device identification system for 
medical devices; this requirement was added to the FD&C Act by section 
226 of the Food and Drug Administration Amendments Act of 2007 (FDAAA), 
Public Law 110-85.
    In developing the proposed rule, FDA has been partnering with 
industry to conduct pilot tests to identify potential issues and 
generate feedback on the development of a UDI system. Throughout the 
pilot activities, labeler organizations from the medical device 
industry focused on identifying and understanding potential issues that 
would arise for labelers in implementing UDI and provided that feedback 
to FDA. The proposed rule reflects this industry input and the lessons 
learned from these pilot activities. FDA also solicited input through 
public meetings; a public workshop with stakeholders from the medical 
device industry, hospitals, payors and other stakeholders; and, a 
public request for information on a series of key questions related to 
the development of UDIs through which FDA received extensive input from 
the medical device industry and the broader healthcare community. FDA 
solicits comments on the proposed rule from all interested 
stakeholders, and is particularly interested in industry comment on 
whether the proposed approach reflects the lessons from the pilot 
activities.
    Under the proposed system, the health care community and the public 
would be able to identify a device

[[Page 40737]]

through a UDI that will appear on the label and package of a device. 
The UDI will provide a key to obtain critical information from a new 
database, the Global Unique Device Identification Database (GUDID), 
which will include information important to the identification of 
devices. UDIs will appear in both plain-text format and a format that 
can be read by a bar code scanner or some other AIDC technology. 
Certain devices for which the labeling requirement alone may not be 
sufficient would also be directly marked with a UDI, allowing accurate 
identification even when the device is no longer accompanied by its 
label or package. The types of devices that would be subject to the 
direct marking require are implantable devices; devices intended to be 
used more than once, and which are intended to be sterilized before 
each use; and stand-alone software. These types of devices have 
physical characteristics, or characteristics of use, that significantly 
increases the probability that the device will become separated from 
its label, particularly when used over an extended period of time.
    By ensuring the adequate identification of medical devices through 
distribution and use, the rule would serve several important public 
health objectives--
    Reduce Medical Errors. The presence of a UDI that is linked to 
device information in the GUDID database will facilitate rapid and 
accurate identification of a device, thereby removing a cause of 
confusion that can lead to inappropriate use of a device (e.g., 
confusion as to whether a device is packaged as sterile, or failure to 
recognize that a device is the subject of a recall or enforcement 
action). Using a device's UDI, you will be able to use the GUDID to 
positively identify the device and obtain important descriptive 
information, preventing confusion with any similar device which might 
lead to misuse of the device. Health care providers will no longer have 
to access multiple, inconsistent, and potentially incomplete sources in 
an attempt to identify a device, its key attributes, and a designated 
source for additional information.
    Simplify the Integration of Device Use Information Into Data 
Systems. UDIs, particularly when provided through AIDC technology, 
would allow rapid and accurate data acquisition, recording, and 
retrieval. The use of UDIs in computerized physician order entry 
systems will help ensure that the intended device will be used in the 
treatment of a patient, rather than some similar device that may not 
fully meet the requirements of the health care professional who ordered 
the use of the device.
    Provide for More Rapid Identification of Medical Devices With 
Adverse Events. An essential prerequisite to resolving adverse events 
is the timely and precise identification of the particular device or 
devices that may have a connection with an adverse event. The inclusion 
of UDIs in adverse event reports would lead to greater accuracy in 
reporting, by eliminating uncertainty concerning the identity of the 
device that is the subject of a report.
    Provide for More Rapid Development of Solutions to Reported 
Problems. The rule also would require the inclusion of UDIs in adverse 
event reports that are required under part 803. This would allow 
manufacturers and FDA to more rapidly review, aggregate, and analyze 
related reports regarding a particular device, leading to more rapid 
isolation and identification of the underlying problems, and 
development of an appropriate solution to a particular concern.
    Provide for More Rapid, More Efficient Resolution of Device 
Recalls. Delays in identifying recalled devices can result in the 
continued use of those devices on patients and involves an increased 
risk for patient harm. A device labeled with a UDI can be identified 
rapidly and with great precision and the UDI, particularly when 
combined with AIDC technology, will hasten the identification of 
devices that are the subject of a recall. The more rapidly a recall is 
implemented and completed, the more rapidly the risks presented are 
reduced and eliminated.
    Better-Focused and More Effective FDA Safety Communication. By 
citing UDIs, FDA would be able to more precisely focus safety alerts, 
public health notifications, or other communications, eliminating 
confusion with similar devices and allowing more rapid responsive 
action. Users of similar devices that are not the subject of the safety 
alert would be relieved of the uncertainty concerning whether they have 
been exposed to, or are affected by, a problem or risk.
    Provide an Easily-Accessible Source of Definitive Device 
Identification Information. While not required, inclusion of device 
identifiers in informational and educational materials, such as package 
inserts, training materials, educational materials, and other 
supplementary information, could provide a quick and useful means for 
patients and health care professionals to obtain additional information 
concerning a device, without having to provide that information in the 
document. This could allow the document to focus on its important core 
messages without the distraction of greater complexity, while a reader 
who wants those additional details could use the UDI to obtain 
information from the GUDID.
    Additional Benefits. FDA expects the UDI system will provide 
additional benefits. For example, UDIs could be used to enhance 
management of the Strategic National Stockpile, inventory management, 
and the provision of high-quality medical services. UDIs will 
facilitate the development of more useful electronic patient records by 
allowing providers to electronically capture and record important 
information concerning the use (including implantation) of a device on 
a patient. UDIs could help identify similar devices in the event of a 
shortage, and could help detect counterfeit devices.
    Standard Format for Dates Provided on a Device Label or Package. 
The rule would also contribute to improved identification of medical 
devices, and at the same time, better ensure the safe use of devices, 
by requiring dates on medical device labels to conform to a standard 
format--Month, Day, Year (e.g. JAN 1, 2012)--to ensure dates are 
unambiguous and clearly understood by device users.
Summary of the Major Provisions of the Regulatory Action in Question
    This rule would require the label of medical devices and device 
packages to include a UDI, except where the rule provides for 
alternative placement of the UDI or provides an exception for a 
particular device or type of device. Each UDI would have to be provided 
in a plain-text version and in a form that uses AIDC technology. The 
UDI would also be required to be directly marked on the device itself 
for certain categories of devices, such as those that remain in use for 
extended periods of time and are likely to become separated from their 
labeling. The rule would require the submission of information 
concerning each device to a database that FDA intends to make public, 
to ensure that the UDI can be used to adequately identify the device 
through its distribution and use. The FDA database would not include 
patient information. The rule would also require dates on device labels 
and packages to be presented in a standard format.
    The UDI system proposed by this rule builds on international 
regulatory cooperation activities and existing, internationally 
recognized standards relating to unique identification and data 
exchange. The rule would specify

[[Page 40738]]

the technical requirements of a UDI, which would consist of a portion 
that identifies the specific version or model of the device and the 
labeler of the device (the device identifier), and a portion that more 
precisely identifies the specific device by providing variable 
information, such as the lot or batch, the serial number, expiration 
date, or date of manufacture (the production identifier). Devices 
exempted from this proposed rule include devices, other than 
prescription devices, that are sold at retail establishments; this 
exception also applies to such a device when delivered directly to 
hospitals and other health care facilities. Also exempted are class I 
devices that FDA has by regulation exempted from the good manufacturing 
practice requirements of part 820 of this chapter. The production 
identifier would not be required for Class I devices. The proposed rule 
explains when a UDI is required and when its use must be discontinued. 
The rule would require all UDIs to be issued under a system operated by 
an FDA-accredited issuing agency. The rule would provide a process 
through which an applicant would seek FDA accreditation. The proposed 
rule specifies the information that the applicant would provide to FDA 
and the criteria FDA would apply in evaluating applications. The rule 
includes provision for the suspension or revocation of the 
accreditation of an issuing agency, and explains the circumstances 
under which FDA will, or may, act as an issuing agency.
    Whenever a device must bear a UDI, the labeler of that device would 
be required to submit information concerning the device to FDA to 
facilitate the rapid identification of the device and the labeler, and 
to provide links to other FDA data. FDA will make this information 
available to the public through a variety of channels, including a new 
database, the GUDID.
    The rule provides for appropriate exceptions and alternatives, 
ensuring that the costs and burdens are kept to a minimum.
    A final rule would become effective in stages, over a period of 
seven years, to ensure a smooth implementation and to spread the costs 
and burdens of implementation over time, rather than having to be 
absorbed all at once.
BILLING CODE 4160-01-P

[[Page 40739]]

[GRAPHIC] [TIFF OMITTED] TP10JY12.008

BILLING CODE 4160-01-C

Table of Contents

I. Background
    A. Objectives of the Proposed Rule
    1. Reduce Medical Errors
    2. Simplify the Integration of Device Use Information Into Data 
Systems
    3. Provide for More Rapid Identification of Medical Devices With 
Adverse Events
    4. Provide for More Rapid Development of Solutions to Reported 
Problems
    5. Provide for More Rapid, More Efficient Resolution of Device 
Recalls
    6. Better Focused and More Effective FDA Safety Communication

[[Page 40740]]

    7. Provide an Easily-Accessible Source of Definitive Device 
Identification Information
    8. Additional Benefits
    B. Certain Public Health Benefits of UDI Depend on the Adoption 
of IT Systems by Hospitals and Other Healthcare Facilities and on 
Statistical Methodologies to Interpret the Data Aggregated Using the 
UDI
    C. Principles That Guided Development of the Proposed Rule
    D. Prior Consultation With the Health Care Community and 
Industry
II. Description of the Proposed Rule
    A. Overview
    B. UDI Labeling Requirements (Part 801)
    1. Definitions
    2. When would the requirement for UDI labeling go into effect, 
and where would the UDI have to appear?
    3. How would UDI labeling requirements apply to a combination 
product and a device constituent part of a combination product?
    4. How would UDI labeling requirements apply to a convenience 
kit?
    5. Exceptions From, and Alternatives to, UDI Labeling 
Requirements
    6. May a device that is exempt from UDI labeling requirements 
nevertheless be labeled with a UDI?
    7. How would a UDI have to appear on a device label and on a 
device package?
    8. When would a device have to be directly marked with a UDI?
    9. After the requirement for UDI labeling goes into effect, may 
I continue to identify my device with the national health-related 
item code (NHRIC) or national drug code (NDC) number assigned to it?
    10. Formatting of Dates Provided on Medical Device Labels
    C. Requirements Relating to Issuing Agencies and Submission of 
Data to the Global Unique Device Identification Database (Part 830)
    1. Definitions
    2. What would be the requirements for the composition and 
issuance of a valid unique device identifier?
    3. Use and Discontinuation of a Device Identifier
    4. What changes would require a new device identifier?
    5. How would FDA accredit an issuing agency?
    6. What would be the responsibilities of an FDA-accredited 
issuing agency?
    7. How would an issuing agency relinquish its accreditation, and 
how would FDA suspend or revoke an issuing agency's accreditation?
    8. When would FDA act as an issuing agency?
    9. What devices would be subject to GUDID data submission 
requirements?
    10. Would FDA ever reject data submitted to the GUDID or remove 
data from the GUDID?
    11. What device identification data would I have to submit to 
the GUDID?
    12. How would I have to submit device identification data to the 
GUDID?
    13. When would I have to submit device identification data to 
the GUDID?
    14. Would I be permitted to submit information to the GUDID that 
is not required by FDA?
    15. What records would a labeler be required to maintain 
concerning its UDIs?
    16. Who would have access to the information I submit to the 
GUDID?
    D. Conforming Amendments
III. Legal Authority for the Proposed Rule
IV. Analysis of Impacts
    A. Summary of Costs
    1. Costs to Domestic Labelers
    2. Costs to Issuing Agencies
    3. Costs to FDA to Establish and Maintain the GUDID
    4. Cost to Foreign Labelers
    5. Uncertainty
    6. Alternatives
    B. Summary of Regulatory Flexibility Analysis
    C. Summary of Benefits
V. Information Collection Requirements
    A. Reporting Requirements
    B. Recordkeeping Requirements
    C. Total Annual Cost Burden
VI. Environmental Impact
VII. Proposed Effective Date
VIII. Federalism
IX. Request for Comments
    A. Submission of Comments
    B. Specific Questions
X. References

I. Background

A. Objectives of the Proposed Rule

    This rule is intended to substantially reduce existing obstacles to 
the adequate identification of medical devices used in the United 
States. By providing the means to rapidly and definitively identify a 
device and key attributes that affect its safe and effective use, the 
rule would reduce medical errors that result from misidentification of 
a device or confusion concerning its appropriate use. The 
identification system established under this rule would lead to more 
accurate reporting of adverse events by making it easier to identify 
the particular device involved prior to submitting a report. It would 
also allow FDA, healthcare providers, and industry to more rapidly 
extract useful information from adverse event reports, pinpoint the 
particular device at issue and thereby gain a better understanding of 
the underlying problems, and take appropriate, narrowly-focused, 
corrective action.
    The rule will fulfill a statutory directive to establish a unique 
device identification system. Section 226 of FDAAA amended the FD&C Act 
to add new section 519(f), which directs FDA to promulgate regulations 
establishing a unique device identification system for medical devices: 
``Unique Device Identification System. The Secretary shall promulgate 
regulations establishing a unique device identification system for 
medical devices requiring the label of devices to bear a unique 
identifier, unless the Secretary requires an alternative placement or 
provides an exception for a particular device or type of device. The 
unique identifier shall adequately identify the device through 
distribution and use, and may include information on the lot or serial 
number.''
    Under the system that would be established by this proposed rule, 
two tools would be used together to identify a device: A UDI on the 
label and packaging of a device (represented both in plain text and 
through automatic identification and capture technology), and a new 
database, the GUDID, containing device identification information for 
each UDI. Certain devices, such as those that remain in use for 
extended periods of time and are likely to become separated from their 
labeling, would also be directly marked with a UDI, allowing accurate 
identification even when the device is no longer accompanied by its 
label or package. The principles behind the rule's requirements and 
exceptions regarding UDI labeling and the GUDID are discussed in more 
detail in section I.B of this document.
    By requiring adequate identification of medical devices through 
distribution and use, the rule would serve several important public 
health objectives--
1. Reduce Medical Errors
    Device-related medical errors are a serious problem. The presence 
of a UDI that is linked to identifying information in the GUDID 
database will facilitate rapid and accurate identification of a device, 
thereby removing a cause of confusion that can lead to inappropriate 
use of a device (e.g., confusing a sterile version or model with a 
version or model that is not sterile and which requires sterilization 
prior to use, or failing to recognize that a particular device is the 
subject of a recall or enforcement action). The presence of AIDC 
technology as part of a UDI would make it possible to ``scan'' a device 
at a patient's bedside and rapidly compare the device attributes 
reported to the GUDID with the medical order and the patient's history, 
thereby improving the accuracy of device use and providing greater 
assurance that a device is appropriate for the patient.
    Providing a single, authoritative source of information--the 
GUDID--to facilitate the unambiguous identification of medical devices 
used in the United States.
    The proposed system would allow anyone to use a device's UDI to 
look up identifying information in the GUDID

[[Page 40741]]

concerning the device, including: The FDA premarket submission number 
of the device; the proprietary, trade, or brand name of the device; any 
version or model number or similar reference; the Global Medical Device 
Nomenclature (GMDN) generic descriptor for the device; if the device is 
available in more than one size, the size of the particular version or 
model, together with the unit of measure; the total number of devices 
in the package; and an email address or telephone number for a contact 
who can provide additional information to FDA. Together, this 
information will permit positive identification of the device and 
prevent confusion with any similar device. Health care providers will 
no longer have to access multiple, inconsistent, and potentially 
incomplete sources in an attempt to identify a device, its key 
attributes, and a designated source for additional information.
    Ensuring the accurate identification of certain devices, even when 
the device is separated from its label and package.
    The rule would require some devices to be directly marked with a 
UDI, so that it will always be possible to positively identify the 
device, regardless of how long the device remains in use. These 
devices, by their intended or customary use, are typically separated 
from the labeling that accompanies delivery of the device to users:
     An implantable device;
     A device that is intended for more than one use and to be 
sterilized before each use; and
     Stand-alone software.
    These devices involve unique risks to patients, and consequently it 
is particularly important to ensure the adequate identification of such 
devices throughout the entire product life cycle. For example, a device 
that is intended for more than one use, but which must be sterilized 
before each use, might be used over several years; during that time, 
the device package, with its label and any package insert, might be 
lost, leaving the user of the device uncertain as to whether the device 
needs to be sterilized, or just given a routine cleaning, and if 
sterilization is required, what type of sterilization process should be 
employed. The same is true for implanted devices and stand-alone 
software--loss of the device package and accompanying labeling can 
leave the user uncertain as to how to use the device, how to monitor 
its performance, or what actions should be taken in particular 
circumstances.
    Providing rapid and continuous access to key information relating 
to the device.
    FDA intends to provide Internet access to all data in the GUDID. 
Furthermore, once data concerning a device has been submitted to the 
GUDID, it will remain available long after production and marketing of 
the device has ceased. The GUDID will include information important to 
the identification of the device, but will not include patient 
information.
2. Simplify the Integration of Device Use Information Into Data Systems
    UDIs, particularly when provided through AIDC technology, would 
allow rapid and accurate data acquisition, recording, and retrieval. 
The use of UDIs in patient records, particularly electronic patient 
records, would help avoid confusion among similar devices during an 
extended treatment period and where more than one health care provider 
is involved in the administration of a course of treatment. The use of 
UDIs in computerized physician order entry systems will help ensure 
that the intended device will be used in the treatment of a patient, 
rather than some similar device that may not fully meet the 
requirements of the health care professional who ordered the use of the 
device.
3. Provide for More Rapid Identification of Medical Devices With 
Adverse Events
    An essential prerequisite to resolving adverse events is the timely 
and precise identification of the particular device or devices that may 
have a connection with an adverse event. The proposed UDI system would 
make this possible. From 2005 through 2009, FDA received an average of 
more than 492,000 adverse event reports involving devices each year. 
During this 5-year period, more than 17,700 reports involved a death, 
and more than 283,000 reports involved an injury.
    Because reports come from multiple sources--manufacturers, device 
user facilities, importers, and voluntary reports from physicians and 
other concerned individuals--we often receive more than one report of a 
particular death or injury. Reviewing a significant number of reports, 
seeking essential missing information, and resolving inconsistencies 
among reports are major challenges, particularly when trying to 
identify recurring problems involving a particular device. Although we 
do not have precise statistics, many initial reports do not provide a 
precise identification of the specific device the report concerns and 
require extensive FDA follow-up to identify the specific device 
involved. The inclusion of UDIs in adverse event reports would lead to 
greater accuracy in reporting, and eliminate uncertainty concerning the 
identity of devices that are the subject of reports.
4. Provide for More Rapid Development of Solutions to Reported Problems
    The inclusion of UDIs in adverse event reports would allow 
manufacturers and FDA to more rapidly review and analyze reports and 
identify the particular device at issue. This would permit more rapid 
isolation and identification of the underlying problems, and 
development of an appropriate solution to a particular concern. UDIs 
would also allow FDA, manufacturers, and the healthcare community to 
more accurately target safety alerts, recalls, and other corrective 
actions on the specific devices that are of concern. UDIs, particularly 
when provided using AIDC technology, would allow device user facilities 
and health care professionals to identify those devices more rapidly 
and with greater assurance, and prevent further patient exposure. At 
the same time, devices not implicated by the problem would be less 
likely to be ``swept up'' in an over-broad attempt to remove 
potentially hazardous devices.
5. Provide for More Rapid, More Efficient Resolution of Device Recalls
    Currently, locating all devices subject to a recall is a time- and 
labor-intensive process. Manufacturers, distributors, and healthcare 
facilities often do not know how many recalled devices they have in 
stock, do not know exactly where those devices are located, and are 
sometimes uncertain which of several similar devices is the subject of 
a recall. Consequently, delays in identifying recalled devices can 
result in the continued use of those devices on patients in a variety 
of settings (e.g., hospitals, long-term care facilities, homecare 
environments) and involves an increased risk for patient harm. A device 
labeled with a UDI can be identified more rapidly and with greater 
precision than a device that does not bear a UDI. The use of AIDC 
technology, such as a bar code, would allow increased use of automation 
to speed efforts to identify specific devices that are the subject of a 
recall. The more rapidly a recall is implemented and completed, the 
more rapidly the risks presented are reduced and eliminated.
    A class 1 recall is the most serious type of recall, and involves a 
situation where there is a reasonable probability that use of the 
device will cause serious injury or death. It is particularly 
important, therefore, that a class 1 recall be completed as rapidly as 
possible. The absence of a system that allows rapid

[[Page 40742]]

and reliable identification of the particular devices that are being 
recalled means hospitals and health care professionals have to rely on 
a variety of identification systems and examine a variety of attributes 
to identify a recalled device. A class 1 recall may direct that a 
device be returned to the manufacturer for exchange or refund, be 
destroyed, or be subjected to some other corrective action, such as a 
software upgrade. Any confusion or lack of complete clarity in 
identifying the device will undermine the effectiveness of the recall. 
Therefore, each recall attempts to identify the device as precisely as 
possible, but the great variation in devices and the terms used to 
describe them can make it difficult to describe a device with complete 
clarity. Here are some of the descriptors manufacturers used to 
identify specific devices subject to class 1 recalls during 2008 and 
2009:

    Table 2--Examples of Descriptors Used To Identify Devices Subject to Class 1 Recalls During 2008 and 2009
----------------------------------------------------------------------------------------------------------------
                 Descriptor                              Example of a recall that used the descriptor
----------------------------------------------------------------------------------------------------------------
Catalog number..............................  Pointe Scientific, Inc., Liquid Glucose Hexokinase Reagent
                                               (October 19, 2009).
Lot number..................................  Covidien Pedi-Cap End-Tidal CO2 Detector (July 17, 2009).
Material Number.............................  Boston Scientific NexStent Monorail, NexStent Carotid Stent and
                                               Monorail Delivery System (June 6, 2008).
Model number................................  Baxter Colleague Single and Triple Channel Volumetric Infusion
                                               Pumps (January 23, 2009).
Part number.................................  Synthes USA, Ti Synex II Vertebral Body Replacement (September 14,
                                               2009).
``Product code''............................  Smiths Medical ASD, Inc., Portex Uncuffed Pediatric[dash]Sized
                                               Tracheal Tubes (August 25, 2009).
                                                 Note: The ``product code'' used here is a code developed by
                                                  Smiths Medical; it is not the product code used by FDA.
Product number..............................  Physio Control, Inc. LifePak CR Plus Automated External
                                               Defibrillators (August 29, 2008).
Serial number...............................  ZOLL Medical Corporation, ZOLL AED Plus Defibrillator (February
                                               12, 2009).
Universal Product Code (UPC)................  Luv N' Care Gel-Filled Teethers--``Nuby,'' ``Cottontails,'' and
                                               ``Playschool'' (July 17, 2009).
----------------------------------------------------------------------------------------------------------------

    Often, a recall must cite more than one descriptor to identify the 
specific devices subject to the recall. For example, a September 22, 
2009, class 1 recall of the Penumbra, Inc., Neuron 6F 070 Delivery 
Catheter required reference to both the product catalog number and the 
lot number to determine whether a particular catheter was subject to 
the recall, and a June 17, 2009, class 1 recall of Abbott Vascular-
Cardiac Therapies/Guidant Corp. POWERSAIL Coronary Dilatation Catheters 
referred to product designation, product number, lot number, and 
expiration date. Recalls would be expedited and simplified if a single 
descriptor, such as the proposed UDI, could serve to adequately 
identify all devices.
    There is no uniformity in the placement or formatting of the 
descriptors presently used to identify devices, and no assurance that 
different companies are using a given term in the same way. The 
inconsistency in methods used to identify a recalled device complicates 
efforts to identify such devices that remain in possession of a 
patient, physician, or in a hospital's inventory and to complete the 
remedial action that would mitigate or eliminate the risk of further 
harm. These problems would be significantly reduced by the presence of 
UDIs on the labels and packaging of devices and the inclusion of UDIs 
in recall notification information. The inclusion of AIDC technology, 
such as a bar code or a RFID tag, would permit inventories to be 
checked more rapidly and would result in the more accurate detection 
and removal of recalled devices.
6. Better-Focused and More Effective FDA Safety Communication
    By citing a device identifier, or a range of UDIs, FDA would be 
able to more precisely focus a safety alert, public health 
notification, or other communication on the particular device that is 
the subject of the alert, eliminating confusion with similar devices. 
Health care professionals and patients would be able to take responsive 
action more rapidly, and users of similar devices that are not the 
subject of the safety alert would not be faced with the uncertainty of 
not knowing whether they have been exposed to, or are affected by, a 
problem or risk.
7. Provide an Easily-Accessible Source of Definitive Device 
Identification Information
    While not required, inclusion of device identifiers in 
informational materials, such as package inserts, could provide a quick 
and useful means for patients and health care professionals to obtain 
additional information concerning a device, without having to provide 
that information in the document. This could allow the document to 
focus on its important core messages without the distraction of greater 
complexity, while a reader who wants those additional details could use 
the UDI to obtain information from the GUDID.
8. Additional Benefits
    FDA has concluded that a UDI system has the potential to provide 
additional benefits. For example, we expect UDIs could be used by other 
Federal agencies, such as the Centers for Medicare and Medicaid 
Services, the National Institutes of Health, the Centers for Disease 
Control and Prevention, the Department of Defense, the Department of 
Homeland Security, and the Department of Veterans Affairs, for a wide 
variety of purposes, ranging from management of the Strategic National 
Stockpile, inventory management, and the provision of high-quality 
medical services. Other benefits include facilitating the development 
of more useful electronic patient records by allowing providers to 
electronically capture and record important information concerning the 
use of a device on a patient. UDIs could help identify similar devices 
in the event of a shortage, and could reduce the potential for injury 
from counterfeit devices by offering a better way to detect a 
counterfeit product and remove it from the market.
    The UDI system would provide a basic infrastructural element, which 
would allow unambiguous identification of medical devices throughout 
their lifecycle and would provide the foundation for a host of 
benefits. These may include improved device traceability, improved 
postmarket surveillance, and better security of devices through more 
effective detection and removal of counterfeit devices, and other

[[Page 40743]]

improvements that support FDA's public health mission.
    Through our work with the Global Harmonization Task Force (GHTF) 
and foreign regulatory partners, we envision that the UDI system would 
support global public health initiatives with which FDA is concerned, 
including more efficient and effective cross-border identification of 
devices, adverse event reporting and postmarket surveillance, and would 
improve our ability to communicate and respond to issues and concerns 
about devices used not only in the United States, but in other nations 
as well.

B. Certain Public Health Benefits of UDI Depend on the Adoption of IT 
Systems by Hospitals and Other Healthcare Facilities and on Statistical 
Methodologies to Interpret the Data Aggregated Using the UDI

    The full benefits of UDI require that hospitals and other 
healthcare facilities concurrently adopt information technology (IT) to 
fully realize the enhanced ability to identify devices throughout 
distribution and use. In order to realize its full potential benefits, 
UDI users must be able to store UDI information in various 
administrative, clinical and payment information systems, including 
EHRs. Though many such systems exist today, changes will need to be 
made in the systems to accommodate UDI.
    The use of electronic health technology to reduce medical errors in 
healthcare facilities would require the use of scanners (many of which 
are already in place) and standard operating procedures for using newly 
developed systems that link critical patient information (such as latex 
sensitivity) with specific medical device information. Hospitals and 
other health-care facilities will choose to make investments in the new 
technology and methods if they expect it to be a cost-effective method 
to reduce errors and improve patient safety involving medical devices.
    Putting a standardized unique device identifier on a device label 
is one step in creating systems that could reduce device related 
medical errors. The proposed rule would create a platform that would 
enhance the value of the new electronic health technologies and thereby 
encourage their development. But the proposed rule does not require 
hospitals and other health care facilities to make these changes.

C. Principles That Guided Development of the Proposed Rule

    In developing our proposed system for identification of devices, 
FDA first developed several general objectives, or principles, that we 
then applied throughout the drafting of our proposed rule. Each of 
these principles is identified in this section I.B, with a brief 
discussion of how they are resolved in the proposed rule.
    The UDI system should generally include all classes of devices, 
with appropriate exceptions.
    The healthcare community needs to identify a wide range of medical 
devices in every medical specialty. When fully phased-in, the rule will 
apply to all three device classes; however, we are proposing to exempt 
class I devices from production identifiers and proposing full 
exceptions from UDI labeling and data reporting for certain very low 
risk devices and other categories of devices; see proposed Sec. Sec.  
801.30, 801.35, and 801.128(f). Although we are not aware of compelling 
reasons for other exemptions based on the device class or medical 
specialty, for example, we seek comments on this issue.
    The UDI system should be based on existing, broadly-accepted 
standards.
    Basing the UDI system on existing, accepted standards ensures that 
all UDIs will be unique, broadly compatible, and broadly accepted for 
use by the U.S. healthcare community and in international commerce. By 
incorporating these existing standards into our proposed system, we 
avoid the confusion, inconsistency, and inefficiency that would result 
if every labeler created their own device identifiers without regard 
for the needs of the healthcare community. Therefore, the UDI system we 
are proposing would incorporate by reference four international 
standards: International Organization for Standardization/International 
Electrotechnical Commission (ISO/IEC) 646:1991, Information 
technology--ISO 7-bit coded character set for information interchange; 
ISO/IEC 15459-4:2006(E), Information technology--Unique identifiers--
Part 2: Registration procedures; ISO/IEC 15459-4:2008, Information 
technology--Unique identifiers--Part 4: Individual items; and ISO/IEC 
15459-6:2007, Information technology--Part 6: Unique identifier for 
product groupings. See proposed Sec.  830.10. In addition, all widely-
used AIDC technologies--e.g., bar codes, RFID tags, and near-field 
communication are based on established, broadly-supported standards. 
(Ref. 1) A multiplicity of nonstandardized systems would impose 
excessive costs on device user facilities and others, would provide no 
assurance that identifiers would be unique, would run counter to 
efforts to achieve international harmonization with regard to the 
identification of devices, and would greatly complicate FDA efforts to 
identify and resolve adverse events and other problems involving 
devices.
    The UDI system should recognize that the private sector has already 
implemented device identification systems, and, where possible, the 
rule should not require significant alteration of those systems.
    FDA is aware of two existing device identification systems that are 
based on the ISO/IEC standards discussed in the preceding paragraph. 
The International not-for-profit association known as ``GS1'' operates 
a system that uses a Global Trade Identification Number (GTIN) to 
identify a device; GS1 also operates the Universal Product Code (UPC) 
system that is used to identify most items sold by retail 
establishments in the United States. (Ref. 2) The Health Industry 
Business Communications Council (HIBCC) operates a system that encodes 
an identifier in a Health Industry Bar Code (HIBC) to identify a 
device. (Ref. 3) We believe roughly 35 to 50 percent of all medical 
devices used in the United States are already labeled with device 
identifiers that conform to one of the systems operated by these two 
organizations (a 2005 ECRI Institute report, ``Automatic Identification 
of Medical Devices,'' cited survey data suggesting bar codes were 
currently found on 25 percent of class I devices, 44 percent of class 
II devices, and 50 percent of class III devices) (Ref. 4). These 
existing systems are providing valuable services to device user 
facilities (hospitals, nursing homes, and other facilities) and to 
health care professionals. These systems have proven to be successful 
in creating unique identifiers that are in widespread use in systems 
used by hospitals, healthcare professionals, and industry.
    Because these existing systems include tightly-integrated functions 
that go far beyond simply identifying devices--functions such as 
inventory management and enabling commercial transactions that are not 
part of FDA's public health responsibilities and are outside our 
statutory authority--FDA believes it would be inefficient and 
counterproductive to try to replace the existing systems with a single, 
FDA-designed system of device identifiers. Because any FDA system would 
necessarily have a narrow scope limited to the adequate identification 
of devices, labelers would have to continue to use the existing systems 
as well as the FDA system, which would result in duplication of effort, 
substantial

[[Page 40744]]

additional costs, and potentially confusing identification of devices 
that would undermine our public health objectives. Consequently, FDA's 
proposed UDI system will permit continued use of these existing 
systems, so long as the administering organizations apply for and 
obtain FDA accreditation, as discussed under question 5 of section II.C 
of this document. The GUDID will allow rapid access to key information 
concerning any device labeled with a UDI, regardless of the system used 
to assign the UDI.
    Burdens should be minimized.
    We have honed our proposed data submission requirements to minimize 
overlap and avoid inconsistency with other existing FDA regulatory 
requirements, such as establishment registration and device listing. We 
are proposing to require the submission of fewer types of data than 
those identified and discussed in the public meetings (Ref. 5) that 
influenced development of this proposed rule. See proposed Sec.  
830.310. We are requesting comments on whether we have adequately 
minimized overlap and inconsistency, and whether we should require or 
permit the submission of additional data that may be useful to the 
healthcare community.
    The UDI system should be open to technological advancements.
    The proposed rule would require each UDI to be provided in both a 
plain-text form and a form that uses AIDC technology. See proposed 
Sec.  801.45. FDA would not require use of any particular technology 
for the AIDC form of the UDI. The system would permit the use of any 
type of bar code, RFID tag, near-field communication, or any other 
technology, whether existing at the present time or developed in the 
future. This would allow for technological evolution and advancement 
without prior FDA approval. FDA expects that a new technology would be 
deployed only after considerable consultation among issuing agencies, 
device user facilities, healthcare professionals, and device 
manufacturers, and we believe such decisions are best left in the hands 
of the healthcare community.
    The UDI system should be designed to integrate smoothly with other 
FDA systems, such as registration and listing, postmarket surveillance, 
and adverse event reporting.
    We have taken care to avoid conflict and minimize overlap with 
existing regulatory requirements, and we have included several 
conforming amendments to existing regulatory requirements to ensure 
UDIs are integrated in our regulatory processes wherever appropriate 
and feasible. For example, Part 810--Medical Device Recall Authority, 
Part 820--Quality System Regulation and Part 821--Medical Device 
Tracking Requirements.
    Requirements should be phased in over several years to ensure 
smooth and effective implementation.
    Pursuant to the proposed tiered effective dates, UDI requirements 
would be phased in over seven years following publication of a final 
rule (see table 7 of this document). This would allow all 
participants--FDA, industry, the health care community, and other 
government agencies--ample time to become familiar with and phase-in 
the rule's labeling and data submission requirements. This approach 
also provides FDA the opportunity to identify unforeseen weaknesses or 
problems in our implementation of the UDI system and to make 
appropriate mid-course corrections within the scope and authority of 
this rule, if finalized. We are proposing to phase in the rule's 
requirements by class because this will allow us to focus first on 
devices that have higher risks.
    The UDI system should foster innovation by, and competition among, 
issuing agencies.
    The proposed rule would allow for accreditation of multiple issuing 
agencies, see proposed Sec.  830.100, so that the varying needs of 
labelers and users of different types of devices can be met by 
different systems with differing levels of complexity and function. 
Because all issuing agencies would have to employ systems based on the 
same technical standards, and would have to meet the same accreditation 
requirements, each system would still be broadly compatible with other 
systems. Furthermore, all systems would employ the FDA-administered 
GUDID database, which would serve as the single authoritative source of 
information for the positive identification of any device labeled with 
a UDI. We will maintain a list of all FDA-accredited issuing agencies 
on our Internet site.
    There will be effective FDA oversight of issuing agencies.
    Oversight is necessary to ensure that all device identifiers are 
unique and meet the proposed requirements, and that all system users 
are treated fairly. FDA is proposing to require that any organization 
that wishes to issue UDIs be accredited by FDA. See proposed Sec.  
830.20(a). We have included accreditation criteria and information 
submission requirements designed to ensure that only a well-qualified 
organization that would issue identifiers that comply with the proposed 
rule would be permitted to serve as an issuing agency. See proposed 
Sec. Sec.  830.100 and 830.110.
    The UDI system should provide for appropriate regulatory 
flexibility, including exceptions and alternatives.
    Where possible, we have included reasonable flexibility in our 
proposal. For example, certain categories of devices would be excepted 
from UDI requirements, see proposed Sec.  801.30, and labelers may 
request an exception or propose an alternative that would, for example, 
provide for more effective identification of a device, see proposed 
Sec.  801.35. Direct marking requirements would apply only to certain 
narrow categories of devices and there would be some flexibility in how 
this requirement may be satisfied, see proposed Sec.  801.50. We seek 
comment on whether these flexibilities achieve the appropriate balance.
    Safeguards should be provided to protect small businesses.
    We seek to do this in two ways. First, a business can choose to use 
any system provided by any accredited issuing agency, which will give 
the labeler a choice among a range of services at a range of fees. We 
anticipate that the participation of multiple issuing agencies will 
also lead to competition that will help ensure fees are reasonable. 
Second, FDA may act as an issuing agency if we find that a significant 
number of small businesses will be substantially harmed by the fees 
assessed by all accredited issuing agencies, see proposed Sec.  
830.200. If FDA acts as an issuing agency, any business would be 
permitted to use the FDA system and, under current law, there would be 
no fee, see proposed Sec.  830.210. We expect this provision will 
encourage issuing agencies to be sensitive and responsive to the needs 
of small businesses.
    The establishment of a publicly accessible GUDID database is a 
critical component of an effective UDI system.
    It is important to understand that a UDI is simply a numerical or 
alphanumerical code and on its face is not itself intended to 
communicate any information directly concerning a device; you would 
not, for example, be able to parse out a segment that indicates that 
the device is a cardiovascular device, or that the device is packaged 
sterile, or that the device is marketed under a particular FDA 
premarket submission. Instead, the UDI would function as a reference 
number allowing you to find data concerning the device in an FDA 
database, the GUDID. The real value of a UDI is derived from its 
connection to corresponding information identifying the version or

[[Page 40745]]

model of the device that bears the UDI, and an effective system of 
device identification requires both a UDI and a database to provide 
information concerning the particular version or model identified by 
that UDI. Our proposal would require the submission of information 
essential to the identification of a device, which would be provided 
freely and publicly through a single authoritative source, the GUDID.
    In order to serve the public health purposes discussed in section 
I.A of this document, the UDI system requires a GUDID that is freely 
and easily accessible to all--hospitals and other device user 
facilities, health care practitioners, patients, other government 
agencies, academia, industry, and the general public. None of the 
information that we are proposing to collect would constitute trade 
secret information, confidential commercial information, or personal 
privacy information, and public disclosure of this information would 
not be prohibited. Open access to the GUDID would also encourage the 
integration of UDI data into healthcare delivery support systems, 
electronic medical records, and procurement, inventory management, and 
accounting systems, and would allow those systems to work together more 
effectively and efficiently.

D. Prior Consultation With the Health Care Community and Industry

    In the Federal Register of February 26, 2004 (69 FR 9120), we 
published a final rule requiring bar codes on certain human drug and 
biological products to help reduce medication errors in hospitals and 
other health care settings. The bar code is intended to enable health 
care professionals to use bar code scanning equipment in conjunction 
with computerized medication administration systems to verify that the 
right drug, in the right dose, is being given to the right patient at 
the right time. This rule, now codified at 21 CFR 201.25 and 610.67, 
requires that manufacturers encode the unique National Drug Code (NDC) 
number in a linear bar code on the product's label. The bar code rule, 
however, does not apply to medical devices. In the preamble to the bar 
code rule, we stated that, unlike drugs, medical devices do not have a 
standardized, unique identifying system comparable to the NDC number, 
and that the absence of such a system complicates efforts to put bar 
codes on medical devices for purposes of preventing medical errors (69 
FR 9120 at 9132).
    Since the issuance of the final bar code rule, various entities 
have asked that we revisit the issue of bar coding for medical devices 
to improve patient safety, quality of care, and cost effectiveness of 
health care, e.g., by improving delivery and supply chain efficiency. 
In response to this, in 2005 FDA met with various stakeholders, 
including device manufacturers and distributors, hospital associations, 
and other Federal agencies to solicit information and comments about 
employing a uniform system for the unique identification of medical 
devices. As a result of these meetings, FDA believes the majority of 
stakeholders support the development of a uniform system of unique 
identifiers as a way to improve patient safety and recognize other 
ancillary benefits such as better management of the purchase, 
distribution, and use of medical devices. However, there were a variety 
of experiences and opinions about how best to implement such a system. 
In 2006, we commissioned a report from Eastern Research Group, Inc. 
(ERG), concerning the benefits, costs, and issues with developing and 
implementing a UDI System. (Ref. 6) Thereafter, we published a notice 
in the Federal Register of August 11, 2006 (71 FR 46233), requesting 
comments to help us understand how a unique device identification 
system could improve patient safety, for example, by reducing medical 
errors, facilitating device recalls, and improving medical device 
adverse event reporting.
    We used the comments responding to the August 2006 Federal Register 
notice to help develop the agenda and topics for a public meeting held 
on October 25, 2006. (Ref. 5) The information we received helped us 
move forward with development of a proposed rule, which was further 
spurred by enactment of FDAAA.
    FDA held a public workshop on February 12, 2009, to discuss issues 
relating to establishment of a UDI system (see 74 FR 2601, January 15, 
2009). (Ref. 5) We asked device identification standards organizations 
to discuss the development and use of UDI standards, including the use 
of production identifiers. We asked device manufacturers to discuss the 
use of standards and the marking of devices with UDIs. We also 
discussed the potential development and use of a UDI database in 
general and with respect to particular attributes, as well as issues 
relating to implementation of a UDI system by interested stakeholders 
(e.g., distributors, hospitals, payors). We asked device manufacturers 
to describe their current practices for applying standards to medical 
devices, including identifiers on medical device labels, and managing 
medical device identifier data. We also requested information regarding 
the difficulties and costs involved in adding a UDI to a device's 
label, including effects on manufacturing and labeling processes and 
expected capital and operating costs. We asked device user facilities 
(hospitals, nursing homes, and clinics) to describe how a UDI system 
could be used, the costs involved, whether a UDI system would require 
any change in operations, and how UDIs would affect adverse event 
reporting and recall management. We asked all interested persons to 
submit comments, including answers to any of these questions, to a 
regulatory docket, FDA-2008-N-0661, CDRH 200866--Unique Device 
Identification System; Public Workshop. Comments received by the docket 
may be reviewed at http://www.regulations.gov by searching for ``FDA-
2008-N-0661'' (enter this text in the search field following ``Enter 
Keyword or ID'').
    We carefully reviewed and considered all comments during our 
development of this proposed rule.

II. Description of the Proposed Rule

A. Overview

    The core requirements summarized here provide context for the more 
detailed discussions that follow:
     Proposed Sec.  801.18 provides for standardized formatting 
of dates on medical device labels, eliminating any possibility of 
confusion from date formats that might be interpreted in more than one 
way.
     The labeler of each device would be responsible for 
meeting labeling and data submission requirements under this proposal. 
The labeler would, in most instances, be the manufacturer of the 
device. The term ``labeler'' is defined at proposed Sec.  801.3, and is 
discussed in section II.B.1 of this document.
     Unless the device is excepted, the label of a medical 
device, and a device package, marketed in the United States would be 
required to bear a UDI; this requirement would be phased in over 5 
years. See proposed Sec.  801.20.
     The UDI would have to be provided in two forms: easily-
readable plain-text and AIDC technology. See proposed Sec.  801.45. 
These two forms ensure that the UDI of a device would be readily 
discernable to patients and health care professionals and to automated 
systems used to identify and manage devices.
     The proposed rule provides several categorical exceptions, 
proposed Sec.  801.30, as well as case-by-case

[[Page 40746]]

exceptions and alternatives, proposed Sec. Sec.  801.35 and 
801.128(f)(2).
     Direct marking would be required for certain categories of 
devices, with exceptions. For each device subject to direct marking, 
this requirement would go into effect two years after the base UDI 
labeling requirement goes into effect for that device. See proposed 
Sec.  801.50.
     Whenever a device must be labeled with a UDI, the labeler 
(the person who causes the label to be applied to the device) would 
have to submit data concerning that device to the GUDID database. See 
proposed Sec.  830.320. This information would have to be submitted no 
later than the date the label of the device must bear a UDI, and would 
have to be updated when changes occur. See proposed Sec.  830.330. 
Exceptions are identified in the detailed discussion of part 830. This 
data would be freely available to the public and would provide the 
information necessary to identify a device labeled with a UDI.
     UDI labeling requirements would also apply to--
    [cir] Certain combination products;
    [cir] In most instances, to the device constituent parts of 
combination products;
    [cir] Convenience kits; and
    [cir] A device included in a convenience kit, except for a single 
use device.
    The terms ``combination product'' and ``convenience kit'' are 
defined at proposed Sec.  801.3 and are discussed in section II.B.1 of 
this document.
     UDIs would be issued under systems operated by FDA-
accredited ``issuing agencies'' and conform to certain international 
standards, incorporated by reference at proposed Sec.  830.10. A 
different UDI would be required for each version or model of a device. 
These terms are defined at proposed Sec.  830.3.
     In order to provide for efficient implementation of this 
rule, we propose to phase in its requirements over several years. Table 
7 of this document, Effective Dates of UDI Regulatory Requirements, 
summarizes how we would phase in the requirements proposed in this 
rule.

B. UDI Labeling Requirements (Part 801)

    Part 801 (21 CFR part 801) provides FDA's general medical device 
labeling requirements. All devices are subject to subparts A through E 
of part 801, while subpart H provides special requirements for specific 
devices; subparts B, F, and G are presently reserved. FDA provides 
additional labeling requirements in subpart B of part 809 that apply 
only to in vitro diagnostic products. FDA is proposing amendments to 
part 801 to provide UDI labeling requirements for devices. The changes 
we are proposing to part 801 provide a new definitions section, see 
proposed Sec.  801.3; a new provision standardizing the format of dates 
provided on medical device labels, see proposed Sec.  801.18; new 
subpart B, Labeling Requirements for Unique Device Identification; and 
a proposed amendment to Sec.  801.128, regarding exceptions or 
alternatives to labeling requirements for medical devices held by the 
Strategic National Stockpile. Several definitions proposed for 
inclusion in part 801 would also be included in new part 830, Unique 
Device Identification. A proposed amendment to Sec.  801.119 (the 
labeling regulation specifically applicable to in vitro diagnostic 
devices) would make it clear that all UDI labeling requirements apply 
to such devices. In order to avoid confusion with regard to the use of 
National Health Related Item Codes (NHRICs) and NDC numbers currently 
used to identify some devices, proposed Sec.  801.57 would terminate 
the use of these legacy identifiers on the date the device must be 
labeled with a UDI; those dates are specified in proposed Sec.  
801.20(b).
1. Definitions
    The UDI regulation would not change the meaning of any term 
currently defined in Part 801. We are proposing, in new Sec.  801.3, 
several definitions relating to the use of UDIs on device labels. New 
Sec.  801.3 would not affect the existing definitions in part 801, and 
would not consolidate existing part 801 definitions into a single 
section. Each definition proposed in Sec.  801.3 is discussed in this 
section II.B.1.
    Automatic identification and data capture (AIDC) technology would 
be any technology that conveys the UDI or the device identifier of a 
device in a form that can be entered into an electronic patient record 
or other computer systems via an automated process. AIDC technologies 
most often use bar codes, RFID, or near field communication, but this 
rule does not specify the technologies that may be used and does not 
prohibit the use of any particular technology. We believe it is best to 
leave decisions concerning the selection and use of any particular AIDC 
technology to issuing agencies, the labeler, and the health care 
community in order to avoid unintentional interference with the 
development and adoption of new and improved AIDC technology.
    Center Director--This would be the Director of the Center for 
Devices and Radiological Health, or the Director of the Center for 
Biologics Evaluation and Research, depending on which Center has lead 
responsibility for a particular device.
    Combination product--Within the context of the UDI system, a 
combination product will involve at least one device and at least one 
drug or one biological product. The term is defined by 21 CFR 3.2(e), 
and would have the same meaning here. A combination product whose 
primary mode of action is that of a device is subject to UDI labeling 
requirements; see proposed Sec.  801.25(a). The constituent parts of a 
combination product would continue to be subject to all requirements 
that ordinarily apply to the particular type of product (device; drug; 
biologic), and this rule would require each device constituent part of 
a combination product to be labeled with its own UDI, regardless of 
whether the combination product is subject to UDI labeling. For 
example, the device constituent parts of a combination product whose 
primary mode of action is that of a drug would be subject to UDI 
labeling requirements; see proposed Sec. Sec.  801.25(b). However, a 
device constituent part of a combination product would not be required 
to have a UDI if it is physically, chemically, or otherwise combined 
with other constituents of the combination product in such a way that 
it is not possible for the device constituent part to be used except as 
part of the use of the combination product; see proposed Sec.  
801.30(a)(11). A drug-eluting stent is an example of a combination 
product where the device constituent part--the bare-metal stent--has 
been combined with a drug constituent in such a way that it is not 
possible for the stent to the used except as part of the combination 
product.
    Convenience kit--When two or more different types of medical 
devices are packaged together for the convenience of the user, the 
result is a convenience kit. A convenience kit would have to have a 
UDI; see proposed Sec.  801.25(c). Each device in a convenience kit 
would have to meet all FDA requirements that normally apply to a device 
of that type, including having its own UDI distinct from that of the 
convenience kit, except for single use devices included in a 
convenience kit; see proposed Sec.  801.25(d).
    Device package--This definition is intended to clarify which 
articles would be required to bear a UDI under proposed Sec.  
801.20(a)(2). It is also intended to clarify the scope of the term 
version or model, which includes this term in its definition 
(consistent with current business practice, a change to the quantity of 
devices in a device

[[Page 40747]]

package is one of the changes that results in a new version or model; 
see proposed Sec.  830.50 and related discussion under the heading 
``Version or model'' of this section II.B.1). Since these requirements 
would be consistent with current practices--the existing GS1 and HIBCC 
systems, and the standards that underlie both of those systems and the 
proposed FDA UDI system--they will be well-understood, there will be no 
need for multiple identifiers on device packages, and we will avoid any 
need for duplicative and inconsistent identification.
    This term would be defined as a package that contains a fixed 
quantity of devices. A package may be a box or any other type of 
container in which devices are distributed or sold, and would include 
packages within other packages. Unlike a shipping container, whose 
contents and quantity may vary between shipments, the quantity of a 
device package would remain constant. If you change the quantity in a 
device package, you will have created a new device package. FDA is 
proposing this definition because the existing GS1 and HIBCC systems, 
and the international standards that underlie those systems, all 
require differentiation among packages that contain different 
quantities of a device in order to facilitate inventory management, 
order processing, and other business purposes. The proposed UDI system 
needs to recognize and accommodate these existing business systems and 
practices to avoid creating requirements that would lead the healthcare 
community and industry to have to devise a supplementary system to 
implement the UDI system, which would unnecessarily impose added costs 
and burdens and potentially undermine the effectiveness of the UDI 
system if multiple types of identifiers were used. We invite comment on 
this understanding of current systems and the extent to which the 
proposed definition accommodates current practice. A change to a device 
package that does not make substantive changes to the information 
conveyed thereon or to the quantity in the package would not result in 
a new device package; for example, a change in graphics, fonts, colors, 
or formatting would not result in a new device package, but a change in 
quantity would result in a new device package.
    Finished device--This term is defined because it is used in the 
definition of lot or batch, which is discussed below. In turn, the 
definition of lot or batch is based on a definition in FDA's Quality 
System Regulation.
    Expiration date--This term is not defined in any other medical 
device regulation, but is in common use and an expiration date (or 
``use by'' date) is frequently provided on the labels of FDA-regulated 
products, including medical devices. The proposed definition is 
intended to capture the term's ordinary meaning, which we take to be 
the date by which the label of a device states the device must or 
should be used. We are defining the term because it is one of four 
production identifiers that, when provided on a device's label, would 
also have to be provided through a UDI (the other production 
identifiers are: The lot or batch of a device; the serial number of a 
device; and the date a device was manufactured); see the proposed 
definition of unique device identifier, which includes production 
identifier.
    FDA, we, or us would mean the Food and Drug Administration.
    Global Unique Device Identification Database (GUDID) would mean the 
FDA administered database that serves as a repository of information to 
facilitate the identification of medical devices through their 
distribution and use. This term would have the same definition in both 
parts 801 and 830; more information is provided later in this preamble, 
in the discussion of definitions used in part 830.
    Implantable device would mean a device that is intended to be 
placed in a surgically or naturally formed cavity of the human body. A 
device would be regarded as an implantable device only if it is 
intended to remain implanted continuously for a period of 30 days or 
more, unless the Commissioner determines otherwise in order to protect 
human health.
    Label would have the same meaning as is provided by section 201(k) 
of the FD&C Act.
    Labeler--This term would mean any person who causes a label to be 
applied to a device, or who causes the label to be modified, with the 
intent that the device will be introduced into interstate commerce 
without any subsequent replacement or modification of the label. In 
most instances, the labeler would be the device manufacturer, but the 
labeler may be a specification developer, a single-use device 
reprocessor, a convenience kit assembler, a repackager, or a relabeler. 
The labeler would be responsible for meeting the UDI labeling 
requirements proposed for inclusion in part 801.
    The addition of the name of, and contact information for, a person 
who distributes the device, without making any other changes to the 
label, would not be a modification for the purposes of determining 
whether a person is the labeler. If a modification to the label extends 
beyond this narrow latitude, the person who causes the modification to 
be made will be a labeler and will be subject to the requirements of 
this rule.
    The term labeler does not include a person who labels a device, or 
who modifies the label of a device, pursuant to the instructions of the 
person who actually places the device into interstate commerce. Thus, a 
contractor who labels a device, following the instructions of the 
specification developer or manufacturer, would not be the labeler. 
Instead, the person who ``causes'' the label to be applied or 
modified--the person who provided the labeling instructions, whose name 
is on the device, and who actually places the device into interstate 
commerce (FDA refers to such a person as a specification developer)--
would be the labeler and would be responsible for meeting UDI labeling 
requirements.
    Lot or batch--This definition is based on the definition used in 
the Quality System Regulation (QSR), Sec.  820.3(m), but deletes the 
QSR language concerning components and the condition ``whether or not 
it is packaged, labeled, or sterilized.'' This is because UDI 
requirements would not apply until the device is labeled, and 
sterilization would not be a factor in determining whether a device 
would have to bear a UDI (the need for sterilization prior to each use 
would be relevant in determining whether a device must be directly 
marked under proposed Sec.  801.50). Lot or batch is one of four 
production identifiers that, when provided on a device's label, must be 
provided through a UDI. See the proposed definition of unique device 
identifier.
    Shipping container--A shipping container would be a package, 
container, or pallet that is used for the shipment or transportation of 
devices from one point to another and whose contents may vary from one 
shipment to another. This rule would not require a UDI to be placed on 
any shipping container; see proposed Sec.  801.30(b).
    Specification--This definition is intended to clarify the scope of 
``specification'' as used in the definition of version or model. This 
definition builds on the definition of ``specification'' provided by 
the QSR, see Sec.  820.3(y), but uses ``device'' instead of ``product, 
process, service, or other activity,'' because the QSR has a wider 
scope.
    Unique device identifier (UDI)--The definition cites proposed Sec.  
830.20, which specifies the requirements for a valid UDI, and the 
statutory mandate of

[[Page 40748]]

the UDI system: To adequately identify a device through its 
distribution and use. A UDI may consist of two parts--
     A device identifier that identifies the specific version 
or model of a device and the labeler of that device; and
     A production identifier that identifies one or more of the 
following, when present on the label of the device:
    [cir] The lot or batch within which a device was manufactured;
    [cir] The serial number of a specific device;
    [cir] The expiration date of a specific device;
    [cir] The date a specific device was manufactured.
    The production identifier would not be required for class I 
devices; see Sec.  801.30(c). The device identifier would always have 
to be present in a UDI. The production identifier must be present 
whenever a lot or batch number, serial number, date of manufacture, or 
expiration date appears on the label of the device, except for class I 
devices. Because most device labels provide at least one of these 
identifiers, most UDIs would have to include a production identifier. 
This proposed rule would not itself require any production identifier 
to appear on a device label, but other FDA regulations and conditions 
of approval may require one or more to be provided on the label of a 
particular device or type of device, and many labelers already label 
their devices with one or more production identifiers.
    As discussed in section I.B of this document, the UDI is not 
structured to provide direct information concerning a device; the 
device identifier is a reference number that allows you to find data 
concerning the device in an FDA database, the GUDID. Whenever this 
proposed rule states that a UDI ``identifies'' a device, we are 
referring to the use of the UDI in conjunction with information 
concerning the device that the labeler of the device has submitted to 
the GUDID.
    Universal product code (UPC)--A universal product code is an 
identifier used to identify a company and product name for an item sold 
at retail in the United States. UPCs are based on the GS1 ``General 
Specification,'' an international standard.
    Version or model--This definition identifies the characteristics 
that make a device unique. Each version or model would be required to 
have its own device identifier, and when you add a new version or 
model, or make a change that results in a new version or model, that 
addition or change would require use of a new device identifier and 
would require you to submit information concerning the version or model 
to the GUDID. See proposed Sec. Sec.  830.50 and 830.330. The 
definition combines elements from definitions in the QSR for finished 
device and lot or batch, Sec. Sec.  820.3(l) and (m), and includes 
language to make clear that each distinct device package (each 
containing a different quantity of devices) would constitute a 
different version or model (and would therefore have its own device 
identifier).
2. When would the requirement for UDI labeling go into effect, and 
where would the UDI have to appear?
    Proposed Sec.  801.20(a) would require medical device labels and 
device packages to bear a UDI. Exceptions to this general rule are 
provided by proposed Sec. Sec.  801.30, 801.35, and 801.128(f)(2), and 
are discussed in section II.B.7 of this document.
    Thus, if a device is sold in individual device packages, which are 
sold in boxes of five device packages, which are sold in cartons that 
contain ten boxes of five device packages, a UDI would be required to 
appear on the individual device package, on the box of five packages 
(which is itself a ``device package,'' see proposed 801.3, because it 
contains a fixed number of devices), and on the carton of ten boxes of 
five device packages (again, because the carton is a ``device 
package''). This reflects existing practice within the health care 
community; both the existing GS1 and HIBCC systems, and the standards 
that underline those systems and the proposed FDA UDI system, follow 
this approach, and place an unique identifier on every distinct device 
package (Ref. 7).
    The presence of a UDI on each device package would improve the 
effectiveness and efficiency of recalls and other corrective actions 
targeting potentially harmful devices. For example, the presence of a 
UDI on outer packaging will enable distributors, hospitals, and others 
to enter it into their system upon receipt. Then they will know exactly 
what devices they have or had in their possession when, and if, there 
is a recall, tampering, counterfeiting, or other problems with the 
device at a later date, they can simply type in the applicable UDIs to 
determine whether they have (or had) the device in their possession. If 
there were no UDI on the outer packaging, the box or other type of 
container would need to be opened to access it, which could facilitate 
tampering and contribute to the very problems that the UDI system is 
designed to remedy.
    By requiring a UDI for device packages, the proposed UDI system 
strives for uniform identification of devices throughout their path of 
distribution and use. This will facilitate the unambiguous 
identification of devices wherever they are located and avoid the 
confusion that would be created by the use of multiple identifiers, and 
that would undermine the public health purposes of the rule. At 
present, most manufacturers generally follow this approach, and place 
an identifier on every device package (Ref. 7). If UDIs were not 
required to appear on all device packages, manufacturers would continue 
to use their existing identification systems, which would result in the 
use of multiple types of identifiers for a particular device. This 
would produce confusion and inhibit the rapid and precise 
identification of devices that is the goal of this rule. The fact that 
the proposed requirements are consistent with existing practices also 
lowers the burden of compliance.
    The requirement for device labels and device packages to bear a UDI 
would be phased in over several years:
     UDI labeling requirements will take effect for class III 
devices and devices licensed under the Public Health Service Act 
beginning 1 year after we publish a final rule; see proposed Sec.  
801.20(b)(1).
     UDI labeling requirements will take effect for class II 
devices beginning 3 years after we publish a final rule; see proposed 
Sec.  801.20(b)(2).
     UDI labeling requirements will take effect for class I 
devices and devices not classified into class I, II, or III beginning 5 
years after we publish a final rule; see proposed Sec.  801.20(b)(3) 
and (b)(4).
    See table 7 of this document for a summary of these and other 
effective dates proposed for this rule.
    Phasing in UDI labeling requirements over several years allows all 
parties--FDA, device labelers, hospitals and other device user 
facilities, and health care professionals--to prepare for, and 
implement, the requirements in an orderly, efficient manner. It also 
provides FDA the opportunity to clarify any confusion in implementation 
within the scope and authority of this rule, after it is finalized. We 
are proposing to phase in UDI labeling and data submission requirements 
by class because this will allow us to focus first on devices that have 
higher risks. Section 801.25 explains how these timeframes apply to 
convenience kits and combination products.
    The data reporting requirements of part 830 would go into effect at 
the same time as the UDI labeling requirements, see proposed Sec.  
830.330(a), using the same phased-in schedule as is set forth in 
proposed Sec.  801.20(b). These parallel

[[Page 40749]]

requirements--UDI labeling and data reporting--would go into effect 
together because, as discussed in section I.B of this document, the UDI 
would have limited value without the ability to look up information 
concerning the device in a database.
3. How would UDI labeling requirements apply to a combination product 
and a device constituent part of a combination product?
    Proposed Sec.  801.25(a) would require a UDI on the label and 
device package of every combination product whose primary mode of 
action is that of a device, regardless of which FDA Center has been 
designated as having primary jurisdiction for the premarket review and 
regulation of the product (in the great majority of cases where the 
combination product has a primary mode of action of a device, the lead 
Center will be the Center for Devices and Radiological Health). If FDA 
has determined that the primary mode of action of a combination product 
is not that of a device, we would not require a UDI on the label or 
package of the combination product. For a combination product with a 
primary mode of action other than that of a device, we envision that 
the combination product generally would be identified by an NDC (see 21 
CFR 201.25, 610.67; 71 FR 51276, August 29, 2006).
    Proposed Sec.  801.25(b) would require a UDI on the label and (when 
present) the device package of each device constituent part of a 
combination product, regardless of the primary mode of action of the 
combination product, which Center has the lead responsibility for the 
combination product, and whether the label and package of the 
combination product are required to bear a UDI, except where the device 
constituent part is physically, chemically, or otherwise combined with 
other constituents of the combination product in such a way that it is 
not possible for the device constituent part to be used except as part 
of the use of the combination product; see proposed Sec.  
801.30(a)(11). Thus, whenever it is possible for a device constituent 
part to be used separately from a combination product with a device 
primary mode of action, a UDI would be required to identify the 
combination product, and a different UDI would be required for each 
device constituent part that can be used separately from the use of the 
combination product. This approach is necessary both for the accurate 
identification of the product, and to facilitate effective recalls and 
adverse event reporting. For example, there may be a problem with a 
device constituent part of a drug-device combination product that 
applies only to the device when it is part of the combination product, 
or only to the device when used separately from the combination 
product. We seek comments on this approach to UDI applicability to 
combination products.
    With the exception of those products where it is not possible for 
the device constituent part to be used except as part of the 
combination product, the presence of either a UDI or an NDC on the 
label and package of combination products, and a UDI on the label and 
any device package of each device constituent part thereof, would 
assure precise identification.
4. How would UDI labeling requirements apply to a convenience kit?
    A convenience kit consists of two or more different types of 
medical devices packaged together for the convenience of the user. We 
propose to require a UDI on the label of and device package of each 
convenience kit. See proposed Sec.  801.25(c). We would also require 
each device in a convenience kit to bear its own UDI (a UDI distinct 
from that of the convenience kit) on its label and device package 
unless the included device is intended for a single use (e.g., an 
adhesive bandage). See proposed Sec.  801.25(d). The reason for 
requiring a UDI on the label and device package of each device in a 
convenience kit is that devices that are intended for more than a 
single use, such as surgical instruments that are sometimes packaged as 
parts of kits, often become separated from the convenience kit, and are 
used at some later time. Without a UDI, there is no assurance that the 
user will be able to adequately identify the device and be aware of 
relevant data in the GUDID database concerning that device. Because 
this potential problem is much less of a concern for a device intended 
for a single use, a single-use device included in a convenience kit 
would not need to bear a UDI; see proposed Sec.  801.30(a)(12). 
Inclusion in a convenience kit would have no effect on whether a device 
must be directly marked pursuant to proposed Sec.  801.50; if Sec.  
801.50 requires the device to be directly marked, the device must be 
directly marked regardless of whether it is included in a convenience 
kit.
5. Exceptions From, and Alternatives to, UDI Labeling Requirements
    The proposed rule would provide several exceptions to our UDI 
labeling requirements. The exceptions derive from statutory provisions 
or are designed to make the overall UDI system more efficient and to 
ensure that the burdens imposed by the UDI system are reasonably 
balanced with its benefits. A labeler that chooses for business or 
other reasons to voluntarily comply with any provision from which the 
labeler is excepted may, of course, do so.
    Proposed Sec.  801.30(a)(1) provides an exception for devices, 
other than prescription devices, that are sold at retail 
establishments, such as drug stores; this exception would also apply to 
such devices when sold directly to a hospital or other health care 
facility. A wide range of devices is available at retail, including 
automatic external defibrillators, insulin syringes, glucometers, 
tampons, thermometers, toothbrushes, bandages, and more. We are 
providing this exception to reduce the overall burden of the proposed 
rule, given that it is the prevailing industry practice to label such 
devices with a UPC, which may serve as an adequate substitute for 
devices sold over-the-counter at retail. For those labelers that choose 
to submit data to the GUDID on a voluntary basis, a UPC may serve as a 
UDI for devices sold at retail for purposes of submission of data to 
the GUDID; see proposed Sec.  830.300(c).
    Some devices sold over-the-counter at retail have been the subject 
of recalls and adverse events, and we would likely see significant 
benefits from participation in the UDI system. It is also possible that 
many other devices sold over-the-counter at retail would benefit from 
participating in the UDI system, and that those benefits would outweigh 
the costs of participation. Because of our uncertainty regarding the 
balance of interests regarding proposed Sec. Sec.  801.30(a)(1), FDA 
requests comments on the extent to which devices sold in retail 
establishments should be subject to the requirements of this proposed 
rule. Should these devices be excepted as provided by proposed 
Sec. Sec.  801.30(a)(1), or should they instead be subject to the 
proposed rule in the same manner and to the same extent as other 
devices?
    Proposed Sec.  801.30(a)(2) would except from UDI labeling 
requirements any class I device that FDA has by regulation exempted 
from the good manufacturing practice (GMP) requirements of part 820, 
the Quality Systems Regulation. If such a regulation requires that a 
class I device remain subject to Sec.  820.180, with respect to general 
requirements concerning records, or Sec.  820.198, with respect to 
complaint files, that device would nevertheless qualify for this 
exception.
    These are very simple devices, such as--
     Tuning fork (product code GWX)

[[Page 40750]]

     Elastic bandage (product code FQM)
     Examination gown (product code FME)
     Bedpan (product code FOB)
     Manual toothbrush (product code EFW)
    We have provided a list of the devices that at present would be 
eligible for this exception; see Ref 10. FDA is providing this list to 
illustrate the scope of this exception at the time of this proposed 
rule.
    Proposed Sec.  801.30(a)(3) provides an exception for individual 
class I, single-use devices, all of a single version or model, that are 
distributed together in a single package, whose uses are generally 
known to the persons by whom they are intended to be used, and which 
are not intended or promoted for individual sale. Those devices would 
not have to be individually labeled with a UDI. For example, this 
includes devices that are not individually wrapped (e.g., a box of 
patient examination gloves) and devices that are individually wrapped 
and bear identifying information, but which are not intended to be 
distributed individually (e.g., a box of adhesive bandages). In such 
cases, applying a UDI on each individual device would not be likely to 
contribute to better identification of the device and would be an 
unnecessary burden and cost. The device package containing these 
individual devices must, however, bear a UDI on its label.
    Proposed Sec.  801.30(a)(3) would apply only to class I devices 
because we believe that only class I devices are currently marketed in 
the manner contemplated by Sec.  801.30(a)(3). It is not our intent to 
require changes to current practices regarding the packaging of 
devices, and we are specifically seeking comment regarding this 
exception in question 15 of section IX of this document. Labelers of 
class II devices that would qualify for this exception but for their 
classification may request an exception or alternative under proposed 
Sec.  801.35.
    Proposed Sec.  801.30(a)(4) provides an exception for a device used 
solely for research, teaching, or chemical analysis, and not intended 
for any clinical use, as is consistent with FDA's general approach to 
the regulation of such articles as set out in 21 CFR 801.125.
    Proposed Sec.  801.30(a)(5) provides an exception for a custom 
device, or a device made to meet the unique needs of a patient or 
physician, within the meaning of Sec.  812.3(b). This exception is 
consistent with FD&C section 520(b), which provides that FD&C sections 
514, Performance Standards, and 515, Premarket Approval, do not apply 
to custom devices. Because a custom device is intended only for use by 
an individual patient and not generally available for sale, a UDI would 
not be necessary to uniquely identify the device.
    Proposed Sec.  801.30(a)(6) provides an exception for an 
investigational device within the meaning of part 812 (21 CFR part 
812). Investigational devices are subject to a variety of requirements 
under part 812 that ensure adequate identification of the device.
    Proposed Sec.  801.30(a)(7) provides an exception for a veterinary 
medical device not intended for use in the diagnosis of disease or 
other conditions in man, in the cure, mitigation, treatment, or 
prevention of disease in man, or intended to affect the structure or 
any function of the body of man.
    Proposed Sec.  801.30(a)(8) provides an exception for a device 
intended for export from the United States. This is because foreign 
nations have their own regulatory requirements, which may include 
identification requirements, with which the device must conform.
    Proposed Sec.  801.30(a)(9) provides an exception for a device held 
by the Strategic National Stockpile and granted an exception or 
alternative under Sec.  801.128(f)(2). This exception is consistent 
with other labeling exceptions that apply to devices held by the 
Strategic National Stockpile. For background on the Strategic National 
Stockpile, see FDA's Interim Final Rule concerning Exceptions or 
Alternatives to Labeling Requirements for Products Held by the 
Strategic National Stockpile (72 FR 73601, December 28, 2007).
    Proposed Sec.  801.30(a)(10) provides an exception for a device for 
which FDA has established a standard pursuant to section 514(b) of the 
FD&C Act and has provided therein an exception from the requirement of 
proposed Sec.  801.20, or for which FDA has recognized all or part of a 
standard pursuant to section 514(c) of the FD&C Act and has included an 
exception from the requirement of proposed Sec.  801.20 within the 
scope of that recognition. This exception is intended to provide FDA 
flexibility in the application of the UDI system, or an alternative, 
when we are using a standard as a special control for a particular 
device.
    Proposed Sec.  801.30(a)(11) provides an exception for a device 
constituent part of a combination product, provided that the device 
constituent part of a combination product is physically, chemically, or 
otherwise combined with other constituents of the combination product 
in such a way that it is not possible for the device constituent part 
to be used except as part of the use of the combination product. If it 
is possible for the device constituent part to be used in any way 
except as part of the use of the combination product, this exception 
does not apply. See discussion under preceding question 3.
    Proposed Sec.  801.30(a)(12) provides an exception for a device 
that is packaged in a convenience kit, provided that the device is 
intended for a single use. This exception does not apply if the device 
is intended for more than one use. See discussion under preceding 
question 4.
    Proposed Sec.  801.30(b) provides an exception for shipping 
containers, because they often contain different, unrelated devices, 
and sometimes other items as well. We do not propose to require a UDI 
be placed on any shipping container, but the device packages within the 
shipping container would be subject to all UDI labeling requirements 
unless an exception applies under proposed Sec. Sec.  801.30(a), 801.35 
or 801.128(f)(2).
    Proposed Sec.  801.30(c) provides an exception that would permit 
the labeler of a class I device to label it with a UDI that does not 
include any production identifiers; the UDI would only have to include 
the device identifier. Most Class I medical devices include a plain 
text version of relevant production identifiers (e.g., a lot number or 
an expiration date) somewhere on the device label. However, the cost of 
encoding production identifiers in dynamic barcodes for high-volume 
class I device production lines may outweigh the benefits of this 
enhanced identification. Furthermore, we believe that hospitals may be 
less likely to track or document individual class I device use in 
patient records, and are more likely to simply use a more-generic 
identifier; the device identifier portion of the UDI will adequately 
serve such needs. Labelers of class I devices are not prohibited from 
using a production identifier, but they would not be required to do so 
under this proposed rule.
    Proposed Sec.  801.35 authorizes additional, case-by-case, labeling 
exceptions beyond those provided by proposed Sec.  801.30; this section 
also authorizes alternatives to standard UDI labeling requirements. 
This provision is intended to ensure that the UDI system has adequate 
flexibility to accommodate any special circumstances regarding a 
particular device or type of device that indicate that application of 
the standard UDI labeling requirements is not technologically feasible 
or that the objectives of this rule would be better served by 
application of an alternative approach. Only a device labeler may 
request an exception or alternative

[[Page 40751]]

under proposed Sec.  801.35, although FDA may, under proposed Sec.  
801.35(d), provide an exception or alternative on our own initiative. A 
request for an exception or alternative under proposed Sec.  801.35 
would have to--
     Identify the device that would be subject to the exception 
or alternative;
     Identify the UDI labeling requirements that are the 
subject of the request for an exception or alternative;
     If requesting an exception, explain why the UDI labeling 
requirements are not technologically feasible;
     If requesting an alternative, describe it and explain how 
it would provide for more accurate, precise, or rapid device 
identification than the standard requirements or how the alternative 
would better ensure the safety or effectiveness of the device;
     Provide an estimate of the number of labelers and the 
number of devices that would be affected if we grant the requested 
exception or alternative.
    See proposed Sec.  801.35(a). We may request additional information 
needed to clarify the scope or effects of a request; see proposed Sec.  
801.35(a)(6).
    A request under proposed Sec.  801.35 could be submitted to FDA as 
part of a premarket submission, proposed Sec.  801.35(b), or through a 
written request at any time after a premarket submission has been 
filed, proposed Sec.  801.35(c). If we grant a request for an exception 
or alternative, we may include conditions to ensure the adequate 
identification of the device through its distribution and use, given 
the anticipated circumstances of use. If we grant an exception or 
alternative, we would provide information about the exception or 
alternative on our Internet site. If necessary to facilitate or 
implement an alternative granted under this section, FDA may, at our 
discretion, act as an issuing agency; see proposed Sec.  830.200(d).
6. May a device that is exempt from UDI labeling requirements 
nevertheless be labeled with a UDI?
    Yes. Proposed Sec.  801.40(a) permits the labeler of a device that 
is not required to bear a UDI to voluntarily include a UDI on the label 
of that device. We have included this provision because it may be in 
the interest of both labelers and their customers to use the same 
identification system for all devices, and not just those devices that 
this rule requires to bear a UDI. If the labeler voluntarily includes a 
UDI on the label of a device, the labeler may also voluntarily provide 
information concerning the device to the GUDID; see proposed Sec.  
830.300(c). We expect most labelers who voluntarily label their devices 
with UDIs will choose to voluntarily submit information to the GUDID in 
order to facilitate the identification of those devices.
7. How would a UDI have to appear on a device label and on a device 
package?
    We would require the UDI to be provided on the device label and 
each device package in an easily-readable, plain-text form. This is so 
patients, health care professionals, FDA, and other users of the UDI 
system would be able to read the UDI and enter it, at their discretion, 
into patient records, reports to FDA, and data systems without any 
technological assistance. We do not specify a particular font or point 
size for the UDI; rather, the UDI would be subject to existing 
requirements that govern medical device labels, including Sec.  801.15, 
concerning prominence of required label statements.
    The UDI would have to be provided on device labels and device 
packages through AIDC technology; see Sec.  801.45(a)(2). The AIDC 
version will facilitate efficient and accurate identification of the 
device, documentation of the use of the device in electronic records, 
and potentially many other uses, while reducing the possibility of 
human error. The AIDC technology may be a bar code, RFID, near-field 
communications (NFC), or any other technology that serves the same 
objectives. We do not specify what technologies may be used, because 
the most appropriate technology will vary considerably depending on the 
type of device and its intended uses, and because the available 
technologies are likely to evolve and advance over time.
    At present, we believe most device labelers would choose to meet 
the requirement for AIDC technology by providing a bar code. In such 
instances, the bar code may be formatted in any way that meets the 
technical requirements of the bar coding system that is employed.
    While the presence of a bar code is immediately obvious, the 
presence of other AIDC technologies, such as RFID and near-field 
communication, may not be so obvious. If a device user is not aware of 
the availability of AIDC technology, this may impair the rapid and 
accurate identification of the device. To ensure that the presence of 
AIDC technology is obvious, if the AIDC technology is not visible on 
the label of the device or on the device package, the labeler would 
also have to include a symbol on the device label or on the device 
package that provides notice of the presence of AIDC technology; see 
proposed Sec.  801.45(c). The symbol may be a symbol endorsed in an 
international or national standard recognized by FDA under section 
514(c) of the FD&C Act (for example, symbols specified for differing 
types of RFID systems), a symbol generally recognized by the persons 
who typically use the device, or the generic symbol shown in proposed 
Sec.  801.45(c).
8. When would a device have to be directly marked with a UDI?
    We restrict our proposed direct marking requirements, proposed 
Sec.  801.50, to three categories of devices, because these devices 
present unique risks that we believe would be better controlled through 
direct marking:
     An implantable device;
     A device that is intended to be used more than once and 
that is intended to be sterilized before each use; and
     Stand-alone software that is a ``device'' under Sec.  
201(h) of the FD&C Act.
    An implantable device, proposed Sec.  801.50(a)(1)--An implantable 
device is, by definition, intended to be used for at least 30 days (see 
the proposed definition of implantable device at Sec.  801.3). Once 
implanted, the device is separated from its label and labeling, which 
may prevent accurate identification of the device over time, 
potentially undermining the accuracy of problem reporting and delaying 
the identification and resolution of problems with the implanted 
device. But if the UDI is evident upon explantation of the device, or 
is retrievable through AIDC technology, it will still be possible to 
unambiguously identify the implant.
    A device that is intended to be used more than once and that is 
intended to be sterilized before each use, proposed Sec.  
801.50(a)(2)--These devices may also be used over an extended period of 
time, with the need for effective cleaning and sterilization before 
each new use providing a complicating factor. It is particularly 
important to understand precisely the identity of each such device, 
because effective sterilization methods may be different for different 
types of devices. If a device is not effectively sterilized, and is 
then used on a patient, severe harm may result. UDI labeling, and the 
associated data available from the GUDID, will help ensure device users 
have the information they need to avoid such harm.
    Stand-alone software, proposed Sec.  801.50(a)(3)--This category 
excludes software that is an integrated component of a device, such as 
software embedded in a chip that is part of a circuit in a device. This 
includes stand-alone software that meets the definition

[[Page 40752]]

of ``device'' under Sec.  201(h) of the FD&C Act, e.g., prostate auto-
contouring software that assists clinicians in generating estimates of 
the anatomy boundary contours of the prostate gland in computed 
tomography scans, magnetic resonance images, and ultrasound scans to 
aid in patient diagnosis, treatment planning, and post-treatment 
monitoring. Stand-alone software is unique in that it may be possible 
to obtain, use, and update it without ever receiving a physical package 
bearing a physical label. For example, software may be initially 
obtained via the Internet, and it is very common for patches, updates, 
and new versions to be provided through the Internet. Furthermore, even 
when the software is identical to the package and label description, it 
is typically used only after being installed on a computer (or multiple 
computers, or on a network) and typically the package and label (and 
the physical media, such as a CD-ROM or DVD-ROM) are no longer used. 
Additionally, software may be transferred from one installation to 
another without any external indication. All of these factors make it 
highly likely that users of stand-alone software will not have ready 
access to the package or label, or if they do, that the software 
differs from the label description. By requiring a simple form of 
direct marking as part of the software itself, we overcome these 
problems and ensure that users can readily and precisely identify 
stand-alone software. In contrast to stand-alone software, software 
that is a component of a device will be adequately identified by the 
UDI on that device's label and package.
    The form of direct marking that would be required depends on which 
of these categories the device falls within. See proposed Sec.  
801.50(c). If your device is an implantable device, or is intended to 
be used more than once and to be sterilized before each use, the direct 
marking would have to be provided through either or both of the 
following:
     Easily-readable plain-text;
     AIDC technology, or any alternative technology that will 
allow for identification of the device. Examples include providing the 
UDI of the device on demand to an external reader or sensor, or making 
the UDI or a barcode or other representation of the UDI discernible to 
an x-ray or other imaging system.
    If your device is stand-alone software, the direct marking would 
have to be provided through either or both of the following:
     An easily-readable plain-text statement displayed whenever 
the software is started;
     An easily-readable plain-text statement displayed in 
response to a menu command (e.g., an ``About * * *'' command).
    We seek comments about the utility of marking stand-alone software 
in this manner.
    The UDI conveyed by the direct marking may be either the UDI that 
appears on the label of the device, or a different UDI used to 
distinguish the unpackaged device from the device while it remains in 
packaged form. See proposed Sec.  801.50(b). We permit the use of a 
different UDI to distinguish the unpackaged device because that is 
consistent with both current direct marking practices and the 
objectives of this rule.
    The requirement for direct marking of a device would go into effect 
two years after the date specified by proposed Sec.  801.20 for the 
device to bear a UDI on its label; see proposed Sec.  801.50(d). We 
believe this will provide the labeler adequate time to implement an 
appropriate direct-marking methodology for any device that would be 
subject to the requirements of proposed Sec.  801.50. We seek comments 
on whether this is an appropriate amount of time in which to make this 
provisions effective.
    Although our proposed direct marking requirements apply only to the 
three categories of devices identified by proposed Sec.  801.50(a), we 
recognize that even within those categories, direct marking will not 
always be appropriate or feasible. Proposed Sec.  801.50(e) provides 
reasonable exceptions to the requirement for direct marking; direct 
marking would not be required when any of the following apply--
     Direct marking would interfere with the safe and effective 
use of the device; proposed Sec.  801.50(e)(1). For example, it is 
possible that direct marking would interfere with the safe and 
effective use of orthopedic bone screws because direct marking could 
adversely affect the structural integrity of the screw. Direct marking 
may also interfere with the safe and effective use of instruments used 
in arthroscopic surgery because direct marking could create irregular 
surfaces that could reduce the effectiveness of sterilization 
procedures and harbor bacteria or other pathogens.
     Direct marking is not technologically feasible; proposed 
Sec.  801.50(e)(2). To be technologically feasible, it must be possible 
to place a direct marking on the device using readily-available 
technology, and it must be possible for that direct marking to be read 
in the environments it is intended to be used, again using readily-
available technology (generally meaning technologies that are typically 
present in the environment where the device is used).

For example, it is not technologically feasible to directly mark 
polymethylmethacrylate (PMMA) bone cement, classified at Sec.  
888.3027, because bone cement is sold in an amorphous state. Similarly, 
at the present time it is not technologically feasible to directly mark 
an aqueous shunt, classified at Sec.  886.3920, because the small size 
of the device would not permit inclusion of RFID or near-field 
communication, and any barcode, even if technically possible to apply, 
would be extraordinarily difficult to read with existing technologies. 
The technological feasibility of directly marking a device may change 
over time as new technologies are developed, enabling more direct 
marking options.
    In addition, the ``not technologically feasible'' exception from 
direct marking under Sec.  801.50(e)(2) can include circumstances, 
where, for a very small firm, the capital investment in technology to 
allow direct part marking so exceeds to benefit of applying the 
requirement that FDA could find direct part marking to be ``not 
technologically feasible.'' Factors to be considered in this instance 
would include: The number of devices otherwise subject to direct 
marking across which the capital investment can be amortized, current 
net earnings on expected sales of such devices, and the number of years 
required to recover the capital investment based on net earnings. FDA 
believes, however, when considering whether economic factors justify an 
exception under the ``not technologically feasible'' language, FDA 
should retain discretion to also consider the public health benefits of 
direct marking for a particular device based on its usage and risks.
     The device is intended to remain implanted continuously 
for a period of less than 30 days, unless the Commissioner determines 
otherwise in order to protect human health; proposed Sec.  
801.50(e)(3). This exception is inherent in the definition of 
implantable device, but is provided for clarity.
     The device has been previously directly marked; proposed 
Sec.  801.50(e)(4) We are proposing this exception both because of the 
practical difficulty and potential for confusion involved in applying a 
new direct marking when a direct marking already exists, and because 
multiple markings may compromise the device. We believe that continued 
use of the original direct marking will provide an adequate means to 
identify the device through its distribution and use. A labeler may,

[[Page 40753]]

however, remark a previously-marked device if the labeler concludes, on 
the basis of its own evaluation, that re-marking the device would not 
adversely affect the safety or effectiveness of the device.
     The device is sold at retail and bears a Universal Product 
Code (UPC); Sec.  801.50(e)(5).
     The device is software that is not stand-alone software, 
but is a component of a medical device; Sec.  801.50(e)(6). Examples of 
a software device that is not stand-alone include software incorporated 
into devices such as infusion pumps and software integrated and used to 
control systems such as MRI machines.
    If you determine that your device qualifies for an exemption from 
direct marking, you would have to document the basis of your decision 
in the design history file as required by Sec.  820.30(j) of the 
Quality System Regulation, see Sec.  801.50(f). If you determine that 
your device qualifies for an exemption from direct marking because 
direct marking would interfere with the safe and effective use of the 
device, see proposed Sec.  801.50(e)(1), or because you determine the 
device cannot be marked because it is not technologically feasible, see 
proposed Sec.  801.50(e)(2), you would have to send a notice to FDA, 
see proposed Sec.  801.50(g). Your notice to FDA would have to provide 
the following information:
     Identification of the exception, or exceptions, authorized 
by proposed Sec.  801.50(e) that you are invoking.
     An explanation of the factors that make the exception 
applicable to your device.
     The name of, and contact information for, the person who 
determined that the exception is applicable to your device.
    FDA does not intend to routinely respond to notices submitted under 
proposed Sec.  801.50(g). If we have a question concerning your notice, 
we may request additional information, review information in your 
device history records when we conduct an establishment inspection, or 
take such other action as may be appropriate.
9. After the requirement for UDI labeling goes into effect, May I 
continue to identify my device with the National Health-Related Item 
Code (NHRIC) or National Drug Code (NDC) number assigned to it?
    No; see proposed Sec.  801.57. FDA is phasing out the use of NHRIC 
and NDC numbers to identify medical devices, in favor of the UDI 
system. On the date your device would have to be labeled with a UDI, 
any NHRIC or NDC assigned to that device will be rescinded, and you 
will no longer be permitted to label your device with an NHRIC or NDC. 
Continued use of NHRIC or NDC codes on device labels and device 
packages would result in confusion concerning the appropriate 
identification of the device, and might obscure the distinction between 
drug and device identification systems. We seek comments on whether 
there are compelling reasons to continue to permit the use of these 
numbering systems.
10. Formatting of Dates Provided on Medical Device Labels
    Proposed Sec.  801.18 would require all dates provided on medical 
device labels to conform to a specified format: Month Day, Year, with 
the month shown as a three-letter abbreviation of the month (e.g. SEP 
30, 2012). This format--Month Day, Year (SEP 30, 2012)--is the format 
most commonly used in the United States and is the format most familiar 
to patients and consumers. Dates may be printed in any size and font 
that meet the general labeling requirements of part 801.
    When dates are formatted to use only numbers, inconsistencies in 
formatting from one device to another can lead to confusion concerning 
the proper interpretation of the date. For example, the expiration date 
January 12, 2013 may, at present, be expressed as 1-12-2013 (this is 
the format most commonly used in the United States) or as 12-1-2013 
(this is the format most commonly used in Europe). This could cause a 
patient or a health care professional to mistakenly continue to use the 
device for more than 10 months past the intended expiration date. 
Another source of potential confusion is the use of date formats that 
use only the month and year, such as 12-2011, 12-11, or December 2011. 
The omission of the precise day of the month creates uncertainty; 12-
2011 could indicate that use of the device should cease on the first 
day of December 2011, or the last day of December 2011. Furthermore, 
when a date uses a two-digit representation of year, it may not be 
clear that the number sequence represents a date. Use of a standard 
format consistent with the usage most often used and most readily 
recognized by consumers in the United States will eliminate any 
potential confusion concerning the appropriate interpretation of dates 
provided on medical device labels. (Ref. 8)
    The proposed date format may contribute to more accurate 
identification of a device by making it possible to distinguish between 
those devices that have passed an expiration or use-by date and those 
that have not. More accurate identification would make it easier to 
both avoid the risks of using ``expired'' devices and the costs of 
premature disposal of devices that have not actually reached an 
expiration or use-by date.
    We provide a limited exception in proposed Sec.  801.18(f) for 
electronic products to which a standard is applicable under subchapter 
J, Radiologic Health; 21 CFR 1010.3(a)(2)(ii) specifies the date format 
for such electronic products. We do not believe it is necessary to 
change this requirement for these products, because that standard uses 
the month and year of production, which does not involve the potential 
for confusion that an expiration date or use-by date may present.
    Proposed Sec.  801.18 would go into effect one year after we 
publish a final rule. We believe Sec.  801.18 should be implemented as 
rapidly as possible because it is designed to correct existing 
confusion concerning the interpretation of dates on medical device 
labels. We seek comments on whether this date format and associated 
effective date are feasible and appropriate, including whether the 
effective date should be linked to the UDI implementation date for each 
class of devices.

C. Requirements Relating to Issuing Agencies and Submission of Data to 
the Global Unique Device Identification Database (Part 830)

    New part 830 would provide FDA's requirements for the composition 
and issuance of UDIs, explain the process FDA would follow to accredit 
an ``issuing agency'' to operate a system for the issuance of UDIs, 
explain when FDA would act as an issuing agency, and would provide 
requirements pertaining to the GUDID, including when and what data must 
be submitted to the GUDID and by whom.
1. Definitions
    We are proposing, in new Sec.  830.3, definitions for important 
terms used by FDA's unique device identification system under this 
rule. The terms proposed for inclusion in Sec.  830.3 are discussed in 
this section II.C; where a term is also defined in part 801, the 
definitions are identical.
    The following terms would have the same definition in both parts 
801 and 830; these terms are discussed earlier in this preamble--
     Automatic identification and data capture (AIDC).
     Device package.
     Expiration date.

[[Page 40754]]

     FDA, we, or us.
     Labeler.
     Lot or batch--This definition includes a definition of 
finished device.
     Specification.
     Shipping container.
     Unique device identifier (UDI).
     Universal product code (UPC).
     Version or model.
    The following additional terms are defined in proposed Sec.  
830.3--
    Issuing agency--This term would mean an organization accredited by 
FDA to operate a system for the issuance of UDIs. Our proposed rule 
permits multiple issuing agencies, and under certain circumstances FDA 
could act as an issuing agency.
    Global Unique Device Identification Database or GUDID--This term 
would mean the FDA-administered database that serves as a repository of 
information to facilitate the identification of medical devices through 
their distribution and use. The device identifier portion of a UDI 
would not be structured to provide specific information concerning a 
device; rather, the device identifier would serve as a reference number 
that would allow you to find information about the device by accessing 
information reporting to the GUDID. For example, you would not be able 
to parse out a segment that indicates that the device is a 
cardiovascular device, or that the device is packaged sterile, or that 
the device is marketed under a particular FDA premarket submission.
    Premarket submission--This term would mean any of the following 
types of applications:
     Premarket approval application--an application for 
approval of a device submitted under section 515(c) of the FD&C Act.
     Product development protocol--the application described in 
section 515(f) of the FD&C Act.
     Premarket report means a report submitted under section 
515(c)(2) of the FD&C Act.
     Humanitarian device exemption application--an application 
for approval of a humanitarian use device submitted under section 
520(m) of the FD&C Act.
     Biologics license application means an application for 
approval of a device submitted under section 351 of the Public Health 
Service Act.
     Premarket notification submission means a report submitted 
under section 510(k) of the FD&C Act.
     New drug application for a transitional device means a new 
drug application for a medical device that was regulated by FDA as a 
new drug prior to May 28, 1976, the date of enactment of the Medical 
Device Amendments of 1976.
    Small business--This term would mean a medical device manufacturer 
with 500 or fewer employees, or a medical device relabeler or 
repackager with 100 or fewer employees. This is consistent with how the 
Small Business Administration defines ``small business'' under the 
Small Business Act (5 U.S.C. 631). We are proposing this definition 
only to help explain when FDA would act as an issuing agency under 
proposed subpart D of part 830.
2. What would be the requirements for the composition and issuance of a 
valid Unique Device Identifier?
    In order to ensure that all UDIs will meet the public health 
objectives of this rule, and to ensure that device user facilities, 
health care professionals, FDA, and others will be able to make 
efficient and effective use of the UDI system, we are proposing every 
UDI must be issued under a system operated by FDA or an FDA-accredited 
issuing agency, see proposed Sec. Sec.  830.20(a), and must conform to 
the international standards that would be incorporated by reference by 
proposed Sec.  830.10. UDIs would have to be composed only of 
characters from a single character set defined by one of these 
incorporated standards; see proposed Sec.  830.20(b). Conformity to 
these international standards will ensure that each issuing agency's 
system of assigning UDIs will be broadly compatible and capable of 
fulfilling our public health objectives.
    Incorporation by reference of ISO/IEC 646:1991, Information 
technology--ISO 7-bit coded character set for information exchange, 
would limit the plain-text version of a UDI to a particular set of 
alpha-numeric characters. Incorporation by reference of ISO/IEC 15459-
2:2006, Information Technology--Unique identifiers--Part 2: 
Registration procedures, would require organizations wishing to become 
issuing agencies to apply to the Registration Authority and obtain an 
Issuing Agency Code (IAC). This assures that multiple issuing agencies 
can create globally unique identifiers and minimizes the risk of 
duplicative identifiers. Incorporation by reference of ISO/IEC 15459-
4:2008, Information technology--Unique identifiers--Part 4: Individual 
items, would provide the framework for the development of UDIs for 
serialized devices; and incorporation by reference of ISO/IEC 15459-
6:2007, Information technology--Unique identifiers--Part 6: Unique 
identifier for product groupings, would provide the framework for the 
development of UDIs for lot or batch controlled devices.
    As explained in section I.B of this document, requiring the use of 
issuing agencies and conformity with international regulatory 
cooperation activities and internationally recognized identification 
standards would best serve the public health objectives of this rule by 
ensuring the uniqueness, consistency, and broad compatibility of device 
identification, and avoiding the confusion and inefficiency that would 
result if every labeler generated their own non-standardized 
identifiers or if FDA alone issued identifiers.
3. Use and Discontinuation of a Device Identifier
    Under proposed Sec.  830.40(a), you would be prohibited from using 
more than one device identifier from any particular accredited system 
to identify a particular version or model of a device. If you use 
systems operated by two or more issuing agencies, you would be 
permitted to identify that device with one identifier from each system 
that you use. Under proposed Sec.  830.40(b), you would be prohibited 
from simultaneously using one device identifier to identify more than 
one version or model of a device.
    If you discontinue a particular version or model of a device, you 
would be prohibited from reassigning the device identifier to another 
device; see proposed Sec.  830.40(c). If you re-introduce a 
discontinued device and no changes have been made that would require a 
new device identifier, you would be permitted to use the same device 
identifier that you previously used to identify the device; see 
proposed Sec.  830.40(c). If your issuing agency ceases to be 
accredited, FDA would permit you to continue to label a device using 
the device identifier issued under the system operated by the issuing 
agency until such time as this rule requires you to discontinue use of 
the UDI; see proposed Sec.  830.40(d).
    The approach used by proposed Sec.  830.40 is necessary to ensure 
that each device identifier identifies only one version or model of a 
device. Use of a given device identifier to identify more than one 
version or model, or the use of more than one identifier from a 
particular issuing agency to identify a given version or model, would 
inevitably lead to confusion in the identification of devices, and 
would seriously undermine the public health objectives of this rule.
4. What changes would require a new device identifier?
    It is essential for each distinct version or model of a device to 
be uniquely identified so that it may be rapidly and

[[Page 40755]]

accurately distinguished from every other device. You would be 
permitted to replace one device identifier with another (in other 
words, discontinue one UDI and begin using another) for a particular 
version or model of a device for any reason, but you would be required 
to use a new device identifier in the circumstances discussed under 
this question 4. The changes that would require a new device identifier 
are set forth in proposed Sec.  830.50, and include--
     You make a change that has the potential to affect the 
safety or effectiveness of the device; see proposed Sec.  830.50(c). If 
a change has the potential to affect safety or effectiveness, it will 
be important for the health care community to be aware of the change in 
order to distinguish between the updated version or model and the prior 
version or model.
     You change from a nonsterile package to a sterile package, 
or from a sterile package to a nonsterile package; see proposed Sec.  
830.50(d). Health care practitioners and patients need to be aware of 
changes relating to sterility, because of the serious consequences that 
may result if an unsterile device is thought to be sterile and is used 
without undergoing necessary sterilization. Consequently, it is 
critically important for each sterile and nonsterile version or model 
of a device to be easily distinguished and correctly identified.
     You change the quantity of devices in a package, which 
results in a new device package and a new version or model; see 
proposed Sec. Sec.  801.3 and 830.50(b). Thus, a different device 
identifier would be required for an individually packaged device and 
for a box of five device packages. In order to adequately identify a 
device throughout distribution and use and to be consistent with 
current practice and standards, different types of packages would have 
different identifiers. That way, anyone using the system can know 
exactly what they sent and received when and can more easily and 
effectively identify and respond to problems. For example, they would 
know what to look for if there is a recall or other problems, and would 
be able to more narrowly target corrective actions by device package.
     You relabel a device that was previously labeled with a 
UDI by another labeler; proposed Sec.  830.50(e). Because a relabeled 
device needs to be distinguishable from the version or model that bears 
the original label and you are responsible for your own labeling, you 
would not be permitted to use the UDI assigned by the original labeler. 
In addition, if you relabel a device, proposed Sec.  830.60 would 
require you to keep a record showing the relationship of the prior 
device identifier (the identifier assigned by the prior labeler) to the 
new device identifier (your identifier).
    All of these changes would result in a new version or model, and 
consequently would require a new device identifier; you would not be 
permitted to continue to use an existing identifier to identify the new 
version or model.
5. How would FDA accredit an issuing agency?
    An issuing agency would be an FDA-accredited private nonprofit 
organization or a State agency that operates a system for assignment of 
UDIs pursuant to this rule. See proposed Sec.  830.100. We selected the 
term ``issuing agency'' because it is the term used in the 
international standards incorporated by reference by proposed Sec.  
830.10, and is a term familiar to many labelers. We would require the 
issuing agency to be a State agency or nonprofit organization in order 
to minimize potential conflicts of interest and to help assure that the 
fees assessed are reasonable to small businesses. FDA would accredit a 
private nonprofit organization or a State agency, see proposed Sec.  
830.100(a), if it meets all of the following criteria; see proposed 
Sec.  830.100(b):
     The system uses UDIs that meet the requirements of the 
proposed rule to adequately identify a device through its distribution 
and use. See proposed Sec.  830.100(b)(1).
     The system it operates conforms to the international 
standards incorporated by reference at proposed Sec.  830.10; see 
proposed Sec.  830.100(b)(2). Conformance to those standards helps 
ensure that devices will be uniquely and consistently identified and 
that each system will be broadly compatible with other systems and will 
achieve the objectives of this rule.
     The issuing agency makes its system available to all users 
according to a single set of consistent, fair, and reasonable terms and 
conditions; see Sec.  830.100(b)(3). This means that the issuing agency 
would be prohibited from discriminating against, or giving preferential 
treatment to, a user for any reason that is not directly related to the 
efficient and orderly operation of the system in a manner that complies 
with this rule.
    An organization or State agency that wishes to be accredited as an 
issuing agency would have to submit an application to FDA and include 
all the information listed in proposed Sec.  830.110. This includes 
contact information; evidence of nonprofit status; information on the 
system that will be used to assign UDIs; fee schedules, if any, with an 
explanation of any fee waivers or reductions available to small 
businesses; satisfactory assurances that the applicant would comply 
with the requirements of this rule; and other information required by 
FDA to clarify the application for accreditation. This information is 
necessary to ensure that each FDA-accredited issuing agency will be 
capable of effectively managing a system for the assignment of unique 
identifiers in full compliance with the requirements of this rule.
    The initial accreditation will be for a period of 3 years, and 
renewed accreditation will be for a period of 7 years; see proposed 
Sec.  830.110(f). An issuing agency would have to inform FDA that it 
wishes to renew its accreditation and would have to submit a complete 
renewal application at least six months prior to expiration of its 
accreditation, see proposed Sec.  830.110(b). These time frames would 
provide FDA adequate time to evaluate the performance of issuing 
agencies before each application for renewed accreditation.
    Within 60 days of receipt of any application for accreditation, FDA 
will notify the applicant of any deficiencies and we will request 
correction of those deficiencies within 60 days. The applicant may 
request an extension if it needs additional time to correct those 
deficiencies. If the deficiencies are not resolved to FDA's 
satisfaction within the specified time period, we may deny the 
application for accreditation; see proposed Sec.  830.110(c)(2). When 
we have completed our review, we will notify the applicant whether its 
application for accreditation has been granted or denied. That 
notification shall list any conditions associated with approval or 
state the reasons for denial; see proposed Sec.  830.120(c)(3). If we 
deny an application for accreditation, we will advise the applicant of 
the circumstances under which an application may be resubmitted; see 
proposed Sec.  830.120(c)(4). If FDA does not reach a final decision on 
a renewal application before the expiration of an issuing agency's 
accreditation, the approval will be deemed extended until FDA reaches a 
final decision on the application; see proposed 830.120(c)(5).
6. What would be the responsibilities of an FDA-accredited issuing 
agency?
    In order to ensure that all device identifiers are unique and meet 
the proposed requirements, and that all system users are treated 
fairly, FDA

[[Page 40756]]

would need to maintain effective oversight of issuing agencies. Under 
proposed Sec.  830.120, an issuing agency would be responsible for--
     Operating a system for assignment of UDIs that meets the 
requirements of proposed Sec.  830.20 and the standards incorporated by 
reference at proposed Sec.  830.10.
     Making information available concerning its system for the 
assignment of UDIs.
     Maintaining a list of labelers that use its system for the 
assignment of UDIs and providing FDA with a copy of the list each year.
     Upon request, providing FDA with information concerning a 
labeler that is employing the issuing agency's system.
     Remaining in compliance with the eligibility and 
accreditation criteria set forth in proposed Sec.  830.100.
7. How would an issuing agency relinquish its accreditation, and how 
would FDA suspend or revoke an issuing agency's accreditation?
    An issuing agency would be permitted to relinquish its 
accreditation before expiration of its current term of accreditation by 
submitting a letter stating its intent to FDA at least 9 months before 
the date it will relinquish its accreditation. See proposed Sec.  
830.110(d). If an issuing agency relinquishes its accreditation and 
duties before expiration of its current term of accreditation, it would 
have to notify all labelers that are participating in the issuing 
agency's UDI system, in a manner and time period approved by FDA, of 
the date that the issuing agency will cease to serve as an issuing 
agency. See proposed Sec.  830.110(e).
    Under proposed Sec.  830.130, FDA may suspend or revoke the 
accreditation of an issuing agency if we find, after providing the 
issuing agency with notice and opportunity for an informal hearing, 
that the issuing agency:
     Has been guilty of misrepresentation in obtaining its 
accreditation;
     Failed to fulfill the responsibilities of an issuing 
agency outlined in proposed Sec.  830.120; or
     Has violated or aided and abetted in the violation of any 
regulation promulgated pursuant to sections 510(e) or 519(f) of the 
FD&C Act; these provisions authorize regulations prescribing a uniform 
system for the identification of devices, and require regulations 
establishing a unique device identification system.
    We modeled these criteria on the approach we use under the 
Mammography Quality Standards Act, which gives FDA authority to suspend 
or revoke the accreditation of mammography facilities. See 21 CFR 
900.14.
8. When would FDA act as an issuing agency?
    FDA would act as an issuing agency during any period where there is 
no accredited issuing agency (for example, if there is no accredited 
issuing agency by the time UDI labeling requirements go into effect 
pursuant to proposed Sec.  801.20). See proposed Sec.  830.200(a). In 
such a circumstance, FDA would have to act as an issuing agency in 
order for the unique device identification system to function.
    FDA would also act as an issuing agency if we determine that a 
significant number of small businesses would be substantially and 
adversely affected by the fees required by all accredited issuing 
agencies. See proposed Sec.  830.200(b). We have included this 
provision because we are mindful that small device manufacturers may be 
concerned that they might face significant, recurring fees required by 
an issuing agency to participate in its system. We anticipate that 
issuing agencies will be sensitive to the needs of small businesses, so 
that FDA will not have to invoke this authority and act as an issuing 
agency.
    If FDA acts as an issuing agency, we would not, under current law, 
assess a fee for our services. Any labeler would be permitted to use 
FDA as its issuing agency, regardless of whether the labeler is 
considered a small business. See proposed Sec.  830.210. If it becomes 
necessary for FDA to act as an issuing agency, we would expect to issue 
guidance explaining how FDA's issuing agency would function.
    We may end our services as an issuing agency if we determine that 
the conditions that prompted us to act no longer exist and that ending 
our services would not be likely to lead to a return of the conditions 
that prompted us to act. See proposed Sec.  830.220(a). When we end our 
services as an issuing agency, we would allow a labeler to continue to 
use a device identifier assigned under FDA's unique device 
identification system until such time as proposed Sec.  830.50 requires 
the use of a new device identifier. See proposed Sec.  830.220(b).
9. What devices would be subject to GUDID data submission requirements?
    Under proposed Sec.  830.300(a), any device that would have to be 
labeled with a UDI under proposed Sec.  801.20 would be subject to 
GUDID data submission requirements. This would not include a device, 
other than a prescription device, sold at retail and such devices when 
delivered directly to a hospital or other health care facility. The UDI 
itself would not provide any information concerning the device; it 
would serve as a key to locate information in the GUDID. The labeler 
would not be required to submit information concerning any device whose 
label is not required to bear a UDI because the device is subject to a 
labeling exception under proposed Sec.  801.30, proposed Sec.  801.35, 
or proposed Sec.  801.128(f)(2), even when the labeler voluntarily 
includes a UDI on the label of such a device; see proposed Sec.  
830.300(b). When a labeler voluntarily includes a UDI on the label of a 
device pursuant to proposed Sec.  801.40, the labeler would be 
permitted, but not required to, submit information concerning that 
device to the GUDID; see proposed Sec.  830.300(c).
10. Would FDA ever reject data submitted to the GUDID or remove data 
from the GUDID?
    FDA would reject or remove information submitted to the GUDID for 
any of the reasons outlined in proposed Sec.  830.300(d). These 
exclusions would prevent misuse of the GUDID for purposes other than 
those that underlie this rule and would help ensure the accuracy and 
reliability of information in the GUDID.
    We do not intend to remove historical data from the GUDID. Once 
data has been submitted to the GUDID, unless we act to reject or remove 
that data pursuant to proposed Sec.  830.300(d), we would retain that 
data and make it available to the public without regard to whether a 
device remains in interstate commerce and without regard to any 
expiration date of a device.
11. What device identification data would I have to submit to the 
GUDID?
    Each labeler would be required to provide minimal information about 
itself, allowing FDA to communicate with the labeler; see proposed 
Sec.  830.310(a). For each version or model, the labeler (specifically, 
the contact for device information) would be required to submit the 
following information; see proposed Sec.  830.310(b)--
    (1) The device identifier portion of the UDI associated with the 
version or model.
    (2) When reporting a substitution of a new device identifier that 
will be used in lieu of a previously-reported identifier, the device 
identifier that was previously assigned to the device. This would allow 
us to link all UDIs pertaining to a given device. The requirement will 
also make it easier to

[[Page 40757]]

report such changes, because by referencing existing data, only the new 
identifier will need to be reported, rather than the full data set 
required for a new device.
    (3) If proposed Sec.  801.50 requires the device to bear a UDI as a 
permanent marking on the device itself, either--
     A statement that the device identifier that appears as a 
permanent marking on the device is identical to that reported under 
proposed Sec.  830.310(b)(3)(i), or
     The device identifier portion of the UDI that appears as a 
permanent marking on the device. We would permit a device marked 
pursuant to proposed Sec.  801.50 to use a different device identifier 
than that reported under proposed Sec.  830.310(b)(3)(i) because this 
approach is already in common use (Ref 7) and the link provided by this 
reporting requirement will ensure adequate identification of the 
device.
    (4) The proprietary, trade, or brand name of the device as it 
appears on the label of the device. This, and the following 
requirement, are very basic, pervasive forms of identification used for 
practically all devices, and are essential to the adequate 
identification of the device.
    (5) Any version or model number or similar reference that appears 
on the label of the device.
    (6) If the device is labeled as sterile, a statement to that 
effect. This information is essential to the adequate identification of 
the device, because similar devices may be marketed in a sterile form 
that is essentially ready for immediate use, and in a nonsterile form 
that requires the user to sterilize the device prior to use. If a 
nonsterile device is used on a patient in a situation where sterility 
is required, serious injury can occur.
    (7) If the device is labeled as containing natural rubber latex 
that contacts humans, or is labeled as having packaging containing 
natural rubber latex that contacts humans, a statement to that effect. 
This information is essential to the adequate identification of the 
device, because in many instances a device that contains latex is 
visually indistinguishable from a similar device that is free of latex. 
If there is any confusion concerning the presence of latex, there is a 
risk that a device may be inappropriately used on patients or by users 
who are sensitive to latex proteins and at risk of severe anaphylactic 
reaction when exposed to latex proteins.
    (8) If the device is available in more than one size, the size of 
the particular version or model, together with the unit of measure, as 
it appears on the label of the device. Confusion concerning the size of 
a device may result in inappropriate selection and use of a device.
    (9) The type of production identifiers that appear on the label of 
the device. We would not require the reporting of the actual production 
identifiers to the GUDID. Such an approach would be extraordinarily 
difficult to administer and would impose significant costs and burdens 
on labelers. Instead, we would require the labeler to indicate which of 
the four types of production identifiers the labeler uses to help 
identify particular devices within a given version or model. By 
knowing, for example, that a device has an expiration date, a user of 
that device will be aware that a precise identification of the device 
will most probably refer to the expiration date. This may be quite 
important at times, such as when a recall is underway that extends to a 
certain lot or batch, a certain range of serial numbers, or a certain 
range of expiration or manufacture dates.
    (10) The FDA premarket submission number of an approved or cleared 
device, or a statement that FDA has by regulation exempted the device 
from premarket notification. This information is essential to linking 
data in the GUDID with other existing FDA data sources. This would 
allow FDA to link the UDI to additional information relevant to the 
identification of the device, while minimizing the reporting burdens 
imposed on the labeler.
    (11) The FDA listing number assigned to the device. This 
information is also essential to linking data in the GUDID with other 
existing FDA data sources.
    (12) The GMDN code for the device. GMDN is a comprehensive system 
of generic descriptors (preferred terms) with definitions used to 
generically identify medical devices. The main purpose of the GMDN is 
to provide regulatory authorities and other users with a single naming 
system that will support patient safety by facilitating data exchange 
between regulatory authorities, including the exchange of post-market 
surveillance information. We believe that the use of GMDN in the UDI 
Database would facilitate the organization of the database and allow 
users to quickly and efficiently search the database. At this time GMDN 
data is not available to the public unless a fee is paid to the GMDN 
Agency. We believe, however, that by the time we publish a final rule, 
GMDN data will be available to the public at no cost. We will not 
include this requirement in our final rule if GMDN data is not freely 
available by the time we publish a final rule.
    (13) The number of individual devices contained in each device 
package. This would allow the GUDID to distinguish among different 
device packages.
    Proposed Sec.  830.310(b) would require information for each 
version or model of a device, which would include different device 
packages containing identical devices. To avoid submission of 
duplicative information, FDA plans to structure the data submission 
process so that labelers would only need to provide each piece of 
information once. For example, if a device is sold in a box of three 
and a box of five, you would need to provide all of the applicable 
information that would be required by proposed Sec.  830.310(b) for any 
one of these device packages. For the other device package (and for any 
additional device packages added later), you would need to submit only 
the device identifier portion of the UDI, Sec.  830.310(b)(1), and the 
number of individual devices in the additional or new device package, 
Sec.  830.310(b)(13).
12. How would I have to submit device identification data to the GUDID?
    Each labeler would have to designate an individual to serve as a 
point of contact with FDA on matters relating to the identification of 
medical devices marketed by the labeler. This contact could be an 
existing contact, such as the official correspondent of a registered 
establishment, or any other person. The contact would be responsible 
for ensuring FDA is provided with all information required by this 
regulation, but would be permitted to authorize an FDA-accredited 
issuing agency or some other person to provide information to FDA. See 
proposed Sec.  830.320(a).
    The proposed rule would require electronic submission except where 
it is not technologically feasible for a labeler to submit information 
electronically. See proposed Sec.  830.320(b). We expect this will be 
extraordinarily rare. FDA's current thinking is that we would provide 
two ways to submit data electronically to the GUDID, and we would 
describe these methods in a future draft guidance document. We believe 
this approach will meet the needs of both large and small labelers, 
will minimize the costs of submitting, receiving, and processing GUDID 
data, and will ensure a high level of accuracy in the data submitted. 
We welcome comments on these approaches at this time, and will also 
solicit comments in any future draft guidance on this issue.
    The two submission methods we are considering are--

[[Page 40758]]

     Data could be submitted as part of a structured product 
label (SPL) conforming to an ANSI/Health Level Seven (HL7) format (Ref. 
7) that meets specifications set by FDA. We believe this is the 
approach most larger labelers would prefer, as it is based on an 
existing international standard that can readily accommodate the 
efficient submission of multiple records. HL7 SPL is already used for 
submission of data to FDA, so many labelers are already familiar this 
approach and would face only minimal difficulty in adapting it for 
submission of UDI data.
     Each data element could be entered directly into the GUDID 
through a secure Internet site designed for simple, low-volume data 
entry with on-line help, similar to the approach currently used for 
electronic registration and listing. We believe this approach may be 
preferred by some small labelers that would need to provide data for 
only a few devices.
    We would allow each labeler to use either, or both, of these 
methods. We intend to provide the GUDID system with a means of 
detecting erroneous or non-compliant data entry; for example, if you 
try to submit a device identifier that does not conform with the 
international standards incorporated by reference at proposed Sec.  
830.10, we would reject that submission.
13. When would I have to submit device identification data to the 
GUDID?
    You would first have to submit data concerning a version or model 
of a device to the GUDID no later than the date the label of the device 
must bear a UDI; see proposed Sec.  830.330(a). Proposed Sec.  801.20 
phases in our UDI labeling requirements over several years, and 
consequently proposed Sec.  830.330(a) would phase in the rule's data 
submission requirements following the same schedule. See table 7 of 
this document, Effective Dates of UDI Regulatory Requirements for an 
overview of how we would phase in these requirements. A labeler who 
wishes to submit information concerning a device prior to the effective 
date under proposed Sec. Sec.  801.20 and 830.330(a) may submit a 
request to FDA to do so. FDA will accommodate such requests when 
consistent with our ability to process the additional information in an 
orderly manner.
    Once your device becomes subject to UDI labeling and GUDID data 
reporting requirements, you would be required to update the information 
you reported to the GUDID whenever the information changes. The update 
would have to be submitted no later than the date a device is first 
labeled with the changed information. If the information does not 
appear on the label of a device (e.g., the Global Medical Device 
Nomenclature generic descriptor or the FDA device listing number), the 
update would have to be submitted within 10 days of the change. See 
proposed Sec.  830.330(b).
14. Would I be permitted to submit information to the GUDID that is not 
required by FDA?
    Under our proposal, you would not be permitted to submit any 
information to the GUDID other than that required by proposed Sec.  
830.310, except where FDA acts to permit the submission of specified 
additional information, termed ancillary information; see proposed 
Sec.  830.340(a). We will provide information concerning the ancillary 
information that we will accept through the GUDID Web site; see Sec.  
830.340(b). You would be permitted, but would not be required, to 
submit any or all of the ancillary information identified by FDA. We 
may periodically change the ancillary information that may be submitted 
to the GUDID; we would announce any change at least 60 days before the 
change takes effect; see proposed Sec.  830.340(c).
15. What records would a labeler be required to maintain concerning its 
UDIs?
    Each labeler would be required to retain records linking all UDIs 
to the associated version or model; see proposed Sec.  830.350. The 
records would have to be retained until three years after the date the 
labeler ceases to market the version or model. This will ensure that 
the information is readily available to the labeler and to FDA, for 
example, if needed to conduct a recall or take other corrective actions 
regarding one version or model or more of a device. Compliance with 
this section would not relieve the labeler of the need to comply with 
recordkeeping requirements of any other FDA regulation.
16. Who would have access to the information I submit to the GUDID?
    We have determined that free, easy, and unlimited access to 
information in the GUDID is essential to the adequate identification of 
devices through their distribution and use, that health care 
professionals, patients, and the general public all have substantial 
needs for access to such information, and that the public health 
objectives of this rule would be significantly harmed if we attempted 
to impose any restrictions on access. Consequently, FDA intends to post 
all information in the GUDID (with one exception, discussed at the end 
of this paragraph) on our Web site so that it will be readily available 
to the public, and we intend to include features in the UDI Web site to 
facilitate inquiries concerning a specific device and searches for 
general or specific information. This includes information that you 
would be required to submit pursuant to proposed Sec.  830.310 and 
ancillary information that you would be permitted to submit pursuant to 
Sec.  830.340. We have determined that none of the information that 
would be required to be submitted under this rule would constitute 
trade secret, confidential commercial information, or personal privacy 
information, or would otherwise be prohibited from public release. We 
would not add any categories of ancillary information that might 
include information that is prohibited from public disclosure. The one 
type of information we would not post is listing numbers because they 
serve important governmental functions (e.g., admissibility 
determinations for shipments of foreign-origin FDA-regulated products 
seeking to enter domestic commerce) that would be harmed if they were 
made public.

D. Conforming Amendments

    We are proposing several conforming amendments to explain how we 
will integrate the use of UDIs and device identifiers, and data from 
the UDI system's GUDID, into FDA's existing regulatory systems and 
processes. These amendments are identified and briefly discussed in 
this section II.D.
Part 16, Regulatory Hearing Before the Food and Drug Administration
    We propose to amend part 16 (21 CFR part 16) to state that an 
informal regulatory hearing is available when FDA acts under Sec.  
830.130 to suspend or revoke the accreditation of an issuing agency.
Part 803, Medical Device Reporting
    We propose to amend Sec. Sec.  803.32, 803.42, and 803.52 to 
require UDIs to be included in individual adverse event reports 
submitted by device user facilities, importers, and manufacturers. We 
also propose to amend Sec.  803.33 to require a UDI, when available, to 
be provided with each adverse event reported in a user facility's 
annual report to FDA.
Part 806, Medical Devices; Reports of Corrections and Removals
    We propose to amend Sec. Sec.  806.10 and 806.20 to permit and 
encourage use of UDIs to identify devices that are the subject of 
reports of corrections and removals, and in records of corrections

[[Page 40759]]

and removals that are not required to be reported to FDA.
Part 810, Medical Device Recall Authority
    We propose to amend Sec.  810.10(b)(2) to indicate that FDA will 
include UDIs, when known, in the ``pertinent descriptive information'' 
we provide in a cease distribution and notification order issued under 
FDA's recall authority.
Part 814, Premarket Approval of Medical Devices
    We propose to amend Sec.  814.84(b) to require each periodic report 
for a class III device to include information on all device identifiers 
in effect at the time of the report, together with information on all 
device identifiers discontinued since the previous periodic report. 
This would not require any periodic report to include information 
concerning device identifiers discontinued prior to the effective date 
of a final rule. We are proposing this change to help ensure that UDIs 
and UDI data for class III devices are reported to the GUDID. This data 
will help device reviewers process PMA supplements and related PMAs 
more rapidly by making it easier to integrate relevant data into their 
reviews.
Part 820, Quality System Regulation
    We propose to amend Sec.  820.120(b), concerning the inspection of 
labels prior to release for storage or use, to include examination of 
the accuracy of the UDI within the scope of the labeling inspection.
    We propose to amend Sec.  820.184(f) to clarify that the device 
history record is to include any UDI or UPC that is used to identify 
the device. We regard this amendment as a clarification, as Sec.  
820.184(f) already requires the device history record to include 
``[a]ny device identification(s) and control number(s) used,'' and both 
a UDI and a UPC are within the scope of that requirement.
    We propose to amend Sec.  820.198(e)(3) to clarify that complaint 
records are to include any UDI or UPC that is used to identify the 
device. We regard this amendment as a clarification, as Sec.  
820.198(e)(3) already requires the complaint record to include ``[a]ny 
device identification(s) and control number(s) used,'' and both a UDI 
and a UPC are within the scope of that requirement.
    We propose to amend Sec.  820.200(d)(2) to clarify that a service 
report is to include any UDI or UPC that is used to identify the 
device. We regard this amendment as a clarification, as Sec.  
820.198(d)(2) already requires the service report to include ``[a]ny 
device identification(s) and control number(s) used,'' and both a UDI 
and a UPC are within the scope of that requirement.
Part 821, Medical Device Tracking Requirements
    We propose to amend Sec.  821.25(a)(2)(i) and (a)(3)(i) to 
authorize a manufacturer, when adopting a tracking methodology, to use 
a UDI of each tracked device when the UDI is necessary to provide for 
effective tracking of the devices.
    We propose to amend Sec.  821.30(a)(2) and (b)(2) to require a 
distributor or final distributor, respectively, upon purchasing or 
otherwise acquiring any interest in a tracked device, to include the 
UDI among other information to be provided to the manufacturer of the 
device.
    We propose to amend Sec.  821.30(c)(1) to require a multiple 
distributor to include the UDI of a device among the other information 
required in a written record each time the device is distributed for 
use by a patient.
Part 822, Postmarket Surveillance
    We propose to amend Sec.  822.9(a)(4) to require device identifiers 
be included among the information required in a postmarket surveillance 
plan submitted to FDA.

III. Legal Authority for the Proposed Rule

    Section 226 of FDAAA, Public Law 110-85 (2007), amended the FD&C 
Act by adding a new section 519(f) (21 U.S.C. 360i(f)). This section 
provides for FDA to issue regulations establishing a unique device 
identification system for medical devices. In addition, section 510(e) 
of the FD&C Act (21 U.S.C. 360(e)) authorizes FDA to issue regulations 
to ``prescribe a uniform system for identification of devices'' and to 
require persons to ``list such devices in accordance with such 
system.'' Therefore, FDA is issuing the provisions of this proposed 
rule that would establish a unique device identification system under 
sections 510(e), 519(f), and 701(a) (21 U.S.C. 371) of the FD&C Act 
(which provides FDA the authority to issue regulations for the 
efficient enforcement of the FD&C Act).
    Devices for which there has been a failure or refusal to furnish 
any material or information required by or under section 519 respecting 
the device are misbranded under section 502(t)(2) of the FD&C Act, 21 
U.S.C. 352(t)(2). The failure or refusal to furnish any material or 
information required by or under section 519 of the FD&C Act is a 
prohibited act under section 301(q)(1)(B) of the FD&C Act (21 U.S.C. 
331(q)(1)(B)).
    Section 701(a) of the act (21 U.S.C 371(a)) gives FDA the authority 
to promulgate regulations for the efficient enforcement of the act in 
order to ``effectuate a congressional objective expressed elsewhere in 
the Act'' (Association of American Physicians and Surgeons, Inc. v. 
FDA, 226 F. Supp. 2d 204 (D.D.C. 2002) (citing Pharm. Mfrs. Ass'n. v. 
FDA, 484 F. Supp. 1179, 1183 (D. Del. 1980)). By requiring a UDI to 
appear on the label of devices, and by establishing the GUDID, the 
proposed rule is designed to improve the accuracy and precision of 
adverse event reporting, as required by section 519(a) and (b) of the 
FD&C Act, which will enable FDA to more quickly and precisely identify 
device problems, such as safety and/or effectiveness concerns. Once a 
problem is identified, whether through improved reporting or otherwise, 
the presence of the UDI on the device label, packaging, and in the 
GUDID will enable FDA to more efficiently and effectively respond, and 
protect the public health by addressing the problem using one or more 
of the regulatory tools that Congress has provided for this purpose, 
such as notification or mandatory recall under section 518 of the FD&C 
Act (21 U.S.C. 360h), tracking under section 519(e) of the FD&C Act, 
ensuring the adequacy of a voluntary recall with the assistance of 
reports of corrections and removals as required by section 519(g) of 
the FD&C Act, or seizing a device that is adulterated under section 501 
of the FD&C Act (21 U.S.C. 351) and/or misbranded under section 502 of 
the FD&C Act (21 U.S.C. 352).
    Section 510(j) of the FD&C Act (21 U.S.C. 360(j)) requires listing 
information to be accompanied by, at minimum, the label, package 
insert, and a representative sampling of any other labeling for the 
device; see section 510(j)(1)(B)(ii). For certain categories of 
devices, all labeling must be submitted; see section 510(j)(1)(A) and 
(j)(1)(B)(i) of the FD&C Act. We expect most of the information that 
would be required to be submitted to the GUDID, see proposed Sec.  
830.310, is information that appears on the device label or in the 
package insert, and is included in the information that is required to 
be submitted to FDA by section 510(j) of the FD&C Act.
    The provisions of the proposed rule that would require UDIs to be 
included in various records and reports, allow the use of UDIs to 
identify devices subject to reports of corrections and removals and 
records of corrections of removals that are not required to be reported 
to

[[Page 40760]]

FDA, and require reporting of UDIs in periodic reports for class III 
devices, are issued under the authority of sections 519 and 701(a) of 
the FD&C Act.
    The provisions of the proposed rule that would amend the QSR by 
requiring examination of the accuracy of the UDI as part of the scope 
of the labeling inspection, that the device history record include any 
UDI or UPC, that complaint records include any UDI or UPC, and that the 
service report include any UDI or UPC, are issued under sections 520(f) 
and 701(a) of the FD&C Act.
    The provisions of the proposed rule that would require the 
inclusion of UDIs on reports regarding tracked devices is authorized by 
sections 519(e) and 701(a) of the FD&C Act.
    Finally, the provision of the proposed rule that would require that 
postmarket surveillance plans submitted to FDA include the device 
identifier of the devices involved is issued under sections 522 (21 
U.S.C. 360l), and 701(a) of the FD&C Act.

IV. Analysis of Impacts

    FDA has examined the impacts of the proposed rule under Executive 
Order 12866, Executive Order 13563, the Regulatory Flexibility Act (5 
U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Pub. L. 
104-4). Executive Orders 12866 and 13563 direct Agencies to assess all 
costs and benefits of available regulatory alternatives and, when 
regulation is necessary, to select regulatory approaches that maximize 
net benefits (including potential economic, environmental, public 
health and safety, and other advantages; distributive impacts; and 
equity). The Agency believes that this proposed rule is a significant 
regulatory action under Executive Order 12866.
    The Regulatory Flexibility Act requires Agencies to analyze 
regulatory options that would minimize any significant impact of a rule 
on small entities. Because we are uncertain whether the proposed rule 
would have a significant economic impact on a substantial number of 
small entities, this and other sections of the preamble and the full 
RIA (Ref. 10) constitute the Agency's regulatory flexibility analysis.
    Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires 
that Agencies prepare a written statement, which includes an assessment 
of anticipated costs and benefits, before proposing ``any rule that 
includes any Federal mandate that may result in the expenditure by 
State, local, and tribal governments, in the aggregate, or by the 
private sector, of $100,000,000 or more (adjusted annually for 
inflation) in any one year.'' The current threshold after adjustment 
for inflation is $139 million, using the most current (2011) Implicit 
Price Deflator for the Gross Domestic Product. The estimated costs of 
this proposed rule would result in a 1-year expenditure that exceeds 
this amount.
    This proposed rule would require the label and package of medical 
devices to bear a unique device identifier and would provide for 
alternative placement or an exception for a particular device or type 
of device. In addition, this proposed rule would require certain 
devices to be directly marked with a UDI, with exceptions. Medical 
device records throughout the required recordkeeping and reporting 
systems would need to be modified to include the UDI. Under this 
proposed rule FDA would establish the GUDID, a public database 
containing information about devices labeled with a UDI. The proposed 
rule would require labelers of medical devices to submit information 
concerning each device to the GUDID. In addition, the proposed rule 
would also establish the accreditation requirements for agencies that 
may operate a system for the issuance of UDIs and establish the 
conditions for when FDA might act as an issuing agency.

A. Summary of Costs

    The detailed data for this cost analysis were developed by ERG 
under contract to FDA and are presented in the full report ``Unique 
Device Identification (UDI) for Medical Devices,'' 2011 (cited in Ref. 
10).
    Table 3 of this document presents for each affected sector a 
summary of the estimated present value and the annualized domestic 
costs of this proposed rule over 10 years using discount rates of 7 
percent and 3 percent. Over 10 years, the present value of the domestic 
costs would be $514.0 million using a 7 percent discount rate and 
$588.6 million using a 3 percent rate, and the annualized costs would 
be $68.4 million using a 7 percent discount rate and $66.9 million 
using a 3 percent discount rate.

                                         Table 3--Summary of the Estimated Regulatory Costs of the Proposed Rule
                                                                   [2010 dollars] \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                     Total present value of cost over 10 years ($ million)         Total annualized costs over 10 years ($ million)
        Affected sectors         -----------------------------------------------------------------------------------------------------------------------
                                            3 Percent                     7 Percent                     3 Percent                     7 Percent
--------------------------------------------------------------------------------------------------------------------------------------------------------
Domestic Labelers...............  $571.5......................  $499.4......................  $65.0.......................  $66.5.
Issuing Agencies................  $1.0........................  $0.9........................  $0.1........................  $0.1.
FDA.............................  $16.1.......................  $13.7.......................  $1.8........................  $1.8.
Imports.........................  Not quantified..............  Not quantified..............  Not quantified..............  Not quantified.
                                 -----------------------------------------------------------------------------------------------------------------------
    Total Domestic Cost of the    $588.6......................  $514.0......................  $66.9.......................  $68.4.
     Proposed Rule.
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ Present value and annualized costs calculated at the beginning of the period.

1. Costs to Domestic Labelers
    The majority of the costs of this proposed rule would be incurred 
by labelers of medical devices. Labelers include manufacturers, 
reprocessors, specification developers, repackagers and relabelers that 
cause a label to be applied to a medical device. The estimated present 
value of the costs for domestic labelers over 10 years would be $499.4 
million at a 7 percent discount rate and $571.5 million at 3 percent. 
Over 10 years, the annualized costs for domestic labelers would be 
$66.5 million at a 7 percent discount rate and $65.0 million at 3 
percent. The largest components of one-time costs would include the 
costs to integrate the UDI into existing information systems, to 
install, test and validate barcode printing software and to train 
employees, and to purchase and install equipment needed to print and 
verify the UDI on labels. In addition, other significant components of 
one-time costs include costs to redesign labels of devices to 
incorporate the date format

[[Page 40761]]

within 1 year and to allow space for the UDI barcode, and the direct 
marking of certain devices.
    The largest annual cost components include labor, operating, and 
maintenance associated with equipment for printing operations, and 
labor related to software maintenance and training needed to maintain 
the UDI information system.
2. Costs to Issuing Agencies
    The estimated present value of costs over 10 years for two existing 
organizations, currently performing functions similar to those of an 
issuing agency under the proposed rule, to apply for FDA accreditation 
and comply with the proposed reporting requirements would be $0.9 
million at a 7 percent discount rate and $1.0 million at 3 percent. The 
annualized costs over 10 years would be $0.1 million at both 7 percent 
and 3 percent discount rates. In addition to these two organizations, 
there may be other nonprofit organizations or State agencies that might 
apply to FDA to become an issuing agency. In such cases, the estimated 
application preparation, legal, and reporting costs would apply to 
other organizations.
3. Costs to FDA to Establish and Maintain the GUDID
    The estimated present value over 10 years of the costs to FDA to 
establish and maintain the GUDID would be $13.7 million at a 7 percent 
discount rate and $16.1 million at 3 percent. The annualized costs over 
10 years would be $1.8 million at 7 percent and 3 percent.
4. Costs to Foreign Labelers
    We lack sufficient information to quantify the potential impact of 
the proposed rule on foreign establishments and thus exclude these 
establishments from our cost estimate. However, we include a 
qualitative discussion of the potential impact of this rule on trade 
and the cost of imported products, whose value is about one-fourth the 
value of domestic production. We request comment from affected 
industries about their expected compliance costs and responses to the 
proposed rule.
5. Uncertainty
    In this analysis, the lower and upper bounds of uncertainty 
surrounding the central estimate of the costs to domestic labelers are 
about 50 percent lower and 50 percent higher, respectively. Applying a 
similar range of uncertainty to the total costs of the proposed rule to 
domestic labelers, issuing agencies, and the FDA, over 10 years the 
total annualized domestic costs would range from $34.9 million to 
$101.8 million at 7 percent and $34.1 million to $99.7 million at 3 
percent.
6. Alternatives
    The Agency analyzed a number of alternatives with varied 
requirements affecting the coverage of devices, the content of the 
information required to be encoded in a UDI, and specific provisions of 
the proposed rule. With respect to device coverage, we analyzed 
applying the UDI requirements to class III devices only, and to class 
II and III devices only. The Agency also analyzed costs for requiring 
the UDI to contain only the device identifier across all device 
classes. Also included was an alternative that required a UDI labeling 
change without requiring the submission of data to the GUDID.
    Over 10 years at 7 percent, the annualized present value of the 
highest cost alternative is about $95 million. This alternative would 
apply the UDI requirements to class I, II and III devices, as well as 
unclassified devices, unless excepted by proposed 801.30(a)(3)-(12). 
The lowest cost alternative would apply the UDI requirements to class 
III devices only. The annualized present value of this alternative is 
about $11 million.

B. Summary of Regulatory Flexibility Analysis

    FDA conducted a regulatory flexibility analysis of the impact of 
the proposed rule on small entities. Ninety-six percent of the 4,693 
affected labeler firms (i.e., 4,483 firms) are small according to Small 
Business Administration (SBA) size standards. Costs of compliance for 
domestic labelers as a percentage of revenues exceed 1 percent for 
about 32 firms with fewer than 19 employees that label devices subject 
to the direct marking requirements. Moreover, for an estimated 8 firms 
with fewer than 5 employees, the burden of the proposed rule would 
represent about 8 percent of their average revenues. If direct marking 
of devices were not required, no firms would experience costs exceeding 
1 percent of revenues.

C. Summary of Benefits

    The proposed rule would standardize how medical devices are 
identified and would contribute to future potential public health 
benefits from initiatives associated with the increased use of 
automated systems in healthcare. Most of these benefits, however, 
require complementary developments and innovations in the private and 
public sectors, and investments by the healthcare industry that are 
beyond the scope of this rule. Because such actions are uncertain, we 
restrict our discussion of the potential public health benefits to 
those most likely to occur as results of probable responses to the 
proposed rule in the private and public sectors.
    The public health benefits from the UDI would be related to 
reductions in medical device-related patient injuries and deaths. More 
accurate and prompt identification of problems would enable more rapid 
action to reduce the incidence of the adverse events. Public health 
safety alerts, for example, could be more accurate and timely. Recall 
actions could more effectively target the problem device. The increased 
accuracy of adverse medical device reporting and improved recalls 
should reduce the total number of adverse medical device events, 
although we are unable to quantify that reduction.
    FDA presents the required ROCIS accounting information in table 4 
of this document.
BILLING CODE 4160-01-P

[[Page 40762]]

[GRAPHIC] [TIFF OMITTED] TP10JY12.027

BILLING CODE 4160-01-C
    The full discussion of the economic impacts (Ref. 10) is available 
in docket FDA-2011-N-0090 and at http://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/default.htm.

V. Information Collection Requirements

    This proposed rule contains information collections that are 
subject to review by OMB under the Paperwork Reduction Act of 1995 (44 
U.S.C. 3501-3520) (the PRA). A description of these provisions is given 
below with an estimate of the reporting, recordkeeping, and third party 
disclosure burden. It should be noted that the burden assumptions for 
some of these requirements reflect one possible manner of compliance, 
and have only been identified for the purposes of estimating the PRA 
burden.

[[Page 40763]]

    FDA invites comments on the following topics: (1) Whether the 
proposed collection of information is necessary for the proper 
performance of FDA's functions, including whether the information will 
have practical utility; (2) the accuracy of FDA's estimate of the 
burden of the proposed collection of information, including the 
validity of the methodology and assumptions used; (3) ways to enhance 
the quality, utility, and clarity of the information to be collected; 
and (4) ways to minimize the burden of the collection of information on 
respondents, including through the use of automated collection 
techniques, when appropriate, and other forms of information 
technology.
    Description of Respondents: The recordkeeping, reporting, and 
third-party disclosure requirements referenced below are imposed on any 
person who causes a label to be applied to a device, or who causes the 
label to be modified, with the intent that the device will be 
introduced into interstate commerce without any subsequent replacement 
or modification of the label. In most instances, the labeler would be 
the device manufacturer, but the labeler may be a specification 
developer, a single-use device reprocessor, a convenience kit 
assembler, a repackager, or a relabeler. Respondents may also include 
any private nonprofit organization or State agency that applies for 
accreditation by FDA as an issuing agency.
    Requirements Reflected in the Burden Estimates: FDA has identified 
the following requirements as having burdens that must be accounted for 
under the PRA; the burdens associated with these requirements are 
summarized in the tables that follow:

    (1) Proposed Sec.  801.18 Format of dates provided on a medical 
device label.
    (2) Proposed Sec.  801.20 Label to bear a unique device 
identifier.
    (3) Proposed Sec.  801.35 Request for an exception from or 
alternative to the requirement for the label of a device to bear a 
unique device identifier.
    (4) Proposed Sec.  801.40 Voluntary labeling of a device with a 
unique device identifier.
    (5) Proposed Sec.  801.50 Devices that must be directly marked 
with a unique device identifier.
    (6) Proposed Sec.  830.60 Relabeling or modification of the 
label of a device that bears a UDI.
    (7) Proposed Sec.  830.110 Application for and renewal of 
accreditation as an issuing agency.
    (8) Proposed Sec.  830.120 Responsibilities of an issuing 
agency.
    (9) Proposed Sec.  830.310 Information required for unique 
device identification.
    (10) Proposed Sec.  830.320 Submission of unique device 
identification information (Waivers).
    (11) Proposed Sec.  830.350 Records to be maintained by the 
labeler.
    (12) Proposed conforming amendments to Part 803--Medical Device 
Reporting
    (13) Proposed conforming amendments to Part 806--Reports of 
Corrections and Removals.
    (14) Proposed conforming amendments to Part 814--Premarket 
Approval of Medical Devices
    (15) Proposed conforming amendments to Part 820--Quality System 
Regulation
    (16) Proposed conforming amendments to Part 821--Medical Device 
Tracking Requirements
    (17) Proposed conforming amendments to Part 822 --Postmarket 
Surveillance

                                                         Table 5--1st Year Estimated Burdens \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                    Number of       Number of
                                                   respondents    responses per   Total annual    Average burden per response (in hours)    Total hours
                                                       \2\       respondent \3\   responses \4\                    \5\                          \6\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Reporting......................................             372             102          37,938  0.070                                             2,662
                                                                                                 [4 minutes]
Recordkeeping..................................             366             371         135,652  0.081                                            11,055
                                                                                                 [5 minutes]
Third-Party Disclosure (UDI)...................             359           5,304       1,905,303  0.012                                            23,790
                                                                                                 [1 minute]
Third-Party Disclosure (Date Format)...........           6,199             102         632,298  1.000                                           632,298
                                                                                                 [60 minutes]
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ Table 5 shows the burden to labelers affected in the first year.
\2\ Maximum No. of Respondents for any regulatory requirement within each category. Individual regulatory requirements within the category may involve
  fewer respondents.
\3\ Maximum No. of Responses for any regulatory requirement within each category. Individual regulatory requirements within the category may involve
  fewer responses.
\4\ Maximum Total Annual Responses for any regulatory requirement within each category. IndivIdual regulatory requirements within the category may
  involve fewer total annual responses.
\5\ Rounded to three decimals. Total Hours reflects a more precise, non-rounded Average Burden per Response. An approximate (non-rounded) conversion to
  minutes is shown in square brackets.
\6\ Total Hours is based on a more precise Burden per Response than the rounded value shown in these tables.


                                                        Table 6--Ongoing Estimated Annual Burdens
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                    Number of       Number of
                                                   respondents    responses per   Total annual    Average burden per response (in hours)    Total hours
                                                       \1\       respondent \2\   responses \3\                    \4\                          \5\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Reporting......................................           6,199              51         316,149  0.023                                             7,289
                                                                                                 [1 minute]
Recordkeeping..................................           5,987              51         305,337  0.989                                           302,121
                                                                                                 [59 minutes]
Third-Party Disclosure.........................           5,987              51         305,337  0.885                                           270,143
                                                                                                 [53 minutes]
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ Maximum No. of Respondents for any regulatory requirement within each category. Individual regulatory requirements within the category may involve
  fewer respondents.
\2\ Maximum No. of Responses for any regulatory requirement within each category. Individual regulatory requirements within the category may involve
  fewer responses.
\3\ Maximum Total Annual Responses for any regulatory requirement within each category. Individual regulatory requirements within the category may
  involve fewer total annual responses.

[[Page 40764]]

 
\4\ Rounded to three decimals. Total Hours reflects a more precise, non-rounded Average Burden per Response. An approximate (non-rounded) conversion to
  minutes is shown in square brackets.
\5\ Total Hours is based on a more precise Burden per Response than the rounded value shown in these tables.

    In accordance with section 3507(d) of the Paperwork Reduction Act 
of 1995 (44 U.S.C. 3501 et seq.), the information collection or 
recordkeeping requirements included in this proposed rule have been 
submitted for approval to the Office of Management and Budget (OMB). A 
copy of the supporting statement for this information collection will 
be available on the Internet at http://www.reginfo.gov/public/do/PRAMain and will be posted to the docket at http://www.regulations.gov, 
in docket FDA-2011-N-0090 (Ref. 11). Please email comments to the 
Office of Information and Regulatory Affairs, OMB, Attention: Desk 
Officer for FDA, [email protected]. Please send a copy of 
your comments to FDA, using one of the methods described under 
ADDRESSES at the beginning of this document. Interested persons are 
requested to email comments regarding information collection by 
September 10, 2012.

VI. Environmental Impact

    FDA has determined under 21 CFR 25.30(h) that this action is of a 
type that does not individually or cumulatively have a significant 
effect on the human environment. Therefore, neither an environmental 
assessment nor an environmental impact statement is required.

VII. Proposed Effective Dates

    FDA proposes that any final rule based on this proposal become 
effective as summarized in the following table of this document.

                             Table 7--Effective Dates of UDI Regulatory Requirements
----------------------------------------------------------------------------------------------------------------
               Effective date                                             Requirement
----------------------------------------------------------------------------------------------------------------
Immediately upon publication of a final rule  Requests for an exception or alternative to UDI labeling
                                               requirements may be submitted pursuant to Sec.   801.35.
                                              Sec.  Sec.   830.100-830.130 (subpart C of part 830, concerning
                                               accreditation of issuing agencies) and Sec.   830.10
                                               (incorporation by reference of certain standards) go into effect.
                                               This will allow applications for accreditation as an issuing
                                               agency to be submitted to FDA immediately.
One year after publication of a final rule..  Dates on medical device labels must be formatted as required by
                                               Sec.   801.18.
                                              The label and package of class III medical devices and devices
                                               licensed under the Public Health Service Act must bear a UDI.
                                               Sec.   801.20(b)(1).
                                              Data for class III devices and devices licensed under the Public
                                               Health Service Act that are required to be labeled with a UDI
                                               must be submitted to the GUDID database. Sec.   830.300.
Three years after publication of a final      Class III devices required to be labeled with a UDI must bear a
 rule.                                         UDI as a permanent marking on the device itself if the device is
                                               1) an implantable device, 2) a device intended to be used more
                                               than once and intended to be sterilized before each use, or 3)
                                               stand-alone software regulated as a medical device. Sec.
                                               801.50.
                                              The label and package of class II medical devices must bear a UDI.
                                               Sec.   801.20(b)(2).
                                              Data for class II devices that are required to be labeled with a
                                               UDI, must be submitted to the GUDID database. Sec.   830.320.
Five years after publication of a final rule  Class II devices required to be labeled with a UDI must bear a UDI
                                               as a permanent marking on the device itself if the device is 1)
                                               an implantable device, 2) a device intended to be used more than
                                               once and intended to be sterilized before each use, or 3) stand-
                                               alone software regulated as a medical device. Sec.   801.50.
                                              The label and package of class I medical devices and devices that
                                               have not been classified into class I, class II, or class III
                                               must bear a UDI. Sec.   801.20(b)(3), (4).
                                              Data for class I devices and devices that have not been classified
                                               into class I, class II, or class III that are required to be
                                               labeled with a UDI must be submitted to the GUDID database. Sec.
                                                830.320.
Seven years after publication of a final      Class I devices and devices that have not been classified into
 rule.                                         class I, class II, or class III required to be labeled with a UDI
                                               must bear a UDI as a permanent marking on the device itself if
                                               the device is 1) an implantable device, 2) a device intended to
                                               be used more than once and intended to be sterilized before each
                                               use, or 3) stand-alone software regulated as a medical device.
                                               Sec.   801.50.
90 days after publication of a final rule...  All other provisions go into effect, although some will have no
                                               practical effect until other provisions listed in this table go
                                               into effect.
----------------------------------------------------------------------------------------------------------------

VIII. Federalism

    FDA has analyzed this proposed rule in accordance with the 
principles set forth in Executive Order 13132. FDA has determined that 
the proposed rule, if finalized, would not contain policies that would 
have substantial direct effects on the States, on the relationship 
between the National Government and the States, or on the distribution 
of power and responsibilities among the various levels of government. 
Accordingly, the Agency tentatively concludes that the proposed rule 
does not contain policies that have federalism implications as defined 
in the Executive order and, consequently, a federalism summary impact 
statement is not required.

IX. Request for Comments

A. Submission of Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) either electronic or written comments regarding this 
document. It is only necessary to send one set of comments. Identify 
comments with the docket number found in brackets in the heading of 
this document. Received comments may be seen in the Division of Dockets 
Management between 9 a.m. and 4 p.m., Monday through Friday.

B. Specific Questions

    FDA is seeking comment on questions that may affect requirements we 
include in a final rule. You do not need to respond to any of these 
questions in order to submit a comment; you may respond to any, all, or 
none of these questions, and you may submit

[[Page 40765]]

comments on any topic relating to the purposes of this rule, regardless 
of whether a topic is addressed by these questions.
Objectives of the UDI System and Potential Uses of UDIs
    Section I.A of this document discusses the objectives of the UDI 
system and some of the potential uses of UDIs.
    1. Which of the objectives and potential uses identified for the 
UDI system are most important to you? Are there any important 
objectives or uses we have not identified or have not adequately 
discussed? If you consider any objective or use identified here 
inappropriate, unimportant, or unconvincing, please identify the 
objective or use and explain your views.
Implementation of the UDI System--Effective Dates
    The proposed rule phases in its requirements over several years; 
see table 7 of this document for a summary of the effective dates.
    2. Do the proposed effective dates provide adequate time to prepare 
to meet the rule's requirements? If you believe a particular effective 
date does not provide adequate time to prepare to meet one or more of 
the rule's requirements, please identify the requirement, provide an 
explanation of the difficulties you foresee in meeting the requirement, 
and provide a suggested effective date that would provide adequate time 
to prepare to meet the requirement.
    The proposed effective date for the requirement to provide dates on 
medical devices that conform to a specific format, is 1 year after the 
publication of the final rule. Not all device labels would require date 
format changes.
    3. Will the 1-year effective date result less efficient planning as 
compared to a later date? Taking into account the effective dates for 
the other requirements of the proposed rule, what should be the 
effective date for the formatted date requirement and why?
UDI Labeling Requirements
    The proposed rule would require the label of each medical device 
and device package to bear a UDI, except where an exception is 
available or FDA has authorized an alternative; see proposed Sec.  
801.20. The rule would further require that every UDI be provided in 
two forms: an easily-readable plain-text form and through inclusion of 
AIDC technology (e.g., a bar code, RFID tag, or any other technology) 
that conveys the equivalent of the UDI; see proposed Sec.  801.45.
    4. Is the requirement for a plain-text UDI clear? If you believe 
the requirement for a plain-text UDI would require changes to your 
labeling processes that are substantially different from those required 
for other types of labeling changes that you routinely make, please 
describe the changes you would have to make and provide an estimate of 
the cost of those changes.
    5. Is the requirement for an AIDC technology clear? What type of 
AIDC technology do you expect to use? If you believe the requirement 
for AIDC would require changes to your manufacturing, labeling, or 
packaging processes that are substantially different from those 
required for other types of labeling changes that you routinely make, 
please describe the changes you would have to make and provide an 
estimate of the cost of those changes.
Combination Products
    We propose to require a UDI for every combination product for which 
the primary mode of action is that of a device. See proposed Sec.  
801.25(a). Furthermore, we propose to require a UDI for each device 
constituent part of a combination product, regardless of whether a UDI 
is required for the combination product, except for a device 
constituent part that is physically, chemically, or otherwise combined 
with other constituents of a combination product in such a way that it 
is not possible for the device constituent part to be used except as 
part of the use of the combination product. See proposed Sec.  
801.25(b).
    6. If a combination product's primary mode of action is that of a 
device, is it appropriate to require each device constituent part of 
the combination product to bear its own UDI?
    7. If a combination product's primary mode of action is not that of 
a device, is it appropriate to require each device constituent part of 
the combination product to bear its own UDI?
UDI Labeling of Certain Combination Products That are Not Labeled With 
an NDC
    Proposed Sec.  801.25(a) would require a UDI on the label and 
device package of every combination product whose primary mode of 
action is that of the device. A combination product whose primary mode 
of action is that of the drug or biologic would not be subject to this 
requirement, but would be subject to drug and biologic labeling 
requirements. Many, but not all, drugs and biologics must include a 
barcode on the product's label. See 21 CFR 201.25. The barcode must 
contain, at a minimum, the appropriate NDC. See 21 CFR 201.25. FDA has 
also proposed a rule that would require an NDC in human readable form 
on the label of certain drugs and biologics. See 71 FR 51276, August 
29, 2006. When an NDC is present, FDA intends to make it possible to 
determine whether the combination product has a device constituent part 
and, if so, the identity of each device constituent part. However, if a 
combination product has a primary mode of action of a drug or biologic 
but is not required to include an NDC, there will be a gap in the 
medical community's ability to easily and accurately identify any 
devices within a combination product without opening the package and 
examining its contents; device constituent parts within this labeling 
gap will not be subject to the same benefits this rule offers for other 
devices.
    We may be able to fill this labeling gap by requiring a UDI for 
every combination product that has a device constituent part, 
regardless of its primary mode of action, except when:
     The primary mode of action is not that of a device, and
     The combination product is labeled with an NDC.

Only in those circumstances would a UDI not be required on the label 
and package of the combination product. Such a provision would ensure 
that there is always either an NDC or a UDI on every combination 
product, and would facilitate the identification of those combination 
products that would otherwise not be labeled with either an NDC or UDI 
identifier. This alternative would not interfere with any future FDA 
initiative to require NDCs on any combination product (because, if a 
product bears an NDC, the alternative provision would not require a UDI 
on the combination product).
    8. Should FDA require a UDI on the label and package of every 
combination product that has a device constituent part, regardless of 
its primary mode of action, except when the primary mode of action is 
not that of a device, and the combination product is labeled with an 
NDC?
Convenience Kits
    We propose to require a UDI on each convenience kit and each device 
in a convenience kit, except for single use devices. The reason for 
requiring a UDI on each device in a convenience kit is that such 
devices often become separated from the convenience kit, and are then 
put to use. Some convenience kits, such as a basic first aid kit, may 
include devices that do bear a UDI because of the exception of proposed 
Sec.  801.30(a)(11); that exception would

[[Page 40766]]

exempt a device packaged in a convenience kit from our UDI labeling 
requirements if that device is intended for a single use.
    9. Is it necessary to require a UDI for each device included in a 
convenience kit?
    10. Would it be appropriate to provide an additional exception from 
UDI labeling for any class I device included in a convenience kit, even 
if intended for more than just one single use?
    11. Instead of requiring a UDI on the label of each device included 
in a convenience kit, would it be more appropriate to require the label 
of the convenience kit to identify each device included in the kit, 
together with the UDI of each such device (this would include the UDI 
of a device that does not bear a UDI because of the exception of 
proposed Sec.  801.30(a)(11)?
Direct Marking
    We propose to require certain medical devices to bear a UDI as a 
``direct marking'' on the device. The devices that would be subject to 
this requirement are: (1) An implantable device; (2) a device that is 
intended for more than one use, and that is intended to be sterilized 
before each use; and (3) stand-alone software. We provide alternatives 
to direct marking in proposed Sec.  801.50(e) and exceptions in Sec.  
801.50(f).
    Direct marking will help ensure the accurate identification of the 
device, even if separated from its label and labeling. We would not 
require direct part marking of all devices, because we believe the 
costs and challenges of such an approach substantially exceed the 
potential benefit to the UDI system.
    12. Is it appropriate to require direct marking for all implantable 
devices? Should the requirement be limited to certain types of 
implants? If so, how should we define which implantable devices meet 
that requirement?
    13. Is it appropriate to require direct marking for all devices 
intended for more than one use that require sterilization before each 
use? Are there good reasons to require direct marking for all devices 
intended for more than one use, regardless of whether the device must 
be sterilized before each use?
    14. The proposed rule would require direct marking of stand-alone 
software devices, but does not define ``stand-alone software.'' The 
exception provided by proposed Sec.  801.50(e)(6) makes it clear that 
``stand-alone software'' does not include software that is ``a 
component of a medical device.'' Because the term ``component'' has 
been in common use for many years, FDA believes that the medical device 
industry has an adequate understanding of when software is stand-alone 
software that is itself a medical device and when software is only a 
component of a medical device.
    Does the ``component'' distinction provide enough clarity for you 
to understand when software is stand-alone software that requires 
direct marking? If not, please suggest how FDA could define ``stand-
alone software'' so that it would be clear when software must be 
directly marked.
    15. Are there other types of devices that you believe would benefit 
from direct marking? If you were to prioritize the need for direct 
marking of different types of devices, what devices are most in need of 
direct marking to ensure their adequate identification through 
distribution and use? What attributes do these devices have in common 
that makes direct marking important?
UDI Labeling Exceptions and Alternatives
    Proposed Sec.  801.30 provides categorical exceptions to the 
requirement for a device to bear a UDI, and proposed Sec.  801.35 
provides for case-by-case exceptions and alternatives to the UDI 
regulatory system. Procedures for requesting an exception or 
alternative are provided at proposed Sec.  801.35(a).
    16. Are any of the categorical exceptions provided by proposed 
Sec.  801.30 inappropriate? If so, identify the exception and explain 
why you believe the exception is inappropriate.
    17. Are there any additional categorical exceptions that you 
believe would be appropriate? Please explain.
    18. Under the exception provided by proposed Sec.  801.30(a)(1), a 
class I device that FDA has exempted from our GMP requirements would 
not be required to bear a UDI. To help reviewers understand the scope 
of this exception, we have provided a list of class I devices, by 
product code, that currently would qualify for this exception; see Ref. 
9. Our questions regarding this exception are: 18.1. Is this 
exception--for class I devices that are exempt from GMP requirements--
appropriate? 18.2. Referring to the devices listed in reference 10, are 
there any devices for which this exception is not appropriate and which 
should be required to bear a UDI? 18.3. Are there other class I devices 
that are exempt from GMP requirements that do not appear to have been 
identified in the reference 10 list?
    19. Class I devices are very diverse, and include devices available 
only at retail, basic but critical dental and surgical instruments and 
medical equipment, and products used in testing and diagnosis. Under 
proposed 801.30(c), we propose to except all of these devices from the 
proposed requirement that their labels bear a production identifier. 
Many of these class I devices are also subject to other proposed 
exceptions. For example, devices, including class 1 devices sold at 
retail like dental floss, menstrual pads, hot/cold compresses, adhesive 
bandages, reading glasses, and sunglasses are exempt under proposed 21 
CFR 801.30(a)(1). Although Class I devices are generally low risk or 
very well understood devices, we note the class includes devices that 
have been recalled or the subject of serious patient safety concerns. 
For such devices, the benefit of requiring that their labels bear 
device identifiers likely outweighs the cost savings of excepting such 
devices entirely from UDI. FDA is soliciting comment on: (1) whether 
additional class I devices, additional categories of class I devices, 
or all class I devices should be granted exceptions from device 
identifier requirements; and (2) whether any class I devices covered by 
the proposed rule should be subject to the requirement that their 
labels bear a production identifier.
    20. Does the procedure in proposed Sec.  801.35(a) provide a 
reasonable basis for accommodating requests for exceptions from, or 
alternatives to, the general rule for UDI labeling?
Form of a Unique Device Identifier
    We propose to require use of AIDC technology whenever a device is 
labeled with a UDI. We do not specify what technology may be used. Our 
intent is to allow for the advancement of such technologies, leaving 
the decision to the healthcare community and issuing agencies. When the 
AIDC technology is not visible on the label or package (e.g., an RFID 
tag or near-field communication), the label would have to include a 
symbol that provides notice of the presence of the AIDC technology.
    21. Should FDA require the use of specific AIDC technologies or 
have a role in approving the use of new AIDC technologies that are used 
to provide a UDI, or should we leave this decision to the healthcare 
community and issuing agencies?
    22. We propose to permit use of a generic symbol to provide notice 
of the presence of AIDC technology that provides a UDI:
[GRAPHIC] [TIFF OMITTED] TP10JY12.010


[[Page 40767]]


    Should we restrict this provision to allow use of the generic 
symbol only when there is no symbol endorsed in an international 
standard, and no symbol generally recognized by the persons who 
typically use the device? For example, there are recognized symbols for 
RFID and NFC technologies; should we require use of one of those 
recognized symbols when that form of AIDC technology is used?
Roles of the Issuing Agency
    We are proposing a system that would permit multiple issuing 
agencies to offer differing UDI systems, so long as each system meets 
our UDI system requirements (see proposed Sec.  801.45, Form of a UDI, 
and proposed Sec.  830.20, Requirements for a unique device 
identifier). This is intended to allow for competition, which may have 
benefits, both in terms of UDI system features and the costs to device 
labelers.
    23. Do the accreditation requirements outlined in proposed Sec.  
830.100 provide sufficient opportunity for interested and qualified 
organizations to be accredited as an issuing agency?
    24. Will the existence of multiple UDI systems confuse device user 
facilities or impose unreasonable costs on device user facilities?
    25. Would it be preferable for FDA to accredit only one national 
issuing agency, through careful evaluation of the strengths and 
weaknesses of alternative systems, through a competitive contract or 
some other means? If you believe a single national issuing agency would 
be preferable, please explain your views and explain how FDA should 
make such a designation, including neutral criteria that FDA should 
apply when evaluating possible candidates.
    We are proposing to require an issuing agency to be either a 
private nonprofit organization or a State agency. The reason for this 
is to minimize potential conflicts of interest and to help assure that 
the fees assessed by an issuing agency are reasonable to small 
businesses.
    26. Are there compelling reasons to permit a for-profit 
organization to be accredited as an issuing agency?
Data Submission Requirements and the GUDID
    Proposed Sec.  830.330 would require each device labeler to 
designate a contact who would be responsible for providing FDA with 
information relating to the identification of the labeler's medical 
devices. For each device labeled with a UDI, the contact would have to 
provide information concerning the labeler and each version or model of 
a device labeled with a UDI.
    27. If you believe any of the information that would be required by 
proposed Sec.  830.330 is not necessary to assure the adequate 
identification of a medical device, please identify the information you 
believe is unnecessary and provide an explanation of your views.
    28. If you believe that additional information should be required 
to assure the adequate identification of a medical device, please 
identify the information you believe is necessary and provide an 
explanation of your views. Some additional attributes that have been 
suggested are:
    a. Prescription and/or over-the-counter;
    b. Magnetic Resonance Imaging (MRI) Compatibility Type (safe, 
unsafe, conditional); if conditional, the description of the 
conditions;
    c. Storage and handling conditions (e.g., maximum storage 
temperature, needs to be refrigerated, keep out of light);
    d. Country of origin, manufacturer, and/or intended sale
    e. Short and/or long descriptions
    f. Marketed for home use
    g. Labeled as hazardous
    h. Contains radioactive isotopes (radioactive element and atomic 
number)
    i. Has Material Safety Data Sheet (MSDS)--MSDS Hyperlink
    Please provide your views on the need for each of these additional 
attributes. If you believe an attribute would be useful, should it be 
part of our mandatory reporting requirements (proposed Sec.  830.310), 
or should it be collected on a voluntary basis as ancillary information 
(proposed Sec.  830.340)?
    We are proposing to require submission of UDI data no later than 
the date the label of the device must bear a UDI. See proposed Sec.  
830.330. We believe that the availability and speed of Internet 
connections makes any delay unnecessary and counterproductive.
    29. If you believe that it is unreasonable to tie submission of UDI 
data to the date the label of the device must bear a UDI, please 
suggest an alternative time frame and provide an explanation of why the 
delay in submission of information is necessary.
    Our proposed rule does not specify the process for the electronic 
submission of information to the GUDID. Instead, we plan to explain the 
submission process in guidance. Our current thinking is that we would 
provide two ways to submit data to the GUDID:
     Data could submitted as part of a structured product label 
(SPL) conforming to an ANSI/Health Level Seven (HL7) format (Ref. 7) 
that meets specifications set by FDA; we believe this is the approach 
most larger labelers would prefer, as it is based on an existing 
international standard that is already used for submission of data to 
FDA, and can readily accommodate the efficient submission of multiple 
records.
     Each data element could be entered directly into the GUDID 
through a secure Internet site designed for simple, low-volume data 
entry with on-line help, similar to the approach currently used for 
electronic registration and listing; we believe this approach may be 
preferred by some small labelers that would need to provide data for 
only a few devices.
    30. Do these two approaches for data submission provide sufficient 
options for submitting data to the GUDID? If you are a labeler, which 
approach would you expect to use? If you expect to use both, please 
discuss the circumstances that would lead you to use one or the other 
approach.
    31. What information would FDA need to provide in its guidance on 
submitting data to the GUDID? What questions would you want to see 
asked and answered in the guidance?
Format of Dates Provided on Medical Device Labels
    Proposed Sec.  801.18 would require all dates provided on medical 
device labels to conform to a specified format: Month Day, Year, with 
the month shown as a three-letter abbreviation of the month (e.g. SEP 
30, 2011). This is the format most commonly used in the United States. 
But internationally, a different format--Day Month Year (30 SEP 2011)--
is more prevalent.
    32. Will a specified format for dates on medical device labels 
reduce confusion concerning expiration dates?
    33. Which format would patients better understand, the ``U.S.'' 
format (e.g., SEP 30, 2011), or the ``international'' format (e.g., 30 
SEP 2011)?
    34. Which format would health care professionals better understand, 
the ``U.S.'' format (e.g., SEP 30, 2011), or the ``international'' 
format (e.g., 30 SEP 2011)?
    35. Is there a strong reason to favor one format over the other?

X. References

    The following references have been placed on display in the 
Division of Dockets Management (see ADDRESSES) and may be seen by 
interested persons between 9 a.m. and 4 p.m., Monday

[[Page 40768]]

through Friday. (FDA has verified the Web site addresses, but FDA is 
not responsible for any subsequent changes to the Web sites after this 
document publishes in the Federal Register).

1. See referenced ISO standards and ISO Technical Committees listed 
at http://www.iso.org/iso/standards_development/technical_committees/list_of_iso_technical_committees/iso_technical_committee.htm?commid=45332.
2. For information about UPC and other barcodes and GS1, go to 
http://www.gs1us.org/standards/barcodes.
3. ``The Health Industry Bar Code (HIBC) Supplier Labeling 
Standard,'' ANSI/HIBC 2.3-2009, Health Industry Business 
Communications Council, 2009, at  http://www.hibcc.org/AUTOIDUPN/ANSI%20HIBC%202.3%20SLS%202009.pdf.
4. ``Automatic Identification of Medical Devices,'' ECRI Institute, 
August 17, 2005.
5. See record and public comments related to the October 25, 2006, 
and February 12, 2009, public meetings, referenced at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/UniqueDeviceIdentification/.
6. See ERG's 2006 report at  http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/UniqueDeviceIdentification/ucm054169.htm.
7. See discussion of HL7 implementation of SPL model for medical 
product information at  http://wiki.hl7.org/index.php?title=Medical_Product_Information_(SPLr5).
8. Letter from Michael D. Maves, MD, MBA, Executive Vice President 
and CEO, American Medical Association, regarding confusion caused by 
inconsistencies in the presentation of expiration dates on medical 
devices, August 27, 2008.
9. List of class I devices, by product code, that FDA has by 
regulation exempted from the GMP requirements of 21 CFR part 820, 
Quality Systems Regulation, FDA, April 2012.
10. Unique Device Identification System; Proposed Rule: Preliminary 
Regulatory Impact Analysis; Initial Regulatory Flexibility Analysis; 
Unfunded Mandates Reform Act Analysis.
11. Supporting Statement for Unique Device Identification (UDI) 
System, 21 CFR Parts 16, 801, 803, 806, 810, 814, 820, 821, 822, and 
830, OMB No. 0910-NEW.

List of Subjects

21 CFR Part 16

    Administrative practice and procedure.

21 CFR Part 801

    Labeling, Medical devices, Reporting and recordkeeping 
requirements.

21 CFR Parts 803, 806, and 821

    Imports, Medical devices, Reporting and recordkeeping requirements.

21 CFR Part 810

    Administrative practice and procedure, Medical devices, Reporting 
and recordkeeping requirements.

21 CFR Part 814

    Administrative practice and procedure, Confidential business 
information, Medical devices, Medical research, Reporting and 
recordkeeping requirements.

21 CFR Parts 820 and 822

    Medical devices, Reporting and recordkeeping requirements.

21 CFR Part 830

    Administrative practice and procedure, Labeling, Medical devices, 
Reporting and recordkeeping requirements.

    Therefore, under the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 321 et seq., as amended) and under authority delegated to the 
Commissioner of Food and Drugs, it is proposed that chapter I of title 
21 be amended to read as follows:

PART 16--REGULATORY HEARING BEFORE THE FOOD AND DRUG ADMINISTRATION

    1. The authority citation for part 16 continues to read as follows:

    Authority: 15 U.S.C. 1451-1461; 21 U.S.C. 141-149, 321-394, 
467f, 679, 821, 1034; 28 U.S.C. 2112; 42 U.S.C. 201-262, 263b, 364.

    2. Amend Sec.  16.1(b)(2) by numerically adding an entry for 
``Sec.  830.130'' to read as follows:


Sec.  16.1  Scope.

* * * * *
    (b) * * *
    (2) * * *
    Sec.  830.130, relating to suspension or revocation of the 
accreditation of an issuing agency.
* * * * *

PART 801--LABELING

    3. The authority citation for part 801 continues to read as 
follows:

    Authority: 21 U.S.C. 321, 331, 351, 352, 360i, 360j, 371, 374.

Subpart A--[Amended]

    4. Amend subpart A of part 801 by adding Sec.  801.3 to read as 
follows:


Sec.  801.3  Definitions.

    Automatic identification and data capture (AIDC) means any 
technology that conveys the unique device identifier (UDI) or the 
device identifier of a device in a form that can be entered into an 
electronic patient record or other computer system via an automated 
process.
    Center Director means the Director of the Center for Devices and 
Radiological Health or the Director of the Center for Biologics 
Evaluation and Research, depending on which Center has been assigned 
lead responsibility for the device.
    Combination product has the meaning set forth in Sec.  3.2(e) of 
this chapter.
    Convenience kit means two or more different types of medical 
devices packaged together for the convenience of the user.
    Device package means a package that contains a fixed quantity of 
devices.
    Expiration date means the date by which the label of a device 
states the device must or should be used.
    Finished device means any device or accessory to any device that is 
suitable for use or capable of functioning.
    FDA, we, or us means the Food and Drug Administration.
    Global Unique Device Identification Database (GUDID) means the 
database that serves as a repository of information about devices to 
facilitate the identification of medical devices through their 
distribution and use.
    Implantable device means a device that is intended to be placed in 
a surgically or naturally formed cavity of the human body. A device is 
regarded as an implantable device for the purpose of this part only if 
it is intended to remain implanted continuously for a period of 30 days 
or more, unless the Commissioner of Food and Drugs determines otherwise 
in order to protect human health.
    Label has the meaning set forth in section 201(k) of the Federal 
Food, Drug, and Cosmetic Act.
    Labeler means:
    (1) Any person who causes a label to be applied to a device with 
the intent that the device will be introduced into interstate commerce 
without any intended subsequent replacement or modification of the 
label; and
    (2) Any person who causes the label of a device to be modified with 
the intent that the device will be introduced into interstate commerce 
without any subsequent replacement or modification of the label, except 
that the addition of the name of, and contact information for, a person 
who distributes the device, without making any other changes to the 
label, is not a modification for the purposes of determining whether a 
person is a labeler.
    Lot or batch means one finished device or more that consists of a 
single type, model, class, size, composition, or software version that 
is manufactured under essentially the same conditions

[[Page 40769]]

and that are intended to have uniform characteristics and quality 
within specified limits.
    Shipping container means a package, container, or pallet used 
during the shipment or transportation of devices from one point to 
another, and whose contents may vary from one shipment to another.
    Specification means any requirement with which a device must 
conform.
    Unique device identifier (UDI) means an identifier that adequately 
identifies a device through its distribution and use by meeting the 
requirements of Sec.  830.20 of this chapter. A unique device 
identifier is composed of:
    (1) A device identifier--a mandatory, fixed portion of a UDI that 
identifies the specific version or model of a device and the labeler of 
that device; and
    (2) A production identifier--a conditional, variable portion of a 
UDI that identifies one or more of the following when included on the 
label of the device:
    (i) The lot or batch within which a device was manufactured;
    (ii) The serial number of a specific device;
    (iii) The expiration date of a specific device;
    (iv) The date a specific device was manufactured.
    Universal product code (UPC) means the product identifier used to 
identify a company and product name of an item sold at retail in the 
United States.
    Version or model means a device package containing one or more 
devices that have identical specifications, performance, size, and 
composition, within specified limits.
    4a. Amend subpart A of part 801 by adding Sec.  801.18 to read as 
follows:


Sec.  801.18  Format of dates provided on a medical device label.

    (a) Whenever the label of a medical device includes an expiration 
date, a date of manufacture, or any other date intended to be brought 
to the attention of the user of the device, the date shall be presented 
in the following format: Month Day, Year (e.g., JAN 1, 2012).
    (b) All dates must include a day; a date composed only of a month 
and year does not meet the requirements of this section.
    (c) The month shall be shown as a three-letter abbreviation of the 
name of the month, presented in capital letters as follows:

------------------------------------------------------------------------
                 Month                             Abbreviation
------------------------------------------------------------------------
January................................  JAN.
February...............................  FEB.
March..................................  MAR.
April..................................  APR.
May....................................  MAY.
June...................................  JUN.
July...................................  JUL.
August.................................  AUG.
September..............................  SEP.
October................................  OCT.
November...............................  NOV.
December...............................  DEC.
------------------------------------------------------------------------

    (d) The day shall be shown in modern Arabic numerals, with no 
leading zeros (e.g., 1, 2, 3, * * * 29, 30, 31).
    (e) The year shall be shown in modern Arabic numerals, using the 
civil calendar in use in the United States, using four digits (e.g., 
2012).
    (f) The following is an exception for date of manufacture of an 
electronic product to which a standard is applicable under subchapter 
J, Radiological Health: If the device is an electronic product to which 
a standard is applicable under subchapter J, Radiological Health of 
this chapter, the date of manufacture shall be presented as required by 
Sec.  1010.3(a)(2)(ii) of this chapter.
    5. Add subpart B consisting of Sec. Sec.  801.20 to 801.57 to read 
as follows:
Subpart B--Labeling Requirements for Unique Device Identification
Sec.
801.20 Label to bear a unique device identifier (UDI).
801.25 Unique device identifiers for combination products, device 
constituents parts of a combination product, convenience kits, and 
devices packaged in a convenience kit.
801.30 General exceptions from the requirement for the label of a 
device to bear a unique device identifier.
801.35 Request for an exception from or alternative to the 
requirement for a device to bear a unique device identifier.
801.40 Voluntary labeling of a device with a unique device 
identifier.
801.45 Form of a unique device identifier.
801.50 Devices that must be directly marked with a unique device 
identifier.
801.57 Discontinuation of legacy FDA identification numbers assigned 
to devices.

Subpart B--Labeling Requirements for Unique Device Identification


Sec.  801.20  Label to bear a unique device identifier (UDI).

    (a) In general:
    (1) The label of every medical device shall bear a unique device 
identifier (UDI) that meets the requirements of this subpart and part 
830.
    (2) Every device package shall bear a UDI that meets the 
requirements of this subpart and part 830.
    (b) Effective dates. The requirements of paragraph (a) of this 
section become effective:
    (1) If the device is a class III medical device or is a device 
licensed under the Public Health Service Act, [A DATE WILL BE ADDED 1 
YEAR AFTER DATE OF PUBLICATION OF THE FINAL RULE IN THE FEDERAL 
REGISTER];
    (2) If the device is a class II medical device, [A DATE WILL BE 
ADDED 3 YEARS AFTER DATE OF PUBLICATION OF THE FINAL RULE IN THE 
FEDERAL REGISTER];
    (3) If the device is a class I medical device, [A DATE WILL BE 
ADDED 5 YEARS AFTER DATE OF PUBLICATION OF THE FINAL RULE IN THE 
FEDERAL REGISTER];
    (4) If the device is not classified into class I, II, or III, 
[specific date, 5 years after publication of a final rule].
    (c) Exceptions. Exceptions to the general rule of paragraph (a) of 
this section are provided by Sec. Sec.  801.30, 801.35, and 
801.128(f)(2).


Sec.  801.25  Unique device identifiers for combination products, 
device constituent parts of a combination product, convenience kits, 
and devices packaged in a convenience kit.

    (a) Application to combination products. The label and each device 
package of every combination product for which the primary mode of 
action is that of a device shall bear a unique device identifier (UDI) 
as provided by Sec.  801.20. The requirements of Sec.  801.20 become 
effective on the earlier of:
    (1) If FDA has classified the combination product under a medical 
device classification regulation or other classification action, the 
date that applies to such classification under Sec.  801.20(b); or
    (2) The earliest date that applies under Sec.  801.20(b) to any 
device constituent part of the combination product.
    (b) Device constituent parts of a combination product. The label 
and each device package of each device constituent part of a 
combination product shall bear its own unique device identifier (UDI), 
distinct from any UDI assigned to the combination product, and 
regardless of whether the combination product is required to have a 
UDI, except that a UDI is not required for a device constituent part 
that is physically, chemically, or otherwise combined with other 
constituents of a combination product in such a way that it is not 
possible for the device constituent part to be used except as part of 
the use of the combination product.
    (c) Application to convenience kits. The label and each device 
package of every convenience kit shall bear a UDI as provided by Sec.  
801.20. The

[[Page 40770]]

requirements of Sec.  801.20 become effective with regard to a 
convenience kit on the earlier of:
    (1) If FDA has classified the convenience kit under a medical 
device classification regulation or other classification action, the 
date that applies to such classification under Sec.  801.20(b); or
    (2) The earliest date that applies under Sec.  801.20(b) to any 
device included in the convenience kit.
    (d) Devices included in a convenience kit. The label and each 
device package of each device that is packaged in a convenience kit 
shall bear its own UDI, distinct from that of the convenience kit, 
unless the device is intended for a single use.


Sec.  801.30  General exceptions from the requirement for the label of 
a device to bear a unique device identifier.

    (a) In general. The following types of devices are excepted from 
the requirement of Sec.  801.20; a device within one or more of the 
following exceptions is not required to bear a unique device identifier 
(UDI):
    (1) A device, other than a prescription device, that is made 
available for purchase at a retail establishment. This exception shall 
also apply to such a device when delivered directly to a hospital, 
ambulatory surgical facility, nursing home, outpatient treatment 
facility, or other health care facility.
    (2) A class I device that FDA has by regulation exempted from the 
good manufacturing practice requirements of part 820 of this chapter.
    (3) Individual class I, single-use devices, all of a single version 
or model, that are distributed together in a single device package, 
whose uses are generally known to the persons by whom they are intended 
to be used, and which are not intended for individual sale. The device 
package containing these individual devices is not exempt from the 
requirement of Sec.  801.20, and must bear a UDI.
    (4) A device used solely for research, teaching, or chemical 
analysis, and not intended for any clinical use.
    (5) A custom device within the meaning of Sec.  812.3(b).
    (6) An investigational device within the meaning of part 812.
    (7) A veterinary medical device not intended for use in the 
diagnosis of disease or other conditions in man, in the cure, 
mitigation, treatment, or prevention of disease in man, or intended to 
affect the structure or any function of the body of man.
    (8) A device intended for export from the United States.
    (9) A device held by the Strategic National Stockpile and granted 
an exception or alternative under Sec.  801.128(f)(2).
    (10) A device for which FDA has established a performance standard 
under section 514(b) of the Federal Food, Drug, and Cosmetic Act and 
has provided therein an exception from the requirement of Sec.  801.20, 
or for which FDA has recognized all or part of a performance standard 
under section 514(c) of the Federal Food, Drug, and Cosmetic Act and 
has included an exception from the requirement of Sec.  801.20 within 
the scope of that recognition.
    (11) A device constituent part of a combination product that is 
physically, chemically, or otherwise combined with other constituents 
of the combination product in such a way that it is not possible for 
the device constituent part to be used except as part of the use of the 
combination product.
    (12) A device that is packaged in a convenience kit, provided that 
the device is intended for a single use.
    (b) Exception for shipping containers. This rule does not require a 
unique device identifier to be placed on any shipping container.
    (c) The unique device identifier (UDI) of a class I device is not 
required to include a production identifier.


Sec.  801.35  Request for an exception from or alternative to the 
requirement for a device to bear a unique device identifier.

    (a) A labeler may submit a request for an exception from or 
alternative to the requirement of Sec.  801.20 or any requirement of 
this subpart for a specified device or a specified type of device. A 
written request for an exception or alternative must:
    (1) Identify the device that would be subject to the exception or 
alternative;
    (2) Identify the provisions of this subpart that are the subject of 
the request for an exception or alternative;
    (3) If requesting an exception, explain why you believe the 
requirements of this subpart are not technologically feasible;
    (4) If requesting an alternative, describe the alternative and 
explain why it would provide for more accurate, precise, or rapid 
device identification than the requirements of this subpart or how the 
alternative would better ensure the safety or effectiveness of the 
device that would be subject to the alternative;
    (5) Provide an estimate of the number of labelers and the number of 
devices that would be affected if we grant the requested exception or 
alternative; and
    (6) Provide other requested information that the Center Director 
needs to clarify the scope and effects of the requested exception or 
alternative.
    (b) A request for an exception or alternative under paragraph (a) 
of this section may be submitted as part of a device premarket 
submission.
    (1) FDA may grant a request for an exception or alternative 
submitted as part of an FDA premarket submission within the context of 
our approval or clearance of the device that is the subject of the 
premarket submission.
    (2) FDA will not respond to a request for an exception or 
alternative submitted as part of an FDA premarket submission if we do 
not approve or clear the device that is the subject of the premarket 
submission.
    (c) A written request that is not submitted as part of an FDA 
premarket submission should be submitted to: Division of Small 
Manufacturers, Consumer, and International Assistance (DSMICA), Center 
for Devices and Radiological Health, Bldg. 66, rm. 4621, 10903 New 
Hampshire Ave., Silver Spring, MD 20993.
    (d) The Center Director may grant a request for an exception or 
alternative, either in response to a request or on his or her own 
initiative, if the Center Director determines that an exception is 
appropriate because the requirements of this subpart are not 
technologically feasible, or that an alternative would provide for more 
accurate, precise, or rapid device identification than the requirements 
of this subpart or would better ensure the safety or effectiveness of 
the device that would be subject to the alternative. If we grant an 
exception or alternative, we may include any safeguards or conditions 
deemed appropriate to ensure the adequate identification of the device 
through its distribution and use.


Sec.  801.40  Voluntary labeling of a device with a unique device 
identifier.

    (a) The labeler of a device that is not required to bear a unique 
device identifier (UDI) may voluntarily comply with Sec.  801.20. If a 
labeler voluntarily includes a UDI for a device, the labeler may 
voluntarily provide information concerning the device under subpart E 
of part 830.
    (b) The labeler of a device that is sold at retail may label that 
device with both a Universal Product Code (UPC) and a UDI.


Sec.  801.45  Form of a unique device identifier.

    (a) Every unique device identifier (UDI) must meet the technical 
requirements of Sec.  830.20 of this chapter. The UDI must be presented 
in two forms:
    (1) Easily-readable plain-text, and
    (2) Automatic identification and data capture (AIDC) technology.

[[Page 40771]]

    (b) The UDI must include a device identifier segment. Whenever a 
device is labeled with a lot or batch number, a serial number, a 
manufacturing date, or an expiration date, the UDI must include a 
production identifier segment that conveys such information.
    (c) If the AIDC technology is not evident upon visual examination 
of the label or device package, the label or device package must bear a 
symbol that provides notice of the presence of AIDC technology. The 
symbol may be a symbol approved by the issuing agency, a symbol 
endorsed in a national or international standard recognized by FDA 
under section 514(c) of the FD&C Act and pertaining to the AIDC 
technology, a symbol generally recognized by the persons who typically 
use the device, or the following generic symbol:
[GRAPHIC] [TIFF OMITTED] TP10JY12.011

Sec.  801.50  Devices that must be directly marked with a unique device 
identifier.

    (a) In general. A device that must be labeled with a unique device 
identifier (UDI) must also bear a permanent marking providing the UDI 
on the device itself if the device is:
    (1) An implantable device;
    (2) Intended to be used more than once, and intended to be 
sterilized before each use; or
    (3) Stand-alone software.
    (b) UDI for direct marking. The UDI provided through a direct 
marking on a device may be:
    (1) Identical to the UDI that appears on the label of the device, 
or
    (2) A different UDI used to distinguish the unpackaged device from 
any package containing the device.
    (c) Form of a UDI when provided as a direct marking. When a device 
must bear a UDI as a direct marking, the UDI must be provided in the 
following manner:
    (1) If the device is an implantable device, or the device is 
intended for more than one single use and intended to be sterilized 
before each use, the UDI must be provided through either or both of the 
following:
    (i) Easily-readable plain-text;
    (ii) Automatic identification and data capture (AIDC) technology, 
or any alternative technology, that will provide the UDI of the device 
on demand.
    (2) If the device is stand-alone software, the UDI must be provided 
through either or both of the following:
    (i) An easily-readable plain-text statement displayed whenever the 
software is started;
    (ii) An easily-readable plain-text statement displayed through a 
menu command (e.g., an ``About * * *'' command).
    (d) Effective dates. The requirements of this section apply to a 
device 2 years after the date that applies to the device under Sec.  
801.20.
    (e) Exceptions. The requirement of paragraph (a) of this section 
shall not apply to any device that meets any of the following criteria:
    (1) Direct marking would interfere with the safety or effectiveness 
of the device;
    (2) The device cannot be directly marked because it is not 
technologically feasible;
    (3) The device is intended to remain implanted continuously for a 
period of less than 30 days, unless the Commissioner determines 
otherwise in order to protect human health;
    (4) The device has been previously marked under paragraph (a);
    (5) The device is sold at retail and bears a Universal Product Code 
(UPC);
    (6) Software that is not stand-alone software, but which is a 
component of a medical device.
    (f) Exception to be noted in design history file. If you decide not 
to mark a device after determining that an exception applies under 
paragraph (e) of this section, you must document the basis of your 
decision in the design history file required by Sec.  820.30(j) of this 
chapter of the Quality System Regulation.
    (g) Submission of notice to FDA. If you decide not to mark a device 
after determining that an exception applies under paragraph (e)(1) or 
(e)(2) of this section, you must send a notice to FDA:
    (1) Your notice to FDA must provide the following information:
    (i) Identification of the exception, or exceptions, that you are 
invoking;
    (ii) An explanation of the factors that make the exception 
appropriate for your device;
    (iii) The name of, and contact information for, the person who 
determined that the exception is appropriate for your device.
    (2) Your notice must be submitted to FDA no later than the date you 
begin distribution of the device that is the subject of the notice.
    (3) Your notice should be submitted to: Division of Small 
Manufacturers, Consumer, and International Assistance (DSMICA), Center 
for Devices and Radiological Health, Bldg. 66, rm. 4621, 10903 New 
Hampshire Ave., Silver Spring, MD 20993.


Sec.  801.57  Discontinuation of legacy FDA identification numbers 
assigned to devices.

    On the date your device must be labeled with a unique device 
identifier (UDI), any National Health-Related Item Code (NHRIC) or 
National Drug Code (NDC) number assigned to that device is rescinded, 
and you may no longer provide an NHRIC or NDC number on the label of 
your device or on any device package.
    6. Revise Sec.  801.119 to read as follows:


Sec.  801.119  In vitro diagnostic products.

    A product intended for use in the diagnosis of disease and which is 
an in vitro diagnostic product as defined in Sec.  809.3(a) of this 
chapter shall be deemed to be in compliance with the requirements of 
this part and section 502(f)(1) of the Federal Food, Drug, and Cosmetic 
Act if it meets the requirements of subpart B of this part and the 
requirements of Sec.  809.10 of this chapter.
    7. Amend Sec.  801.128 by redesignating paragraphs (f)(2) through 
(f)(7) as (f)(3) through (f)(8), and by adding new paragraph (f)(2) to 
read as follows:


Sec.  801.128  Exceptions or alternatives to labeling requirements for 
medical devices held by the Strategic National Stockpile.

* * * * *
    (f) * * *
    (2) Subpart B of this part and part 830 in its entirety;
* * * * *

PART 803--MEDICAL DEVICE REPORTING

    8. The authority citation for part 803 continues to read as 
follows:

    Authority: 21 U.S.C. 352, 360, 360i, 360j, 371, 374.

    9. Amend Sec.  803.3 by alphabetically adding the definition for 
``Unique device identifier (UDI)'' to read as follows:


Sec.  803.3  How does FDA define the terms used in this part?

* * * * *
    Unique device identifier (UDI) means an identifier that adequately 
identifies a device through its distribution and use by meeting the 
requirements of Sec.  830.20 of this chapter. A unique device 
identifier is composed of:
    (1) A device identifier--a mandatory, fixed portion of a UDI that 
identifies the specific version or model of a device and the labeler of 
that device; and
    (2) A production identifier--a conditional, variable portion of a 
UDI that identifies one or more of the following when included on the 
label of the device:

[[Page 40772]]

    (i) The lot or batch within which a device was manufactured;
    (ii) The serial number of a specific device;
    (iii) The expiration date of a specific device;
    (iv) The date a specific device was manufactured.
* * * * *
    10. Amend Sec.  803.32 by redesignating paragraphs (c)(6) through 
(c)(10) as paragraphs (c)(7) through (c)(11), and by adding new 
paragraph (c)(6) to read as follows:


Sec.  803.32  If I am a user facility, what information must I submit 
in my individual adverse event reports?

* * * * *
    (c) * * *
    (6) The unique device identifier (UDI) that appears on the device 
label or on the device package;
* * * * *
    11. Amend Sec.  803.33 by redesignating paragraphs (a)(7)(iv) 
through (a)(7)(vi) as paragraphs (a)(7)(v) through (a)(7)(vii), and by 
adding new paragraph (a)(7)(iv) to read as follows:


Sec.  803.33  If I am a user facility, what must I include when I 
submit an annual report?

    (a) * * *
    (7) * * *
    (iv) The unique device identifier (UDI) that appears on the device 
label or on the device package;
* * * * *
    12. Amend Sec.  803.42 by redesignating paragraphs (c)(6) through 
(c)(10) as paragraphs (c)(7) through (c)(11), and by adding new 
paragraph (c)(6) to read as follows:


Sec.  803.42  If I am an importer, what information must I submit in my 
individual adverse event reports?

* * * * *
    (c) * * *
    (6) The unique device identifier (UDI) that appears on the device 
label or on the device package;
* * * * *
    13. Amend Sec.  803.52 by redesignating paragraphs (c)(6) through 
(c)(10) as paragraphs (c)(7) through (c)(11), and by adding new 
paragraph (c)(6) to read as follows:


Sec.  803.52  If I am a manufacturer, what information must I submit in 
my individual adverse event reports?

* * * * *
    (c) * * *
    (6) The unique device identifier (UDI) that appears on the device 
label or on the device package;
* * * * *

PART 806--MEDICAL DEVICES; REPORTS OF CORRECTIONS AND REMOVALS

    14. The authority citation for part 806 continues to read as 
follows:

    Authority: 21 U.S.C. 352, 360, 360i, 360j, 371, 374.

    15. Amend Sec.  806.2 by adding paragraph (m) to read as follows:


Sec.  806.2  Definitions.

* * * * *
    (m) Unique device identifier (UDI) means an identifier that 
adequately identifies a device through its distribution and use by 
meeting the requirements of Sec.  830.20 of this chapter. A unique 
device identifier is composed of:
    (1) A device identifier--a mandatory, fixed portion of a UDI that 
identifies the specific version or model of a device and the labeler of 
that device; and
    (2) A production identifier--a conditional, variable portion of a 
UDI that identifies one or more of the following when included on the 
label of the device:
    (i) The lot or batch within which a device was manufactured;
    (ii) The serial number of a specific device;
    (iii) The expiration date of a specific device;
    (iv) The date a specific device was manufactured.
    16. Amend Sec.  806.10 by revising paragraph (c)(5) to read as 
follows:


Sec.  806.10  Reports of corrections and removals.

* * * * *
    (c) * * *
    (5) The unique device identifier (UDI) that appears on the device 
label or on the device package, or the device identifier, universal 
product code (UPC), model, catalog, or code number of the device and 
the manufacturing lot or serial number of the device or other 
identification number.
* * * * *
    17. Amend Sec.  806.20 by revising paragraph (b)(2) to read as 
follows:


Sec.  806.20  Records of corrections and removals not required to be 
reported.

* * * * *
    (b) * * *
    (2) The unique device identifier (UDI) of the device, or the device 
identifier, universal product code (UPC), model, catalog, or code 
number of the device and the manufacturing lot or serial number of the 
device or other identification number.
* * * * *

PART 810--MEDICAL DEVICE RECALL AUTHORITY

    18. The authority citation for part 810 is revised to read as 
follows:

    Authority: 21 U.S.C. 321, 331, 332, 333, 334, 351, 352, 355, 
360h, 360i, 371, 374, 375.

    19. Amend Sec.  810.2 by adding paragraph (l) to read as follows:


Sec.  810.2  Definitions.

* * * * *
    (l) Unique device identifier (UDI) means an identifier that 
adequately identifies a device through its distribution and use by 
meeting the requirements of Sec.  830.20 of this chapter. A unique 
device identifier is composed of:
    (1) A device identifier--a mandatory, fixed portion of a UDI that 
identifies the specific version or model of a device and the labeler of 
that device; and
    (2) A production identifier--a conditional, variable portion of a 
UDI that identifies one or more of the following when included on the 
label of the device:
    (i) The lot or batch within which a device was manufactured;
    (ii) The serial number of a specific device;
    (iii) The expiration date of a specific device;
    (iv) The date a specific device was manufactured.
    20. Amend Sec.  810.10 by removing the word ``and'' at the end of 
paragraph (b)(2)(iii) and by adding paragraph (b)(2)(v) to read as 
follows:


Sec.  810.10  Cease distribution and notification order.

* * * * *
    (b) * * *
    (2) * * *
    (v) The unique device identifier (UDI) that appears on the device 
label or on the device package; and
* * * * *

PART 814--PREMARKET APPROVAL OF MEDICAL DEVICES

    21. The authority citation for part 814 continues to read as 
follows:

    Authority: 21 U.S.C. 351, 352, 353, 360, 360c-360j, 371, 372, 
373, 374, 375, 379, 379e, 381.

    22. Amend Sec.  814.3 by adding paragraphs (p) and (q) to read as 
follows:


Sec.  814.3  Definitions.

* * * * *
    (p) Unique device identifier (UDI) means an identifier that 
adequately identifies a device through its distribution and use by 
meeting the

[[Page 40773]]

requirements of Sec.  830.20 of this chapter. A unique device 
identifier is composed of:
    (1) A device identifier--a mandatory, fixed portion of a UDI that 
identifies the specific version or model of a device and the labeler of 
that device; and
    (2) A production identifier--a conditional, variable portion of a 
UDI that identifies one or more of the following when included on the 
label of the device:
    (i) The lot or batch within which a device was manufactured;
    (ii) The serial number of a specific device;
    (iii) The expiration date of a specific device;
    (iv) The date a specific device was manufactured.
    (q) Universal product code (UPC) means the product identifier used 
to identify a company and product name of an item sold at retail in the 
United States.
    23. Amend Sec.  814.84 by adding paragraph (b)(4) to read as 
follows:


Sec.  814.84  Reports.

* * * * *
    (b) * * *
    (4) Identify each device identifier currently in use for the 
device, and each device identifier for the device that has been 
discontinued since the previous periodic report. It is not necessary to 
identify any device identifier discontinued prior to [A DATE WILL BE 
ADDED 90 DAYS AFTER DATE OF PUBLICATION OF THE FINAL RULE IN THE 
FEDERAL REGISTER].

PART 820--QUALITY SYSTEM REGULATION

    24. The authority citation for part 820 continues to read as 
follows:

    Authority: 21 U.S.C. 351, 352, 360, 360c, 360d, 360e, 360h, 
360i, 360j, 360l, 371, 374, 381, 383; 42 U.S.C. 216, 262, 263a, 264.

    25. Amend Sec.  820.3 by adding paragraphs (bb) and (cc) to read as 
follows:


Sec.  820.3  Definitions.

* * * * *
    (bb) Unique device identifier (UDI) means an identifier that 
adequately identifies a device through its distribution and use by 
meeting the requirements of Sec.  830.20 of this chapter. A unique 
device identifier is composed of:
    (1) A device identifier--a mandatory, fixed portion of a UDI that 
identifies the specific version or model of a device and the labeler of 
that device; and
    (2) A production identifier--a conditional, variable portion of a 
UDI that identifies one or more of the following when included on the 
label of the device:
    (i) The lot or batch within which a device was manufactured;
    (ii) The serial number of a specific device;
    (iii) The expiration date of a specific device;
    (iv) The date a specific device was manufactured.
    (cc) Universal product code (UPC) means the product identifier used 
to identify a company and product name of an item sold at retail in the 
United States.
    26. Amend Sec.  820.120 by revising the first sentence of paragraph 
(b) to read as follows:


Sec.  820.120  Device labeling.

* * * * *
    (b) Labeling inspection. Labeling shall not be released for storage 
or use until a designated individual(s) has examined the labeling for 
accuracy including, where applicable, the correct unique device 
identifier (UDI) or universal product code (UPC), expiration date, 
control number, storage instructions, handling instructions, and any 
additional processing instructions. * * *
* * * * *
    27. Amend Sec.  820.184 by revising paragraph (f) to read as 
follows:


Sec.  820.184  Device history record.

* * * * *
    (f) Any unique device identifier (UDI) or universal product code 
(UPC), and any other device identification(s) and control number(s) 
used.
    28. Amend Sec.  820.198 by revising paragraph (e)(3) to read as 
follows:


Sec.  820.198  Complaint files.

* * * * *
    (e) * * *
    (3) Any unique device identifier (UDI) or universal product code 
(UPC), and any other device identification(s) and control number(s) 
used;
* * * * *
    29. Amend Sec.  820.200 by revising paragraph (d)(2) to read as 
follows:


Sec.  820.200  Servicing.

* * * * *
    (d) * * *
    (2) Any unique device identifier (UDI) or universal product code 
(UPC), and any other device identification(s) and control number(s) 
used;
* * * * *

PART 821--MEDICAL DEVICE TRACKING REQUIREMENTS

    30. The authority citation for part 821 continues to read as 
follows:

    Authority: 21 U.S.C. 331, 351, 352, 360, 360e, 360h, 360i, 371, 
374.

    31. Amend Sec.  821.3 by adding paragraph (n) to read as follows:


Sec.  821.3  Definitions.

* * * * *
    (n) Unique device identifier (UDI) means an identifier that 
adequately identifies a device through its distribution and use by 
meeting the requirements of Sec.  830.20 of this chapter. A unique 
device identifier is composed of:
    (1) A device identifier--a mandatory, fixed portion of a UDI that 
identifies the specific version or model of a device and the labeler of 
that device; and
    (2) A production identifier--a conditional, variable portion of a 
UDI that identifies one or more of the following when included on the 
label of the device:
    (i) The lot or batch within which a device was manufactured;
    (ii) The serial number of a specific device;
    (iii) The expiration date of a specific device;
    (iv) The date a specific device was manufactured.
    32. Amend Sec.  821.25 by revising paragraphs (a)(2)(i) and 
(a)(3)(i) to read as follows:


Sec.  821.25  Device tracking system and content requirements: 
manufacturer requirements.

    (a) * * *
    (2) * * *
    (i) The unique device identifier (UDI), lot number, batch number, 
model number, or serial number of the device or other identifier 
necessary to provide for effective tracking of the devices;
* * * * *
    (3) * * *
    (i) The unique device identifier (UDI), lot number, batch number, 
model number, or serial number of the device or other identifier 
necessary to provide for effective tracking of the devices;
* * * * *
    33. Amend Sec.  821.30 by revising paragraphs (a)(2), (b)(2), and 
(c)(1)(i) to read as follows:


Sec.  821.30  Tracking obligations of persons other than device 
manufacturers: distributor requirements.

    (a) * * *
    (2) The unique device identifier (UDI), lot number, batch number, 
model number, or serial number of the device or other identifier used 
by the manufacturer to track the device;
* * * * *
    (b) * * *
    (2) The unique device identifier (UDI), lot number, batch number, 
model

[[Page 40774]]

number, or serial number of the device or other identifier used by the 
manufacturer to track the device;
* * * * *
    (c) * * *
    (1) * * *
    (i) The unique device identifier (UDI), lot number, batch number, 
model number, or serial number of the device or other identifier used 
by the manufacturer to track the device;
* * * * *

PART 822--POSTMARKET SURVEILLANCE

    34. The authority citation for part 822 continues to read as 
follows:

    Authority: 21 U.S.C. 331, 352, 360i, 360l, 371, 374.

    35. Amend Sec.  822.3 by adding paragraph (n) to read as follows:


Sec.  822.3  How do you define the terms used in this part?

* * * * *
    (n) Unique device identifier (UDI) means an identifier that 
adequately identifies a device through its distribution and use by 
meeting the requirements of Sec.  830.20 of this chapter. A unique 
device identifier is composed of:
    (1) A device identifier--a mandatory, fixed portion of a UDI that 
identifies the specific version or model of a device and the labeler of 
that device; and
    (2) A production identifier--a conditional, variable portion of a 
UDI that identifies one or more of the following when included on the 
label of the device:
    (i) The lot or batch within which a device was manufactured;
    (ii) The serial number of a specific device;
    (iii) The expiration date of a specific device;
    (iv) The date a specific device was manufactured.
    36. Amend Sec.  822.9 by revising paragraph (a)(4) to read as 
follows:


Sec.  822.9  What must I include in my submission?

* * * * *
    (a) * * *
    (4) Premarket application/submission number and device identifiers 
for your device;
* * * * *
    37. Add part 830 to read as follows:

PART 830--UNIQUE DEVICE IDENTIFICATION

Subpart A--General Provisions
Sec.
830.3 Definitions.
Subpart B--Requirements for a Unique Device Identifier (UDI)
830.10 Incorporation by reference--Technical standards applicable to 
part 830.
830.20 Requirements for a unique device identifier.
830.40 Use and discontinuation of a device identifier.
830.50 Changes that result in a new version or model.
830.60 Relabeling of a device that is required to bear a unique 
device identifier.
Subpart C--FDA Accreditation of an Issuing Agency
830.100 FDA accreditation of an issuing agency.
830.110 Application for accreditation as an issuing agency.
830.120 Responsibilities of an FDA-accredited issuing agency.
830.130 Suspension or revocation of the accreditation of an issuing 
agency.
Subpart D--FDA as an Issuing Agency
830.200 When FDA will act as an issuing agency.
830.210 Eligibility for use of FDA as an issuing agency.
830.220 Termination of FDA service as an issuing agency.
Subpart E--Global Unique Device Identification Database
830.300 Devices subject to device identification data submission 
requirements.
830.310 Information required for unique device identification.
830.320 Submission of unique device identification information.
830.330 Times for submission of unique device identification 
information.
830.340 Voluntary submission of ancillary device identification 
information.
830.350 Records to be maintained by the labeler.

    Authority:  21 U.S.C. 321, 331, 352, 353, 360, 360d, 360i, 360j, 
371.

Subpart A--General Provisions


Sec.  830.3  Definitions.

    Automatic identification and data capture (AIDC) means any 
technology that conveys the unique device identifier (UDI) or the 
device identifier of a device in a form that can be entered into an 
electronic patient record or other computer system via an automated 
process.
    Center Director means the Director of the Center for Devices and 
Radiological Health or the Director of the Center for Biologics 
Evaluation and Research, depending on which Center has been assigned 
lead responsibility for the device.
    Device package means a package that contains a fixed quantity of 
devices.
    Expiration date means the date by which the label of a device 
states the device must or should be used.
    FDA, we, or us means the Food and Drug Administration.
    Federal Food, Drug, and Cosmetic Act means 21 U.S.C. 321 et seq., 
as amended.
    Global Unique Device Identification Database (GUDID) means the 
database that serves as a repository of information to facilitate the 
identification of medical devices through their distribution and use.
    Issuing agency means an organization accredited by FDA to operate a 
system for the issuance of unique device identifiers.
    Label has the meaning set forth in section 201(k) of the Federal 
Food, Drug, and Cosmetic Act.
    Labeler means:
    (1) Any person who causes a label to be applied to a device with 
the intent that the device will be introduced into interstate commerce 
without any subsequent replacement or modification of the label; and
    (2) Any person who causes the label of a device to be modified with 
the intent that the device will be introduced into interstate commerce 
without any subsequent replacement or modification of the label, except 
that the addition of the name of, and contact information for, a person 
who distributes the device, without making any other changes to the 
label, is not a modification for the purposes of determining whether a 
person is a labeler.
    Lot or batch means one finished device (any device or accessory to 
any device that is suitable for use or capable of functioning) or more 
that consist of a single type, model, class, size, composition, or 
software version that are manufactured under essentially the same 
conditions and that are intended to have uniform characteristics and 
quality within specified limits.
    Premarket submission means a premarket approval application; a 
product development protocol; a premarket report; a humanitarian device 
exemption application; a biologics license application; a supplement; a 
premarket notification submission; or a new drug application for a 
transitional device:
    (1) Premarket approval application means an application for 
approval of a device submitted under section 515(c) of the Federal 
Food, Drug, and Cosmetic Act;
    (2) Product development protocol means the application described in 
section 515(f) of the Federal Food, Drug, and Cosmetic Act.

[[Page 40775]]

    (3) Premarket report means a report submitted under section 
515(c)(2) of the Federal Food, Drug, and Cosmetic Act;
    (4) Humanitarian device exemption application means an application 
for approval of a humanitarian use device submitted under section 
520(m) of the Federal Food, Drug, and Cosmetic Act;
    (5) Biologics license application means an application for approval 
of a device submitted under section 351 of the Public Health Service 
Act.
    (6) Premarket notification submission means a report submitted 
under section 510(k) of the Federal Food, Drug, and Cosmetic Act;
    (7) New drug application for a transitional device means a new drug 
application for a medical device that was regulated by FDA as a new 
drug prior to May 28, 1976, the date of enactment of the Medical Device 
Amendments of 1976.
    Shipping container means a package, container, or pallet used 
during the shipment or transportation of devices from one point to 
another, and whose contents may vary from one shipment to another.
    Small business means a medical device manufacturer with 500 or 
fewer employees, or a medical device relabeler or repackager with 100 
or fewer employees.
    Specification means any requirement with which a device must 
conform.
    Unique device identifier (UDI) means an identifier that adequately 
identifies a device through its distribution and use by meeting the 
requirements of Sec.  830.20. A unique device identifier is composed 
of:
    (1) A device identifier--a mandatory, fixed portion of a UDI that 
identifies the specific version or model of a device and the labeler of 
that device; and
    (2) A production identifier--a conditional, variable portion of a 
UDI that identifies one or more of the following when included on the 
label of the device:
    (i) The lot or batch within which a device was manufactured;
    (ii) The serial number of a specific device;
    (iii) The expiration date of a specific device;
    (iv) The date a specific device was manufactured.
    Universal product code (UPC) means the product identifier used to 
identify a company and product name of an item sold at retail in the 
United States.
    Version or model means a device package containing one or more 
devices that have identical specifications, performance, size, and 
composition, within specified limits.

Subpart B--Requirements for a Unique Device Identifier (UDI)


Sec.  830.10  Incorporation by reference--technical standards 
applicable to part 830.

    (a) The following technical standards are incorporated by reference 
with the approval of the Director of the Federal Register in accordance 
with 5 U.S.C. 552(a) and 1 CFR part 51:
    (1) ISO/IEC 646:1991, Information technology--ISO 7-bit coded 
character set for information interchange (third edition, December 15, 
1991).
    (2) ISO/IEC 15459-2:2006(E), Information technology--Unique 
identifiers--Part 2: Registration procedures (second edition, March 1, 
2006);
    (3) ISO/IEC 15459-4:2008, Information technology--Unique 
identifiers--Part 4: Individual items (second edition, July 7, 2008);
    (4) ISO/IEC 15459-6:2007, Information technology--Unique 
identifiers--Part 6: Unique identifier for product groupings (first 
edition, June 15, 2007);
    (b) Copies are available for purchase from: ISO Central 
Secretariat, International Organization for Standardization (ISO), 1, 
ch. de la Voie-Creuse, Case postale 56, CH-1211 Geneva 20, Switzerland, 
telephone (dialing from the United States): 011-41-22-749-0111, 
Internet: www.standardsinfo.net, and are available for inspection at: 
Division of Dockets Management (HFA-305), Food and Drug Administration, 
5630 Fishers Lane, rm. 1061, Rockville, MD 20852, 301-827-6860, and at 
the National Archives and Records Administration (NARA). For 
information on how to review these standards at NARA, call 202-741-
6030, or go to: www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.


Sec.  830.20  Requirements for a unique device identifier.

    A unique device identifier (UDI) must:
    (a) Be issued under a system operated by FDA or an FDA-accredited 
issuing agency;
    (b) Conform to international standards incorporated by reference by 
Sec.  830.10;
    (c) Use only characters and numbers from the invariant character 
set of ISO/IEC 646:1991, Information technology--ISO 7-bit coded 
character set for information interchange.


Sec.  830.40  Use and discontinuation of a device identifier.

    (a) Only one device identifier from any particular system for the 
issuance of unique device identifiers may be used to identify a 
particular version or model of a device. A particular version or model 
may be identified by unique device identifiers (UDIs) from two or more 
systems for the issuance of UDIs.
    (b) A device identifier shall be used to identify only one version 
or model.
    (c) In the event that a version or model of a device is 
discontinued, its device identifier may not be reassigned to another 
device. If a discontinued version or model is re-introduced and no 
changes have been made that would require the use of a new device 
identifier, the device identifier that was previously in use may be 
used to identify the device.
    (d) In the event that an issuing agency relinquishes or does not 
renew its accreditation, you may continue to label a device with a 
previously-issued UDI until such time as Sec.  830.50 requires you to 
discontinue use of the UDI.


Sec.  830.50  Changes that result in a new version or model.

    If you make any of the following changes to a device that is 
required to bear a UDI on its label, the change results in a new 
version or model and you must assign a new device identifier to the new 
version or model:
    (a) You change the specifications, performance, size, or 
composition of the device to an extent greater than the specified 
limits;
    (b) You change the quantity in a device package or add a new device 
package;
    (c) You make a change that could significantly affect the safety or 
effectiveness of the device;
    (d) You change from a nonsterile package to a sterile package, or 
from a sterile package to a nonsterile package; or
    (e) You relabel the device.


Sec.  830.60  Relabeling of a device that is required to bear a unique 
device identifier.

    If you relabel a device that is required to bear a unique device 
identifier (UDI), you must keep a record showing the relationship of 
the prior device identifier to your new device identifier.

Subpart C--FDA Accreditation of an Issuing Agency


Sec.  830.100  FDA accreditation of an issuing agency.

    (a) Eligibility. A private nonprofit organization or a State agency 
may apply for accreditation as an issuing agency.
    (b) Accreditation criteria. FDA may accredit an organization as an 
issuing agency, if the system it will operate:

[[Page 40776]]

    (1) Will employ unique device identifiers (UDIs) that meet the 
requirements of this part to adequately identify a device through its 
distribution and use;
    (2) Conforms to the international standards incorporated by 
reference at Sec.  830.10;
    (3) Will be available to all users according to a single set of 
consistent, fair, and reasonable terms and conditions.


Sec.  830.110  Application for accreditation as an issuing agency.

    (a) Application for initial accreditation. (1) An applicant seeking 
initial FDA accreditation as an issuing agency shall notify FDA of its 
desire to be accredited by sending a notification to: Division of Small 
Manufacturers, Consumer, and International Assistance (DSMICA), Center 
for Devices and Radiological Health, Bldg. 66, rm. 4621, 10903 New 
Hampshire Ave., Silver Spring, MD 20993.
    (2) Following receipt of the notification. FDA will provide the 
applicant with additional information to aid in submission of an 
application for approval as an issuing agency, together with an email 
address for submission of an application.
    (3) The applicant shall furnish to FDA, via email to the email 
address we provide, an application containing the following 
information, materials, and supporting documentation:
    (i) Name, address, and phone number of the applicant and, if the 
applicant is not a State agency, evidence of nonprofit status (for 
example, how it meets Internal Revenue Service requirements for a 
nonprofit organization);
    (ii) Detailed descriptions of any standards or criteria the 
applicant will apply to participating labelers;
    (iii) A detailed description of the guidelines that govern 
assignment of a unique device identifier (UDI) to a device;
    (iv) A detailed description of the review and decision-making 
process the applicant will apply when determining whether a particular 
labeler may use the applicant's UDI system, including:
    (A) Copies of the application forms, guidelines, instructions, and 
other materials the applicant will send to medical device labelers who 
wish to use the applicant's unique device identification system;
    (B) Policies and procedures for notifying a labeler of deficiencies 
in its use of unique device identifiers;
    (C) Procedures for monitoring a labeler's correction of 
deficiencies in its use of unique device identifiers;
    (D) Policies and procedures for suspending or revoking a labeler's 
use of the applicant's UDI system, including any appeals process.
    (v) Description of the applicant's electronic data management 
system with respect to its review and decision processes and the 
applicant's ability to provide electronic data in a format compatible 
with FDA data systems;
    (vi) Fee schedules, if any, together with an explanation of any fee 
waivers or reductions that are available; and
    (vii) Other information required by FDA to clarify the application 
for accreditation.
    (b) Application for renewal of accreditation. An accredited issuing 
agency that intends to continue to serve as an issuing agency beyond 
its current term shall apply to FDA for renewal or notify FDA of its 
plans not to apply for renewal in accordance with the following 
procedures and schedule:
    (1) At least 9 months before the date of expiration of its 
accreditation, an issuing agency shall inform FDA, at the address given 
in paragraph (a)(1) of this section, of its intent to seek renewal.
    (2) FDA will notify the issuing agency of the relevant information, 
materials, and supporting documentation that we will require the 
issuing agency to submit as part of the renewal procedure. We will 
tailor these requirements to reflect our experience with the issuing 
agency during the current and any prior period of accreditation. We 
will limit our request to the types of the information required by 
paragraph (a)(3) of this section, and we will require less information 
if experience shows that we need only a subset of that information.
    (3) At least 6 months before the date of expiration of its 
accreditation, an issuing agency shall furnish to FDA, at the email 
address we provide, a copy of a renewal application containing the 
information, materials, and supporting documentation requested by FDA 
in accordance with paragraph (b)(2) of this section.
    (4) Any issuing agency that does not plan to renew its 
accreditation shall so notify FDA at the address given in paragraph 
(a)(1) of this section at least 9 months before the expiration of the 
issuing agency's term of accreditation and shall include a description 
of its plans for allowing continued use of unique device identifiers 
issued prior to the expiration of the current term of accreditation.
    (c) FDA action on an application for initial or renewal 
accreditation. (1) FDA will conduct a review and evaluation to 
determine whether the applicant meets the requirements of this subpart 
and whether the UDI system proposed by the applicant will meet the 
requirements of this subpart.
    (2) Within 60 days of receipt of an application for accreditation, 
FDA will notify the applicant of any deficiencies in its application 
and will request correction of those deficiencies within 60 days. The 
applicant may request an extension if it needs additional time to 
correct deficiencies in its application. If the deficiencies are not 
resolved to FDA's satisfaction within the specified time period, the 
application for accreditation as an issuing agency may be denied.
    (3) FDA shall notify the applicant whether the application for 
accreditation has been granted or denied. That notification shall list 
any conditions of approval or state the reasons for denial.
    (4) If FDA denies an application, we will advise the applicant of 
the circumstances under which a denied application may be resubmitted.
    (5) If FDA does not reach a final decision on a renewal application 
before the expiration of an issuing agency's current accreditation, the 
approval will be deemed extended until FDA reaches a final decision on 
the application.
    (d) Relinquishment of accreditation. If an issuing agency decides 
to relinquish its accreditation before expiration of the current term 
of accreditation, it shall submit a letter of such intent to FDA, at 
the address provided in paragraph (a)(1) of this section, at least 9 
months before relinquishing its accreditation.
    (e) Notice of termination of accreditation. An issuing agency that 
does not apply for renewal of its accreditation, is denied renewal of 
accreditation by FDA, or relinquishes its accreditation and duties 
before expiration of the current term of accreditation, shall notify 
all labelers that are using the issuing agency's UDI system, in a 
manner and time period approved by FDA, of the date that the issuing 
agency will cease to serve as an FDA-accredited issuing agency.
    (f) Term of accreditation. The initial term of accreditation for an 
issuing agency shall be for a period of 3 years. An issuing agency's 
term of accreditation may be periodically renewed for a period of 7 
years.


Sec.  830.120  Responsibilities of an FDA-accredited issuing agency.

    To maintain its accreditation, an issuing agency must:
    (a) Operate a system for assignment of unique device identifiers 
that meets the requirements of Sec.  830.20 and the standards 
incorporated by reference at Sec.  830.10;

[[Page 40777]]

    (b) Make available information concerning its system for the 
assignment of unique device identifiers;
    (c) Maintain a list of labelers that use its system for the 
assignment of unique device identifiers and provide FDA a copy of such 
list in electronic form by December 31 of each year;
    (d) Upon request, provide FDA with information concerning a labeler 
that is employing the issuing agency's system for assignment of unique 
device identifiers; and
    (e) Remain in compliance with the eligibility and accreditation 
criteria set forth in Sec.  830.100.


Sec.  830.130  Suspension or revocation of the accreditation of an 
issuing agency.

    FDA may suspend or revoke the accreditation of an issuing agency if 
FDA finds, after providing the issuing agency with notice and 
opportunity for an informal hearing in accordance with part 16 of this 
chapter, that the issuing agency or any employee of the issuing Agency:
    (a) Has been guilty of misrepresentation in obtaining 
accreditation;
    (b) Has failed to fulfill the responsibilities outlined in Sec.  
830.120; or
    (c) Has violated or aided and abetted in the violation of any 
regulation issued under section 510(e) or section 519(f) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 360(e) and 21 U.S.C. 360i(f), 
respectively).

Subpart D--FDA as an Issuing Agency


Sec.  830.200  When FDA will act as an issuing agency.

    (a) During any period where there is no accredited issuing agency, 
FDA will act as an issuing agency.
    (b) If FDA determines that a significant number of small businesses 
would be substantially and adversely affected by the fees required by 
all accredited issuing agencies, FDA will act as an issuing agency.
    (c) FDA may, in its discretion, act as an issuing agency if we 
determine it is necessary for us to do so to ensure the continuity or 
the effectiveness of the system for the identification of medical 
devices.
    (d) FDA may, in its discretion, act as an issuing agency if we 
determine it is appropriate for us to do so in order to facilitate or 
implement an alternative granted under Sec.  801.35 of this chapter.


Sec.  830.210  Eligibility for use of FDA as an issuing agency.

    When FDA acts as an issuing agency, any labeler will be permitted 
to use FDA's unique device identification system, regardless of whether 
the labeler is considered a small business.


Sec.  830.220  Termination of FDA service as an issuing agency.

    (a) FDA may end our services as an issuing agency if we determine 
that the conditions that prompted us to act no longer exist and that 
ending our services would not be likely to lead to a return of the 
conditions that prompted us to act.
    (b) If FDA has ended our services as an issuing agency, a labeler 
may continue to use a device identifier assigned under FDA's unique 
device identification system until such time as Sec.  830.50 requires 
the use of a new device identifier.

Subpart E--Global Unique Device Identification Database


Sec.  830.300  Devices subject to device identification data submission 
requirements.

    (a) In general. The labeler of a device must provide the 
information required by this subpart for each version or model required 
to be labeled with a unique device identifier.
    (b) Exception. The labeler is not required to submit information 
concerning any device whose label is not required to bear a unique 
device identifier (UDI) because the device is subject to a labeling 
exception under Sec.  801.30, Sec.  801.35, or Sec.  801.128(f)(2) of 
this chapter, regardless of whether the labeler voluntarily includes a 
UDI on the label of the device.
    (c) Voluntary submission of information. If a labeler voluntarily 
includes a UDI on the label of a device under Sec.  801.40, or, for 
devices sold at retail, the label includes a Universal Product Code 
(UPC), the labeler may also voluntarily submit information concerning 
that device under this part.
    (d) Exclusions. FDA may reject or remove any device identification 
data where:
    (1) The device identifier submitted does not conform to Sec.  
830.20;
    (2) The information concerns a device that is neither manufactured 
in the United States nor in interstate commerce in the United States,
    (3) The information concerns a product that FDA determines is not a 
device or a combination product that includes a device constituent 
part,
    (4) The information concerns a device or a combination product that 
requires, but does not have, FDA premarket approval or clearance;
    (5) A device that FDA has banned under section 516 of the Federal 
Food, Drug, and Cosmetic Act; or
    (6) FDA has suspended the accreditation of the issuing agency that 
operates the system used by the labeler.


Sec.  830.310  Information required for unique device identification.

    The contact for device identification shall provide FDA with the 
following information concerning each version or model of a device 
required to be labeled with a unique device identifier (UDI):
    (a) Concerning the labeler:
    (1) The name of the labeler;
    (2) A telephone number or email address that will allow FDA to 
communicate with the contact for device identification designated under 
Sec.  830.320(a); and
    (3) The name of each issuing agency whose system is used by the 
labeler to assign unique device identifiers used by the labeler.
    (b) Concerning each version or model of a device labeled with a 
UDI:
    (1) The device identifier portion of the unique device identifier 
assigned to the version or model;
    (2) When reporting a substitution of a new device identifier that 
will be used in lieu of a previously-reported identifier, the device 
identifier that was previously assigned to the version or model;
    (3) If Sec.  801.50 of this chapter requires the device to bear a 
UDI as a permanent marking on the device itself, either:
    (i) A statement that the device identifier that appears as a 
permanent marking on the device is identical to that reported under 
paragraph (b)(1) of this section, or
    (ii) The device identifier portion of the unique device identifier 
that appears as a permanent marking on the device;
    (4) The proprietary, trade, or brand name of the device as it 
appears on the label of the device;
    (5) Any version or model number or similar reference that appears 
on the label of the device;
    (6) If the device is labeled as sterile, a statement to that 
effect;
    (7) If the device is labeled as containing natural rubber latex 
that contacts humans, or is labeled as having packaging containing 
natural rubber latex that contacts humans, as described by Sec. Sec.  
801.437(b)(1), 801.437(b)(3), and 801.437(f) of this chapter, a 
statement to that effect;
    (8) If the device is available in more than one size, the size of 
the particular version or model, together with the unit of measure, as 
it appears on the label of the device;
    (9) The type of production identifiers that appear on the label of 
the device;
    (10) The FDA premarket submission number of a cleared or approved 
device,

[[Page 40778]]

or a statement that FDA has by regulation exempted the device from 
premarket notification;
    (11) The FDA listing number assigned to the device;
    (12) The Global Medical Device Nomenclature (GMDN) code for the 
device;
    (13) The total number of individual devices contained in the device 
package.


Sec.  830.320  Submission of unique device identification information.

    (a) Designation of contact for device identification. Each labeler 
must designate an individual to serve as the point of contact with FDA 
on matters relating to the identification of medical devices marketed 
by the labeler. The contact for device information is responsible for 
ensuring FDA is provided with all information required by this part. 
The contact for device information may authorize an issuing agency or 
any other person to provide information to FDA on behalf of the 
labeler.
    (b) Information shall be submitted via electronic means. All 
information required by this subpart shall be submitted electronically 
to FDA's Global Unique Device Identification Database (GUDID) in a 
format that we can process, review, and archive, unless the labeler has 
obtained a waiver from electronic submission of unique device 
identifier (UDI) data.
    (c) Waiver from electronic submission. (1) A labeler may request a 
waiver from electronic submission of UDI data by submitting a letter 
addressed to the appropriate Center Director explaining why electronic 
submission is not technologically feasible; send the letter to: 
Division of Small Manufacturers, Consumer, and International Assistance 
(DSMICA), Center for Devices and Radiological Health, White Oak Bldg. 
66, rm. 4621, 10903 New Hampshire Ave., Silver Spring, MD 20993.
    (2) If the establishment where the labeler is located has obtained 
a waiver from electronic submission of registration and listing 
information under section 510(p) of the Federal Food, Drug, and 
Cosmetic Act, the labeler is deemed to have a waiver from electronic 
submission of UDI data.
    (3) A labeler that has a waiver from electronic submission of UDI 
data must send a letter containing all of the information required by 
Sec.  830.310, as well as any ancillary information permitted to be 
submitted under Sec.  830.340 that the labeler wishes to submit, within 
the time permitted by Sec.  830.330, addressed to: Division of Small 
Manufacturers, Consumer, and International Assistance (DSMICA), Center 
for Devices and Radiological Health, White Oak Bldg. 66, rm. 4621, 
10903 New Hampshire Ave., Silver Spring, MD 20993.


Sec.  830.330  Times for submission of unique device identification 
information.

    (a) The labeler shall submit to FDA the information required by 
Sec.  830.310 no later than the date the label of the device must bear 
a unique device identifier under Sec.  801.20 of this chapter.
    (b) The labeler of a device shall submit to FDA an update to the 
information required by Sec.  830.310 whenever the information changes. 
The updated information must be submitted no later than the date a 
device is first labeled with the changed information. If the 
information does not appear on the label of a device, the updated 
information must be submitted within 10 business days of the change.


Sec.  830.340  Voluntary submission of ancillary device identification 
information.

    (a) You may not submit any information to the Global Unique Device 
Identification Database (GUDID) other than that specified by Sec.  
830.310, except where FDA acts to permit the submission of specified 
additional types of information, termed ancillary information.
    (b) FDA will provide information through the FDA Web site at http://www.fda.gov/udi concerning the types of ancillary information that may 
be submitted to the GUDID.
    (c) FDA may periodically change the types of ancillary information 
that may be submitted to the GUDID. We will seek comment on any 
proposed change in accordance with the Paperwork Reduction Act and on 
the FDA Web site at http://www.fda.gov/udi at least 60 days before 
making the change.


Sec.  830.350  Records to be maintained by the labeler.

    (a) Each labeler shall retain, and submit to FDA upon specific 
request, records showing all unique device identifiers (UDIs) used to 
identify devices that must be labeled with a UDI, and the particular 
version or model associated with each device identifier. These records 
must be retained for 3 years from the date the labeler ceases to market 
the version or model.
    (b) Compliance with this section does not relieve the labeler of 
the need to comply with recordkeeping requirements of any other FDA 
regulation.

    Dated: July 2, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-16621 Filed 7-3-12; 4:15 pm]
BILLING CODE 4160-01-P