[Federal Register Volume 70, Number 38 (Monday, February 28, 2005)]
[Proposed Rules]
[Pages 9558-9570]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-3833]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 803

[Docket No. 2004N-0527]


Medical Devices; Medical Device Reporting; Companion to Direct 
Final Rule

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule.

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SUMMARY: The Food and Drug Administration (FDA or we) is proposing to 
amend its regulation governing reporting of deaths, serious injuries, 
and certain malfunctions related to medical devices. We are revising 
the regulation into plain language to make the regulation easier to 
understand, and we are making technical corrections. Elsewhere in this 
issue of the Federal Register, we are publishing a direct final rule 
that is identical to this proposed rule. This proposed rule will 
provide a procedural framework to finalize the rule in the event we 
receive any significant adverse comment and withdraw the direct final 
rule.

DATES:  Submit written or electronic comments by May 16, 2005.

[[Page 9559]]


ADDRESSES: You may submit comments, identified by Docket No. 2004N-
0527, by any of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments.
     Agency Web site: http://www.fda.gov/dockets/ecomments. 
Follow the instructions for submitting comments on the agency Web site.
     E-mail: [email protected]. Include Docket No. 2004N-
0527 in the subject line of your e-mail message.
     FAX: 301-827-6870.
     Mail/Hand delivery/Courier [For paper, disk, or CD-ROM 
submissions]: Division of Dockets Management, 5630 Fishers Lane, rm. 
1061, Rockville, MD 20852.
    Instructions: All submissions received must include the agency name 
and Docket No. or Regulatory Information Number (RIN) for this 
rulemaking. All comments received will be posted without change to 
http://www.fda.gov/ohrms/dockets/default.htm, including any personal 
information provided. For detailed instructions on submitting comments 
and additional information on the rulemaking process, 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.fda.gov/ohrms/dockets/default.htm 
and/or the Division of Dockets Management, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Howard Press, Center for Devices and 
Radiological Health (HFZ-531), Food and Drug Administration, 1350 
Piccard Dr., Rockville, MD 20850, 301-827-2983.

SUPPLEMENTARY INFORMATION: This proposed rule is a companion to the 
direct final rule regarding adverse event reporting requirements for 
medical devices that is published in the final rules section of this 
issue of the Federal Register. The direct final rule and this companion 
proposed rule are identical. We are publishing the direct final rule 
because we believe the rule contains noncontroversial changes, and we 
anticipate that it will receive no significant adverse comment. A 
detailed discussion of the rule is set forth in the preamble of the 
direct final rule. If no significant adverse comment is received in 
response to the direct final rule, no further action will be taken 
related to this proposed rule. Instead, we will publish a confirmation 
document within 30 days after the comment period ends confirming that 
the direct final rule will go into effect on July 13, 2005. You can 
find additional information about FDA's direct final rulemaking 
procedures in a guidance published in the Federal Register of November 
21, 1997 (62 FR 62466).
    If we receive any significant adverse comment regarding the direct 
final rule, we will withdraw the direct final rule within 30 days after 
the comment period ends and proceed to respond to all of the comments 
under this companion proposed rule using usual notice-and-comment 
rulemaking procedures. The comment period for this companion proposed 
rule runs concurrently with the direct final rule's comment period. Any 
comments received under this companion proposed rule will also be 
considered as comments regarding the direct final rule.
    A significant adverse comment is defined as a comment that explains 
why the rule would be inappropriate, including challenges to the rule's 
underlying premise or approach, or would be ineffective or unacceptable 
without a change. In determining whether a significant adverse comment 
is sufficient to terminate a direct final rulemaking, we will consider 
whether the comment raises an issue serious enough to warrant a 
substantive response in a notice-and-comment process. Comments that are 
frivolous, insubstantial, or outside the scope of the rule will not be 
considered adverse under this procedure. For example, a comment 
recommending an additional change to the rule will not be considered a 
significant adverse comment, unless the comment states why the rule 
would be ineffective without the additional change. In addition, if a 
significant adverse comment applies to part of a rule and that part can 
be severed from the remainder of the rule, we may adopt as final those 
parts of the rule that are not the subject of a significant adverse 
comment.

I. What Is the Background of This Rule?

    FDA's regulations governing device adverse event reporting, 
codified at part 803 (21 CFR part 803), implement section 519 of the 
Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360i). That 
statutory provision has undergone several changes since its enactment 
as part of the Medical Device Amendments of 1976 (the 1976 amendments) 
(Public Law 94-295). As a result, FDA's regulations at part 803 have 
also undergone multiple revisions.
    In the Federal Register of September 14, 1984 (49 FR 36326), FDA 
first issued final medical device reporting (MDR) regulations (part 
803) for manufacturers and importers under the section 519 of the act, 
requiring reports of deaths, serious injuries, and certain malfunctions 
involving devices.
    To address shortcomings in the 1976 amendments, and to better 
protect the public health by ensuring reporting of device-related 
adverse events, Congress enacted the Safe Medical Devices Act of 1990 
(Public Law 101-629), which amended the statute to add requirements for 
medical device user facilities and distributors to report certain 
device-related adverse events. Reporting regulations for user 
facilities and for distributors became effective by operation of law on 
May 28, 1992, following the November 26, 1991 (56 FR 60024), 
publication of those requirements in a tentative final rule. This 
regulation required user facilities to report deaths to FDA and to 
manufacturers, and to report serious illnesses and injuries to 
manufacturers, or to FDA if the manufacturer was unknown. Distributors 
were required to report deaths and serious illnesses or injuries to FDA 
and to manufacturers, and to report certain malfunctions to 
manufacturers. Existing reporting requirements for manufacturer and 
importers under the 1984 regulation remained in effect.
    In the Federal Register of September 1, 1993 (58 FR 46514), we 
published a notice confirming that the distributor reporting regulation 
had become final and was codified in part 804 (21 CFR part 804). On 
June 16, 1992, the President signed into law the Medical Device 
Amendments of 1992 (the 1992 amendments) (Public Law 102-112) further 
amending certain provisions of section 519 of the act relating to 
reporting of adverse device events. Among other things, the 1992 
amendments amended section 519 of the act to modify the requirements 
for manufacturer and importer reporting. Consequently, under the 
regulation issued September 1, 1993, importers were required to report 
as manufacturers if they were engaged in manufacturing activities or to 
report as distributors if they were engaged solely in distribution 
activities.
    On November 21, 1997, the President signed the Food and Drug 
Administration Modernization Act (FDAMA) (Public Law 105-115) into law. 
FDAMA made several changes regarding the reporting of adverse 
experiences related to devices. In the Federal Register of May 12, 
1998, FDA published a direct final rule (63 FR 26069) and a companion 
proposed rule (63 FR 26129) to implement new amendments to the MDR 
provisions. We

[[Page 9560]]

received significant adverse comments on the 1998 direct final rule and 
the 1998 companion proposed rule; therefore, we withdrew the 1998 
direct final rule and issued a revised final rule on January 26, 2000 
(65 FR 4112). Under the act as amended by FDAMA, distributors are no 
longer required to report adverse events but are required to keep 
records. Importers are still required to report adverse events related 
to medical devices. Because of FDAMA's changes, we revised part 803 and 
rescinded part 804.
    In summary, the present version of part 803, as it is codified in 
the Code of Federal Regulations, imposes the following general 
reporting and recordkeeping requirements:
    Device user facilities must report deaths and serious injuries that 
a device has or may have caused or contributed to, establish and 
maintain adverse event files, and submit annual reports. Manufacturers 
and importers must report deaths and serious injuries that a device has 
or may have caused or contributed to, must report certain device 
malfunctions, and must establish and maintain adverse event files. 
Manufacturers also must submit specified followup and baseline reports. 
Distributors must maintain records of incidents but are not required to 
report these incidents.

II. What Does This Proposed Rule Do?

    This proposed rule does not change the substantive regulatory 
requirements described previously in this document. FDA is revising 
part 803 solely to ensure that despite the many revisions that have 
been made, part 803 is clear and easy to understand. To achieve this 
goal, we have rewritten part 803 into plain language, in accordance 
with the Presidential Memorandum on Plain Language, issued on June 1, 
1998. That memorandum directed the agency to ensure that all of its 
documents are clear and easy to read. Part of achieving that goal 
involves having readers of a regulation feel that it is speaking 
directly to them. Therefore, we have attempted to incorporate plain 
language in this rule as much as possible. We have tried to make each 
section of the proposed rule easy to understand by using clear and 
simple language rather than jargon, by keeping sentences short, and by 
using active voice rather than passive voice whenever possible. We have 
also made changes to improve the consistency of the format and language 
used throughout parallel regulations governing user facilities, 
importers, and manufacturers that were added or amended at different 
times. We would like your comments on the following topics: (1) How 
effectively we have used plain language, (2) the organization and 
format of the proposed rule, and (3) whether these changes have made 
the document clear and easy to read. In addition, in this proposed 
rule, as in the direct final rule, we have made technical corrections 
to several provisions.
    A detailed description of specific changes in the rule is contained 
in the preamble to the direct final rule, published elsewhere in this 
issue of the Federal Register.
    We note that Sec. Sec.  803.55(b)(9) and (b)(10) and 803.58 were 
stayed indefinitely, under notices published in the Federal Registers 
of July 31, 1996 (61 FR 39868 at 39869) and July 23, 1996 (61 FR 38346 
at 38347). This proposed rule does not propose any changes to those 
provisions, which remain stayed indefinitely, but for the sake of 
completeness, we include as follows, the current text of those 
provisions.

III. What Is the Legal Authority for This Proposed Rule?

    This proposed rule, like the existing medical device adverse event 
reporting regulations to which it makes nonsubstantive changes, is 
authorized by sections 502, 510, 519, 520, 701, and 704 of the act (21 
U.S.C. 352, 360, 360i, 360j, 371, and 374).

IV. What Is the Environmental Impact of This Proposed Rule?

    We have determined under 21 CFR 25.30(h) and (i) that this action 
does not have a significant effect on the human environment. Therefore, 
neither an environmental assessment nor an environmental impact 
statement is required.

V. What Is the Economic Impact of This Proposed Rule?

    We have examined the impacts of this proposed rule under Executive 
Order 12866, the Regulatory Flexibility Act (5 U.S.C. 601-612), and the 
Unfunded Mandates Reform Act of 1995 (Public Law 104-4). Executive 
Order 12866 directs 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). We believe that this 
proposed rule is not a significant regulatory action under the 
Executive order.
    The Regulatory Flexibility Act requires agencies to analyze 
regulatory options that would minimize any significant impact of a rule 
on small entities. Because this proposed rule will not change any 
existing requirements or impose any new requirements, we certify that 
this proposed rule, if finalized, will not have a significant economic 
impact on a substantial number of small entities.
    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 $115 million, using the most current (2003) Implicit 
Price Deflator for the Gross Domestic Product. FDA does not expect this 
proposed rule to result in any 1-year expenditure that would meet or 
exceed this amount.

VI. How Does the Paperwork Reduction Act of 1995 Apply to This Proposed 
Rule?

    This rule contains information collection provisions that are 
subject to review by the Office of Management and Budget (OMB) under 
the Paperwork Reduction Act of 1995 (the PRA) (44 U.S.C. 3501-3520). 
The collections of information addressed in the rule have been approved 
by OMB in accordance with the PRA under the regulations governing 
medical device reporting (part 803, OMB control number 0910-0437).

VII. What Are the Federalism Impacts of This Proposed Rule?

    We have analyzed this proposed rule in accordance with the 
principles set forth in Executive Order 13132. We have determined that 
the rule does not contain policies that 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, we have concluded that 
the 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.

VIII. How Do You Submit Comments on This Proposed Rule?

    Interested persons may submit to the Division of Dockets Management 
(see

[[Page 9561]]

ADDRESSES) written or electronic comments regarding this proposed rule. 
Submit a single copy of electronic comments or two paper copies of any 
mailed comments, except that individuals may submit one paper copy. 
Comments are to be identified 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.

List of Subjects in 21 CFR Part 803

    Imports, Medical devices, Reporting and recordkeeping requirements.
    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, it is 
proposed that 21 CFR part 803 be amended as follows:
    1. Part 803 is revised to read as follows:

PART 803--MEDICAL DEVICE REPORTING

Subpart A--General Provisions
Sec.
803.1 What does this part cover?
803.3 How does FDA define the terms used in this part?
803.9 What information from the reports do we disclose to the 
public?
803.10 Generally, what are the reporting requirements that apply to 
me?
803.11 What form should I use to submit reports of individual 
adverse events and where do I obtain these forms?
803.12 Where and how do I submit reports and additional information?
803.13 Do I need to submit reports in English?
803.14 How do I submit a report electronically?
803.15 How will I know if you require more information about my 
medical device report?
803.16 When I submit a report, does the information in my report 
constitute an admission that the device caused or contributed to the 
reportable event?
803.17 What are the requirements for developing, maintaining, and 
implementing written MDR procedures that apply to me?
803.18 What are the requirements for establishing and maintaining 
MDR files or records that apply to me?
803.19 Are there exemptions, variances, or alternative forms of 
adverse event reporting requirements?
Subpart B--Generally Applicable Requirements for Individual Adverse 
Event Reports
803.20 How do I complete and submit an individual adverse event 
report?
803.21 Where can I find the reporting codes for adverse events that 
I use with medical device reports?
803.22 What are the circumstances in which I am not required to file 
a report?
Subpart C--User Facility Reporting Requirements
803.30 If I am a user facility, what reporting requirements apply to 
me?
803.32 If I am a user facility, what information must I submit in my 
individual adverse event reports?
803.33 If I am a user facility, what must I include when I submit an 
annual report?
Subpart D--Importer Reporting Requirements
803.40 If I am an importer, what kinds of individual adverse event 
reports must I submit, when must I submit them, and to whom must I 
submit them?
803.42 If I am an importer, what information must I submit in my 
individual adverse event reports?
Subpart E--Manufacturer Reporting Requirements
803.50 If I am a manufacturer, what reporting requirements apply to 
me?
803.52 If I am a manufacturer, what information must I submit in my 
individual adverse event reports?
803.53 If I am a manufacturer, in which circumstances must I submit 
a 5-day report?
803.55 I am a manufacturer, in what circumstances must I submit a 
baseline report, and what are the requirements for such a report?
803.56 If I am a manufacturer, in what circumstances must I submit a 
supplemental or followup report and what are the requirements for 
such reports?
803.58 Foreign manufacturers.

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

Subpart A--General Provisions


Sec.  803.1   What does this part cover?

    (a) This part establishes the requirements for medical device 
reporting for device user facilities, manufacturers, importers, and 
distributors. If you are a device user facility, you must report deaths 
and serious injuries that a device has or may have caused or 
contributed to, establish and maintain adverse event files, and submit 
summary annual reports. If you are a manufacturer or importer, you must 
report deaths and serious injuries that your device has or may have 
caused or contributed to, you must report certain device malfunctions, 
and you must establish and maintain adverse event files. If you are a 
manufacturer, you must also submit specified followup and baseline 
reports. These reports help us to protect the public health by helping 
to ensure that devices are not adulterated or misbranded and are safe 
and effective for their intended use. If you are a medical device 
distributor, you must maintain records (files) of incidents, but you 
are not required to report these incidents.
    (b) This part supplements and does not supersede other provisions 
of this chapter, including the provisions of part 820 of this chapter.
    (c) References in this part to regulatory sections of the Code of 
Federal Regulations are to chapter I of title 21, unless otherwise 
noted.


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

    Some of the terms we use in this part are specific to medical 
device reporting and reflect the language used in the statute (law). 
Other terms are more general and reflect our interpretation of the law. 
This section defines the following terms as used in this part:
    Act means the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. 301 
et seq., as amended.
    Ambulatory surgical facility (ASF) means a distinct entity that 
operates for the primary purpose of furnishing same day outpatient 
surgical services to patients. An ASF may be either an independent 
entity (i.e., not a part of a provider of services or any other 
facility) or operated by another medical entity (e.g., under the common 
ownership, licensure, or control of an entity). An ASF is subject to 
this regulation regardless of whether it is licensed by a Federal, 
State, municipal, or local government or regardless of whether it is 
accredited by a recognized accreditation organization. If an adverse 
event meets the criteria for reporting, the ASF must report that event 
regardless of the nature or location of the medical service provided by 
the ASF.
    Become aware means that an employee of the entity required to 
report has acquired information that reasonably suggests a reportable 
adverse event has occurred.
    (1) If you are a device user facility, you are considered to have 
``become aware'' when medical personnel, as defined in this section, 
who are employed by or otherwise formally affiliated with your 
facility, obtain information about a reportable event.
    (2) If you are a manufacturer, you are considered to have become 
aware of an event when any of your employees becomes aware of a 
reportable event that is required to be reported within 30 calendar 
days or that is required to be reported within 5 work days because we 
had requested reports in accordance with Sec.  803.53(b). You are also 
considered to have become aware of an event when any of your employees 
with management or supervisory responsibilities over persons with 
regulatory, scientific, or technical responsibilities, or whose duties 
relate

[[Page 9562]]

to the collection and reporting of adverse events, becomes aware, from 
any information, including any trend analysis, that a reportable MDR 
event or events necessitates remedial action to prevent an unreasonable 
risk of substantial harm to the public health.
    (3) If you are an importer, you are considered to have become aware 
of an event when any of your employees becomes aware of a reportable 
event that is required to be reported by you within 30 calendar days.
    Caused or contributed means that a death or serious injury was or 
may have been attributed to a medical device, or that a medical device 
was or may have been a factor in a death or serious injury, including 
events occurring as a result of:
    (1) Failure;
    (2) Malfunction;
    (3) Improper or inadequate design;
    (4) Manufacture;
    (5) Labeling; or
    (6) User error.
    Device family. (1) Device family means a group of one or more 
devices manufactured by or for the same manufacturer and having the 
same:
    (i) Basic design and performance characteristics related to device 
safety and effectiveness,
    (ii) Intended use and function, and
    (iii) Device classification and product code.
    (2) You may consider devices that differ only in minor ways not 
related to safety or effectiveness to be in the same device family. 
When grouping products in device families, you may consider factors 
such as brand name and common name of the device and whether the 
devices were introduced into commercial distribution under the same 
510(k) or premarket approval application (PMA).
    Device user facility means a hospital, ambulatory surgical 
facility, nursing home, outpatient diagnostic facility, or outpatient 
treatment facility as defined in this section, which is not a 
physician's office, as defined in this section. School nurse offices 
and employee health units are not device user facilities.
    Distributor means any person (other than the manufacturer or 
importer) who furthers the marketing of a device from the original 
place of manufacture to the person who makes final delivery or sale to 
the ultimate user, but who does not repackage or otherwise change the 
container, wrapper, or labeling of the device or device package. If you 
repackage or otherwise change the container, wrapper, or labeling, you 
are considered a manufacturer as defined in this section.
    Expected life of a device means the time that a device is expected 
to remain functional after it is placed into use. Certain implanted 
devices have specified ``end of life'' (EOL) dates. Other devices are 
not labeled as to their respective EOL, but are expected to remain 
operational through activities such as maintenance, repairs, or 
upgrades, for an estimated period of time.
    FDA, we, or us means the Food and Drug Administration.
    Five-day report means a medical device report that must be 
submitted by a manufacturer to us under Sec.  803.53, on FDA Form 3500A 
or an electronic equivalent approved under Sec.  803.14, within 5 work 
days.
    Hospital means a distinct entity that operates for the primary 
purpose of providing diagnostic, therapeutic (such as medical, 
occupational, speech, physical), surgical, and other patient services 
for specific and general medical conditions. Hospitals include general, 
chronic disease, rehabilitative, psychiatric, and other special-purpose 
facilities. A hospital may be either independent (e.g., not a part of a 
provider of services or any other facility) or may be operated by 
another medical entity (e.g., under the common ownership, licensure, or 
control of another entity). A hospital is covered by this regulation 
regardless of whether it is licensed by a Federal, State, municipal or 
local government or whether it is accredited by a recognized 
accreditation organization. If an adverse event meets the criteria for 
reporting, the hospital must report that event regardless of the nature 
or location of the medical service provided by the hospital.
    Importer means any person who imports a device into the United 
States and who furthers the marketing of a device from the original 
place of manufacture to the person who makes final delivery or sale to 
the ultimate user, but who does not repackage or otherwise change the 
container, wrapper, or labeling of the device or device package. If you 
repackage or otherwise change the container, wrapper, or labeling, you 
are considered a manufacturer as defined in this section.
    Malfunction means the failure of a device to meet its performance 
specifications or otherwise perform as intended. Performance 
specifications include all claims made in the labeling for the device. 
The intended performance of a device refers to the intended use for 
which the device is labeled or marketed, as defined in Sec.  801.4 of 
this chapter.
    Manufacturer means any person who manufactures, prepares, 
propagates, compounds, assembles, or processes a device by chemical, 
physical, biological, or other procedure. The term includes any person 
who either:
    (1) Repackages or otherwise changes the container, wrapper, or 
labeling of a device in furtherance of the distribution of the device 
from the original place of manufacture;
    (2) Initiates specifications for devices that are manufactured by a 
second party for subsequent distribution by the person initiating the 
specifications;
    (3) Manufactures components or accessories that are devices that 
are ready to be used and are intended to be commercially distributed 
and intended to be used as is, or are processed by a licensed 
practitioner or other qualified person to meet the needs of a 
particular patient; or
    (4) Is the U.S. agent of a foreign manufacturer.
    Manufacturer or importer report number. Manufacturer or importer 
report number means the number that uniquely identifies each individual 
adverse event report submitted by a manufacturer or importer. This 
number consists of the following three parts:
    (1) The FDA registration number for the manufacturing site of the 
reported device, or the registration number for the importer. If the 
manufacturing site or the importer does not have an establishment 
registration number, we will assign a temporary MDR reporting number 
until the site is registered in accordance with part 807 of this 
chapter. We will inform the manufacturer or importer of the temporary 
MDR reporting number;
    (2) The four-digit calendar year in which the report is submitted; 
and
    (3) The five-digit sequence number of the reports submitted during 
the year, starting with 00001. (For example, the complete number will 
appear as follows: 1234567-1995-00001.)
    MDR means medical device report.
    MDR reportable event (or reportable event) means:
    (1) An event that user facilities become aware of that reasonably 
suggests that a device has or may have caused or contributed to a death 
or serious injury, or
    (2) An event that manufacturers or importers become aware of that 
reasonably suggests that one of their marketed devices:
    (i) May have caused or contributed to a death or serious injury, or
    (ii) Has malfunctioned and that the device or a similar device 
marketed by the manufacturer or importer would be likely to cause or 
contribute to a death

[[Page 9563]]

or serious injury if the malfunction were to recur.
    Medical personnel means an individual who:
    (1) Is licensed, registered, or certified by a State, territory, or 
other governing body, to administer health care;
    (2) Has received a diploma or a degree in a professional or 
scientific discipline;
    (3) Is an employee responsible for receiving medical complaints or 
adverse event reports; or
    (4) Is a supervisor of these persons.
    Nursing home means:
    (1) An independent entity (i.e., not a part of a provider of 
services or any other facility) or one operated by another medical 
entity (e.g., under the common ownership, licensure, or control of an 
entity) that operates for the primary purpose of providing:
    (i) Skilled nursing care and related services for persons who 
require medical or nursing care;
    (ii) Hospice care to the terminally ill; or
    (iii) Services for the rehabilitation of the injured, disabled, or 
sick.
    (2) A nursing home is subject to this regulation regardless of 
whether it is licensed by a Federal, State, municipal, or local 
government or whether it is accredited by a recognized accreditation 
organization. If an adverse event meets the criteria for reporting, the 
nursing home must report that event regardless of the nature or 
location of the medical service provided by the nursing home.
    Outpatient diagnostic facility. (1) Outpatient diagnostic facility 
means a distinct entity that:
    (i) Operates for the primary purpose of conducting medical 
diagnostic tests on patients,
    (ii) Does not assume ongoing responsibility for patient care, and
    (iii) Provides its services for use by other medical personnel.
    (2) Outpatient diagnostic facilities include outpatient facilities 
providing radiography, mammography, ultrasonography, 
electrocardiography, magnetic resonance imaging, computerized axial 
tomography, and in vitro testing. An outpatient diagnostic facility may 
be either independent (i.e., not a part of a provider of services or 
any other facility) or operated by another medical entity (e.g., under 
the common ownership, licensure, or control of an entity). An 
outpatient diagnostic facility is covered by this regulation regardless 
of whether it is licensed by a Federal, State, municipal, or local 
government or whether it is accredited by a recognized accreditation 
organization. If an adverse event meets the criteria for reporting, the 
outpatient diagnostic facility must report that event regardless of the 
nature or location of the medical service provided by the outpatient 
diagnostic facility.
    Outpatient treatment facility means a distinct entity that operates 
for the primary purpose of providing nonsurgical therapeutic (medical, 
occupational, or physical) care on an outpatient basis or in a home 
health care setting. Outpatient treatment facilities include ambulance 
providers, rescue services, and home health care groups. Examples of 
services provided by outpatient treatment facilities include the 
following: Cardiac defibrillation, chemotherapy, radiotherapy, pain 
control, dialysis, speech or physical therapy, and treatment for 
substance abuse. An outpatient treatment facility may be either 
independent (i.e., not a part of a provider of services or any other 
facility) or operated by another medical entity (e.g., under the common 
ownership, licensure, or control of an entity). An outpatient treatment 
facility is covered by this regulation regardless of whether it is 
licensed by a Federal, State, municipal, or local government or whether 
it is accredited by a recognized accreditation organization. If an 
adverse event meets the criteria for reporting, the outpatient 
treatment facility must report that event regardless of the nature or 
location of the medical service provided by the outpatient treatment 
facility.
    Patient of the facility means any individual who is being diagnosed 
or treated and/or receiving medical care at or under the control or 
authority of the facility. This includes employees of the facility or 
individuals affiliated with the facility who, in the course of their 
duties, suffer a device-related death or serious injury that has or may 
have been caused or contributed to by a device used at the facility.
    Physician's office means a facility that operates as the office of 
a physician or other health care professional for the primary purpose 
of examination, evaluation, and treatment or referral of patients. 
Examples of physician offices include dentist offices, chiropractor 
offices, optometrist offices, nurse practitioner offices, school nurse 
offices, school clinics, employee health clinics, or freestanding care 
units. A physician's office may be independent, a group practice, or 
part of a Health Maintenance Organization.
    Remedial action means any action other than routine maintenance or 
servicing of a device where such action is necessary to prevent 
recurrence of a reportable event.
    Serious injury means an injury or illness that:
    (1) Is life-threatening,
    (2) Results in permanent impairment of a body function or permanent 
damage to a body structure, or
    (3) Necessitates medical or surgical intervention to preclude 
permanent impairment of a body function or permanent damage to a body 
structure.
    Permanent means irreversible impairment or damage to a body 
structure or function, excluding trivial impairment or damage.
    Shelf life means the maximum time a device will remain functional 
from the date of manufacture until it is used in patient care. Some 
devices have an expiration date on their labeling indicating the 
maximum time they can be stored before losing their ability to perform 
their intended function.
    User facility report number means the number that uniquely 
identifies each report submitted by a user facility to manufacturers 
and to us. This number consists of the following three parts:
    (1) The user facility's 10-digit Centers for Medicare and Medicaid 
Services (CMS) number (if the CMS number has fewer than 10 digits, fill 
the remaining spaces with zeros);
    (2) The four-digit calendar year in which the report is submitted; 
and
    (3) The four-digit sequence number of the reports submitted for the 
year, starting with 0001. (For example, a complete user facility report 
number will appear as follows: 1234560000-2004-0001. If a user facility 
has more than one CMS number, it must select one that will be used for 
all of its MDR reports. If a user facility has no CMS number, it should 
use all zeros in the appropriate space in its initial report (e.g., 
0000000000-2004-0001). We will assign a number for future use and send 
that number to the user facility. This number is used in our record of 
the initial report, in subsequent reports, and in any correspondence 
with the user facility. If a facility has multiple sites, the primary 
site may submit reports for all sites and use one reporting number for 
all sites if the primary site provides the name, address, and CMS 
number for each respective site.)
    Work day means Monday through Friday, except Federal holidays.


Sec.  803.9   What information from the reports do we disclose to the 
public?

    (a) We may disclose to the public any report, including any FDA 
record of a telephone report, submitted under this part. Our 
disclosures are governed by part 20 of this chapter.
    (b) Before we disclose a report to the public, we will delete the 
following:
    (1) Any information that constitutes trade secret or confidential 
commercial

[[Page 9564]]

or financial information under Sec.  20.61 of this chapter;
    (2) Any personal, medical, and similar information, including the 
serial number of implanted devices, which would constitute an invasion 
of personal privacy under Sec.  20.63 of this chapter. However, if a 
patient requests a report, we will disclose to that patient all the 
information in the report concerning that patient, as provided in Sec.  
20.61 of this chapter; and
    (3) Any names and other identifying information of a third party 
that voluntarily submitted an adverse event report.
    (c) We may not disclose the identity of a device user facility that 
makes a report under this part except in connection with:
    (1) An action brought to enforce section 301(q) of the act, 
including the failure or refusal to furnish material or information 
required by section 519 of the act;
    (2) A communication to a manufacturer of a device that is the 
subject of a report required to be submitted by a user facility under 
Sec.  803.30; or
    (3) A disclosure to employees of the Department of Health and Human 
Services, to the Department of Justice, or to the duly authorized 
committees and subcommittees of the Congress.


Sec.  803.10  Generally, what are the reporting requirements that apply 
to me?

    (a) If you are a device user facility, you must submit reports 
(described in subpart C of this part), as follows:
    (1) Submit reports of individual adverse events no later than 10 
work days after the day that you become aware of a reportable event:
    (i) Submit reports of device-related deaths to us and to the 
manufacturer, if known; or
    (ii) Submit reports of device-related serious injuries to the 
manufacturers or, if the manufacturer is unknown, submit reports to us.
    (2) Submit annual reports (described in Sec.  803.33) to us.
    (b) If you are an importer, you must submit reports (described in 
subpart D of this part), as follows:
    (1) Submit reports of individual adverse events no later than 30 
calendar days after the day that you become aware of a reportable 
event:
    (i) Submit reports of device-related deaths or serious injuries to 
us and to the manufacturer; or
    (ii) Submit reports of device-related malfunctions to the 
manufacturer.
    (2) [Reserved]
    (c) If you are a manufacturer, you must submit reports (described 
in subpart E of this part) to us, as follows:
    (1) Submit reports of individual adverse events no later than 30 
calendar days after the day that you become aware of a reportable 
death, serious injury, or malfunction.
    (2) Submit reports of individual adverse events no later than 5 
work days after the day that you become aware of:
    (i) A reportable event that requires remedial action to prevent an 
unreasonable risk of substantial harm to the public health, or
    (ii) A reportable event for which we made a written request.
    (3) Submit annual baseline reports.
    (4) Submit supplemental reports if you obtain information that you 
did not submit in an initial report.


Sec.  803.11   What form should I use to submit reports of individual 
adverse events and where do I obtain these forms?

    If you are a user facility, importer, or manufacturer, you must 
submit all reports of individual adverse events on FDA MEDWATCH Form 
3500A or in an electronic equivalent as approved under Sec.  803.14. 
You may obtain this form and all other forms referenced in this section 
from any of the following:
    (1) The Consolidated Forms and Publications Office, Beltsville 
Service Center, 6351 Ammendale Rd., Landover, MD 20705;
    (2) Food and Drug Administration, MEDWATCH (HF-2), 5600 Fishers 
Lane, Rockville, MD 20857, 301-827-7240;
    (3) Division of Small Manufacturers, International, and Consumer 
Assistance, Office of Communication, Education, and Radiation Programs, 
Center for Devices and Radiological Health (CDRH) (HFZ-220), 1350 
Piccard Dr., Rockville, MD 20850, by e-mail: [email protected], or 
FAX: 301-443-8818; or
    (4) On the Internet at http://www.fda.gov/cdrh/mdr/mdr-forms.html.


Sec.  803.12   Where and how do I submit reports and additional 
information?

    (a) You must submit any written report or additional information 
required under this part to Food and Drug Administration, Center for 
Devices and Radiological Health, Medical Device Reporting, P.O. Box 
3002, Rockville, MD 20847-3002.
    (b) You must specifically identify each report (e.g., ``User 
Facility Report,'' ``Annual Report,'' ``Importer Report,'' 
``Manufacturer Report,'' ``10-Day Report'').
    (c) If you have a public health emergency, you can alert the FDA 
Emergency Operations Branch (HFC-162), Office of Regional Operations, 
at 301-443-1240. After contacting us, you should submit a FAX report to 
301-443-3757.
    (d) You may submit a voluntary telephone report to the MEDWATCH 
office at 800-FDA-1088. You may also obtain information regarding 
voluntary reporting from the MEDWATCH office at 800-FDA-1088. You may 
also find the voluntary MEDWATCH 3500 form and instructions to complete 
it at http://www.fda.gov/medwatch/getforms.htm.


Sec.  803.13   Do I need to submit reports in English?

    (a) Yes. You must submit all written or electronic equivalent 
reports required by this part in English.
    (b) If you submit any reports required by this part in an 
electronic medium, that submission must be done in accordance with 
Sec.  803.14.


Sec.  803.14   How do I submit a report electronically?

    (a) You may electronically submit any report required by this part 
if you have our prior written consent. We may revoke this consent at 
anytime. Electronic report submissions include alternative reporting 
media (magnetic tape, disc, etc.) and computer-to-computer 
communication.
    (b) If your electronic report meets electronic reporting standards, 
guidance documents, or other MDR reporting procedures that we have 
developed, you may submit the report electronically without receiving 
our prior written consent.


Sec.  803.15   How will I know if you require more information about my 
medical device report?

    (a) We will notify you in writing if we require additional 
information and will tell you what information we need. We will require 
additional information if we determine that protection of the public 
health requires additional or clarifying information for medical device 
reports submitted to us and in cases when the additional information is 
beyond the scope of FDA reporting forms or is not readily accessible to 
us.
    (b) In any request under this section, we will state the reason or 
purpose for the information request, specify the due date for 
submitting the information, and clearly identify the reported event(s) 
related to our request. If we verbally request additional information, 
we will confirm the request in writing.


Sec.  803.16   When I submit a report, does the information in my 
report constitute an admission that the device caused or contributed to 
the reportable event?

    No. A report or other information submitted by you, and our release 
of that report or information, is not

[[Page 9565]]

necessarily an admission that the device, or you or your employees, 
caused or contributed to the reportable event. You do not have to admit 
and may deny that the report or information submitted under this part 
constitutes an admission that the device, you, or your employees, 
caused or contributed to a reportable event.


Sec.  803.17   What are the requirements for developing, maintaining, 
and implementing written MDR procedures that apply to me?

    If you are a user facility, importer, or manufacturer, you must 
develop, maintain, and implement written MDR procedures for the 
following:
    (a) Internal systems that provide for:
    (1) Timely and effective identification, communication, and 
evaluation of events that may be subject to MDR requirements;
    (2) A standardized review process or procedure for determining when 
an event meets the criteria for reporting under this part; and
    (3) Timely transmission of complete medical device reports to 
manufacturers or to us, or to both if required.
    (b) Documentation and recordkeeping requirements for:
    (1) Information that was evaluated to determine if an event was 
reportable;
    (2) All medical device reports and information submitted to 
manufacturers and/or us;
    (3) Any information that was evaluated for the purpose of preparing 
the submission of annual reports; and
    (4) Systems that ensure access to information that facilitates 
timely followup and inspection by us.


Sec.  803.18   What are the requirements for establishing and 
maintaining MDR files or records that apply to me?

    (a) If you are a user facility, importer, or manufacturer, you must 
establish and maintain MDR event files. You must clearly identify all 
MDR event files and maintain them to facilitate timely access.
    (b)(1) For purposes of this part, ``MDR event files'' are written 
or electronic files maintained by user facilities, importers, and 
manufacturers. MDR event files may incorporate references to other 
information (e.g., medical records, patient files, engineering 
reports), in lieu of copying and maintaining duplicates in this file. 
Your MDR event files must contain:
    (i) Information in your possession or references to information 
related to the adverse event, including all documentation of your 
deliberations and decisionmaking processes used to determine if a 
device-related death, serious injury, or malfunction was or was not 
reportable under this part; and
    (ii) Copies of all MDR forms, as required by this part, and other 
information related to the event that you submitted to us and other 
entities such as an importer, distributor, or manufacturer.
    (2) If you are a user facility, importer, or manufacturer, you must 
permit any authorized FDA employee, at all reasonable times, to access, 
to copy, and to verify the records required by this part.
    (c) If you are a user facility, you must retain an MDR event file 
relating to an adverse event for a period of 2 years from the date of 
the event. If you are a manufacturer or importer, you must retain an 
MDR event file relating to an adverse event for a period of 2 years 
from the date of the event or a period of time equivalent to the 
expected life of the device, whichever is greater. If the device is no 
longer distributed, you still must maintain MDR event files for the 
time periods described in this paragraph.
    (d)(1) If you are a device distributor, you must establish and 
maintain device complaint records (files). Your records must contain 
any incident information, including any written, electronic, or oral 
communication, either received or generated by you, that alleges 
deficiencies related to the identity (e.g., labeling), quality, 
durability, reliability, safety, effectiveness, or performance of a 
device. You must also maintain information about your evaluation of the 
allegations, if any, in the incident record. You must clearly identify 
the records as device incident records and file these records by device 
name. You may maintain these records in written or electronic format. 
You must back up any file maintained in electronic format.
    (2) You must retain copies of the required device incident records 
for a period of 2 years from the date of inclusion of the record in the 
file or for a period of time equivalent to the expected life of the 
device, whichever is greater. You must maintain copies of these records 
for this period even if you no longer distribute the device.
    (3) You must maintain the device complaint files established under 
this section at your principal business establishment. If you are also 
a manufacturer, you may maintain the file at the same location as you 
maintain your complaint file under part 820 of this chapter. You must 
permit any authorized FDA employee, at all reasonable times, to access, 
to copy, and to verify the records required by this part.
    (e) If you are a manufacturer, you may maintain MDR event files as 
part of your complaint file, under part 820 of this chapter, if you 
prominently identify these records as MDR reportable events. We will 
not consider your submitted MDR report to comply with this part unless 
you evaluate an event in accordance with the quality system 
requirements described in part 820 of this chapter. You must document 
and maintain in your MDR event files an explanation of why you did not 
submit or could not obtain any information required by this part, as 
well as the results of your evaluation of each event.


Sec.  803.19   Are there exemptions, variances, or alternative forms of 
adverse event reporting requirements?

    (a) We exempt the following persons from the adverse event 
reporting requirements in this part:
    (1) A licensed practitioner who prescribes or administers devices 
intended for use in humans and manufactures or imports devices solely 
for use in diagnosing and treating persons with whom the practitioner 
has a ``physician-patient'' relationship;
    (2) An individual who manufactures devices intended for use in 
humans solely for this person's use in research or teaching and not for 
sale. This includes any person who is subject to alternative reporting 
requirements under the investigational device exemption regulations 
(described in part 812 of this chapter), which require reporting of all 
adverse device effects; and
    (3) Dental laboratories or optical laboratories.
    (b) If you are a manufacturer, importer, or user facility, you may 
request an exemption or variance from any or all of the reporting 
requirements in this part. You must submit the request to us in 
writing. Your request must include information necessary to identify 
you and the device; a complete statement of the request for exemption, 
variance, or alternative reporting; and an explanation why your request 
is justified.
    (c) If you are a manufacturer, importer, or user facility, we may 
grant in writing an exemption or variance from, or alternative to, any 
or all of the reporting requirements in this part and may change the 
frequency of reporting to quarterly, semiannually, annually or other 
appropriate time period. We may grant these modifications in response 
to your request, as described in paragraph (b) of this section, or at 
our discretion. When we grant modifications to the reporting 
requirements, we may impose other reporting requirements to ensure the 
protection of public health.
    (d) We may revoke or modify in writing an exemption, variance, or

[[Page 9566]]

alternative reporting requirement if we determine that revocation or 
modification is necessary to protect the public health.
    (e) If we grant your request for a reporting modification, you must 
submit any reports or information required in our approval of the 
modification. The conditions of the approval will replace and supersede 
the regular reporting requirement specified in this part until such 
time that we revoke or modify the alternative reporting requirements in 
accordance with paragraph (d) of this section.

Subpart B--Generally Applicable Requirements for Individual Adverse 
Event Reports


Sec.  803.20  How do I complete and submit an individual adverse event 
report?

    (a) What form must I complete and submit? There are two versions of 
the MEDWATCH form for individual reports of adverse events. If you are 
a health professional or consumer, you may use the FDA Form 3500 to 
submit voluntary reports regarding FDA-regulated products. If you are a 
user facility, importer, or manufacturer, you must use the FDA Form 
3500A to submit mandatory reports about FDA-regulated products.
    (1) If you are a user facility, importer, or manufacturer, you must 
complete the applicable blocks on the front of FDA Form 3500A. The 
front of the form is used to submit information about the patient, the 
event, the device, and the ``initial reporter'' (i.e., the first person 
or entity who reported the information to you).
    (2) If you are a user facility, importer, or manufacturer, you must 
complete the applicable blocks on the back of the form. If you are a 
user facility or importer, you must complete block F. If you are a 
manufacturer, you must complete blocks G and H. If you are a 
manufacturer, you do not have to recopy information that you received 
on a Form 3500A unless you are copying the information onto an 
electronic medium. If you are a manufacturer and you are correcting or 
supplying information that is missing from another reporter's Form 
3500A, you must attach a copy of that form to your report form. If you 
are a manufacturer and the information from another reporter's Form 
3500A is complete and correct, you may fill in the remaining 
information on the same form and submit it to us.
    (b) To whom must I submit reports and when?
    (1) If you are a user facility, you must submit MDR reports to:
    (i) The manufacturer and to us no later than 10 work days after the 
day that you become aware of information that reasonably suggests that 
a device has or may have caused or contributed to a death; or
    (ii) The manufacturer no later than 10 work days after the day that 
you become aware of information that reasonably suggests that a device 
has or may have caused or contributed to a serious injury. If the 
manufacturer is not known, you must submit this report to us.
    (2) If you are an importer, you must submit MDR reports to:
    (i) The manufacturer and to us, no later than 30 calendar days 
after the day that you become aware of information that reasonably 
suggests that a device has or may have caused or contributed to a death 
or serious injury; or
    (ii) The manufacturer, no later than 30 calendar days after 
receiving information that a device you market has malfunctioned and 
that this device or a similar device that you market would be likely to 
cause or contribute to a death or serious injury if the malfunction 
were to recur.
    (3) If you are a manufacturer, you must submit MDR reports to us:
    (i) No later than 30 days after the day that you become aware of 
information that reasonably suggests that a device may have caused or 
contributed to a death or serious injury; or
    (ii) No later than 30 days after the day that you become aware of 
information that reasonably suggests a device has malfunctioned and 
that this device or a similar device that you market would be likely to 
cause or contribute to a death or serious injury if the malfunction 
were to recur; or
    (iii) Within 5 work days if required by Sec.  803.53.
    (c) What kind of information reasonably suggests that a reportable 
event has occurred?
    (1) Any information, including professional, scientific, or medical 
facts, observations, or opinions, may reasonably suggest that a device 
has caused or may have caused or contributed to an MDR reportable 
event. An MDR reportable event is a death, a serious injury, or, if you 
are a manufacturer or importer, a malfunction that would be likely to 
cause or contribute to a death or serious injury if the malfunction 
were to recur.
    (2) If you are a user facility, importer, or manufacturer, you do 
not have to report an adverse event if you have information that would 
lead a person who is qualified to make a medical judgment reasonably to 
conclude that a device did not cause or contribute to a death or 
serious injury, or that a malfunction would not be likely to cause or 
contribute to a death or serious injury if it were to recur. Persons 
qualified to make a medical judgment include physicians, nurses, risk 
managers, and biomedical engineers. You must keep in your MDR event 
files (described in Sec.  803.18) the information that the qualified 
person used to determine whether or not a device-related event was 
reportable.


Sec.  803.21   Where can I find the reporting codes for adverse events 
that I use with medical device reports?

    (a) The MEDWATCH Medical Device Reporting Code Instruction Manual 
contains adverse event codes for use with FDA Form 3500A. You may 
obtain the coding manual from CDRH's Web site at http://www.fda.gov/cdrh/mdr/373.html; and from the Division of Small Manufacturers, 
International, and Consumer Assistance, Center for Devices and 
Radiological Health, 1350 Piccard Dr., Rockville, MD 20850, FAX: 301-
443-8818, or e-mail to [email protected].
    (b) We may sometimes use additional coding of information on the 
reporting forms or modify the existing codes. If we do make 
modifications, we will ensure that we make the new coding information 
available to all reporters.


Sec.  803.22   What are the circumstances in which I am not required to 
file a report?

    (a) If you become aware of information from multiple sources 
regarding the same patient and same reportable event, you may submit 
one medical device report.
    (b) You are not required to submit a medical device report if:
    (1) You are a user facility, importer, or manufacturer, and you 
determine that the information received is erroneous in that a device-
related adverse event did not occur. You must retain documentation of 
these reports in your MDR files for the time periods specified in Sec.  
803.18.
    (2) You are a manufacturer or importer and you did not manufacture 
or import the device about which you have adverse event information. 
When you receive reportable event information in error, you must 
forward this information to us with a cover letter explaining that you 
did not manufacture or import the device in question.

[[Page 9567]]

Subpart C--User Facility Reporting Requirements


Sec.  803.30   If I am a user facility, what reporting requirements 
apply to me?

    (a) You must submit reports to the manufacturer or to us, or both, 
as specified below:
    (1) Reports of death. You must submit a report to us as soon as 
practicable but no more than 10 work days after the day that you become 
aware of information, from any source, that reasonably suggests that a 
device has or may have caused or contributed to the death of a patient 
of your facility. You must also submit the report to the device 
manufacturer, if known. You must report information required by Sec.  
803.32 on FDA Form 3500A or an electronic equivalent approved under 
Sec.  803.14.
    (2) Reports of serious injury. You must submit a report to the 
manufacturer of the device no later than 10 work days after the day 
that you become aware of information, from any source, that reasonably 
suggests that a device has or may have caused or contributed to a 
serious injury to a patient of your facility. If the manufacturer is 
not known, you must submit the report to us. You must report 
information required by Sec.  803.32 on FDA Form 3500A or an electronic 
equivalent approved under Sec.  803.14.
    (b) What information does FDA consider ``reasonably known'' to me? 
You must submit all information required in this subpart C that is 
reasonably known to you. This information includes information found in 
documents that you possess and any information that becomes available 
as a result of reasonable followup within your facility. You are not 
required to evaluate or investigate the event by obtaining or 
evaluating information that you do not reasonably know.


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

    You must include the following information in your report, if 
reasonably known to you, as described in Sec.  803.30(b). These types 
of information correspond generally to the elements of FDA Form 3500A:
    (a) Patient information (Form 3500A, Block A). You must submit the 
following:
    (1) Patient name or other identifier;
    (2) Patient age at the time of event, or date of birth;
    (3) Patient gender; and
    (4) Patient weight.
    (b) Adverse event or product problem (Form 3500A, Block B). You 
must submit the following:
    (1) Identification of adverse event or product problem;
    (2) Outcomes attributed to the adverse event (e.g., death or 
serious injury). An outcome is considered a serious injury if it is:
    (i) Life-threatening injury or illness;
    (ii) Disability resulting in permanent impairment of a body 
function or permanent damage to a body structure; or
    (iii) Injury or illness that requires intervention to prevent 
permanent impairment of a body structure or function;
    (3) Date of event;
    (4) Date of report by the initial reporter;
    (5) Description of event or problem, including a discussion of how 
the device was involved, nature of the problem, patient followup or 
required treatment, and any environmental conditions that may have 
influenced the event;
    (6) Description of relevant tests, including dates and laboratory 
data; and
    (7) Description of other relevant history, including preexisting 
medical conditions.
    (c) Device information (Form 3500A, Block D). You must submit the 
following:
    (1) Brand name;
    (2) Type of device;
    (3) Manufacturer name and address;
    (4) Operator of the device (health professional, patient, lay user, 
other);
    (5) Expiration date;
    (6) Model number, catalog number, serial number, lot number, or 
other identifying number;
    (7) Date of device implantation (month, day, year);
    (8) Date of device explantation (month, day, year);
    (9) Whether the device was available for evaluation and whether the 
device was returned to the manufacturer; if so, the date it was 
returned to the manufacturer; and
    (10) Concomitant medical products and therapy dates. (Do not report 
products that were used to treat the event.)
    (d) Initial reporter information (Form 3500A, Block E). You must 
submit the following:
    (1) Name, address, and telephone number of the reporter who 
initially provided information to you, or to the manufacturer or 
distributor;
    (2) Whether the initial reporter is a health professional;
    (3) Occupation; and
    (4) Whether the initial reporter also sent a copy of the report to 
us, if known.
    (e) User facility information (Form 3500A, Block F). You must 
submit the following:
    (1) An indication that this is a user facility report (by marking 
the user facility box on the form);
    (2) Your user facility number;
    (3) Your address;
    (4) Your contact person;
    (5) Your contact person's telephone number;
    (6) Date that you became aware of the event (month, day, year);
    (7) Type of report (initial or followup); if it is a followup, you 
must include the report number of the initial report;
    (8) Date of your report (month, day, year);
    (9) Approximate age of device;
    (10) Event problem codes--patient code and device code (refer to 
the ``MEDWATCH Medical Device Reporting Code Instructions'');
    (11) Whether a report was sent to us and the date it was sent 
(month, day, year);
    (12) Location where the event occurred;
    (13) Whether the report was sent to the manufacturer and the date 
it was sent (month, day, year); and
    (14) Manufacturer name and address, if available.


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

    (a) You must submit to us an annual report on FDA Form 3419, or 
electronic equivalent as approved by us under Sec.  803.14. You must 
submit an annual report by January 1, of each year. You must clearly 
identify your annual report as such. Your annual report must include:
    (1) Your CMS provider number used for medical device reports, or 
the number assigned by us for reporting purposes in accordance with 
Sec.  803.3;
    (2) Reporting year;
    (3) Your name and complete address;
    (4) Total number of reports attached or summarized;
    (5) Date of the annual report and report numbers identifying the 
range of medical device reports that you submitted during the report 
period (e.g., 1234567890-2004-0001 through 1000);
    (6) Name, position title, and complete address of the individual 
designated as your contact person responsible for reporting to us and 
whether that person is a new contact for you; and
    (7) Information for each reportable event that occurred during the 
annual reporting period including:
    (i) Report number;
    (ii) Name and address of the device manufacturer;
    (iii) Device brand name and common name;
    (iv) Product model, catalog, serial and lot number;

[[Page 9568]]

    (v) A brief description of the event reported to the manufacturer 
and/or us; and
    (vi) Where the report was submitted, i.e., to the manufacturer, 
importer, or us.
    (b) In lieu of submitting the information in paragraph (a)(7) of 
this section, you may submit a copy of FDA Form 3500A, or an electronic 
equivalent approved under Sec.  803.14, for each medical device report 
that you submitted to the manufacturers and/or to us during the 
reporting period.
    (c) If you did not submit any medical device reports to 
manufacturers or us during the time period, you do not need to submit 
an annual report.

Subpart D--Importer Reporting Requirements


Sec.  803.40  If I am an importer, what kinds of individual adverse 
event reports must I submit, when must I submit them, and to whom must 
I submit them?

    (a) Reports of deaths or serious injuries. You must submit a report 
to us, and a copy of this report to the manufacturer, as soon as 
practicable but no later than 30 calendar days after the day that you 
receive or otherwise become aware of information from any source, 
including user facilities, individuals, or medical or scientific 
literature, whether published or unpublished, that reasonably suggests 
that one of your marketed devices may have caused or contributed to a 
death or serious injury. This report must contain the information 
required by Sec.  803.42, on FDA form 3500A or an electronic equivalent 
approved under Sec.  803.14.
    (b) Reports of malfunctions. You must submit a report to the 
manufacturer as soon as practicable but no later than 30 calendar days 
after the day that you receive or otherwise become aware of information 
from any source, including user facilities, individuals, or through 
your own research, testing, evaluation, servicing, or maintenance of 
one of your devices, that reasonably suggests that one of your devices 
has malfunctioned and that this device or a similar device that you 
market would be likely to cause or contribute to a death or serious 
injury if the malfunction were to recur. This report must contain 
information required by Sec.  803.42, on FDA form 3500A or an 
electronic equivalent approved under Sec.  803.14.


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

    You must include the following information in your report, if the 
information is known or should be known to you, as described in Sec.  
803.40. These types of information correspond generally to the format 
of FDA Form 3500A:
    (a) Patient information (Form 3500A, Block A). You must submit the 
following:
    (1) Patient name or other identifier;
    (2) Patient age at the time of event, or date of birth;
    (3) Patient gender; and
    (4) Patient weight.
    (b) Adverse event or product problem (Form 3500A, Block B). You 
must submit the following:
    (1) Identification of adverse event or product problem;
    (2) Outcomes attributed to the adverse event (e.g., death or 
serious injury). An outcome is considered a serious injury if it is:
    (i) Life-threatening injury or illness;
    (ii) Disability resulting in permanent impairment of a body 
function or permanent damage to a body structure; or
    (iii) Injury or illness that requires intervention to prevent 
permanent impairment of a body structure or function;
    (3) Date of event;
    (4) Date of report by the initial reporter;
    (5) Description of the event or problem, including a discussion of 
how the device was involved, nature of the problem, patient followup or 
required treatment, and any environmental conditions that may have 
influenced the event;
    (6) Description of relevant tests, including dates and laboratory 
data; and
    (7) Description of other relevant patient history, including 
preexisting medical conditions.
    (c) Device information (Form 3500A, Block D). You must submit the 
following:
    (1) Brand name;
    (2) Type of device;
    (3) Manufacturer name and address;
    (4) Operator of the device (health professional, patient, lay user, 
other);
    (5) Expiration date;
    (6) Model number, catalog number, serial number, lot number, or 
other identifying number;
    (7) Date of device implantation (month, day, year);
    (8) Date of device explanation (month, day, year);
    (9) Whether the device was available for evaluation, and whether 
the device was returned to the manufacturer, and if so, the date it was 
returned to the manufacturer; and
    (10) Concomitant medical products and therapy dates. (Do not report 
products that were used to treat the event.)
    (d) Initial reporter information (Form 3500A, Block E). You must 
submit the following:
    (1) Name, address, and telephone number of the reporter who 
initially provided information to the manufacturer, user facility, or 
distributor;
    (2) Whether the initial reporter is a health professional;
    (3) Occupation; and
    (4) Whether the initial reporter also sent a copy of the report to 
us, if known.
    (e) Importer information (Form 3500A, Block F). You must submit the 
following:
    (1) An indication that this is an importer report (by marking the 
importer box on the form);
    (2) Your importer report number;
    (3) Your address;
    (4) Your contact person;
    (5) Your contact person's telephone number;
    (6) Date that you became aware of the event (month, day, year);
    (7) Type of report (initial or followup). If it is a followup 
report, you must include the report number of your initial report;
    (8) Date of your report (month, day, year);
    (9) Approximate age of device;
    (10) Event problem codes--patient code and device code (refer to 
FDA MEDWATCH Medical Device Reporting Code Instructions);
    (11) Whether a report was sent to us and the date it was sent 
(month, day, year);
    (12) Location where event occurred;
    (13) Whether a report was sent to the manufacturer and the date it 
was sent (month, day, year); and
    (14) Manufacturer name and address, if available.

Subpart E--Manufacturer Reporting Requirements


Sec.  803.50   If I am a manufacturer, what reporting requirements 
apply to me?

    (a) If you are a manufacturer, you must report to us no later than 
30 calendar days after the day that you receive or otherwise become 
aware of information, from any source, that reasonably suggests that a 
device that you market:
    (1) May have caused or contributed to a death or serious injury; or
    (2) Has malfunctioned and this device or a similar device that you 
market would be likely to cause or contribute to a death or serious 
injury, if the malfunction were to recur.
    (b) What information does FDA consider ``reasonably known'' to me?
    (1) You must submit all information required in this subpart E that 
is

[[Page 9569]]

reasonably known to you. We consider the following information to be 
reasonably known to you:
    (i) Any information that you can obtain by contacting a user 
facility, importer, or other initial reporter;
    (ii) Any information in your possession; or
    (iii) Any information that you can obtain by analysis, testing, or 
other evaluation of the device.
    (2) You are responsible for obtaining and submitting to us 
information that is incomplete or missing from reports submitted by 
user facilities, importers, and other initial reporters.
    (3) You are also responsible for conducting an investigation of 
each event and evaluating the cause of the event. If you cannot submit 
complete information on a report, you must provide a statement 
explaining why this information was incomplete and the steps you took 
to obtain the information. If you later obtain any required information 
that was not available at the time you filed your initial report, you 
must submit this information in a supplemental report under Sec.  
803.56.


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

    You must include the following information in your reports, if 
known or reasonably known to you, as described in Sec.  803.50(b). 
These types of information correspond generally to the format of FDA 
Form 3500A:
    (a) Patient information (Form 3500A, Block A). You must submit the 
following:
    (1) Patient name or other identifier;
    (2) Patient age at the time of event, or date of birth;
    (3) Patient gender; and
    (4) Patient weight.
    (b) Adverse event or product problem (Form 3500A, Block B). You 
must submit the following:
    (1) Identification of adverse event or product problem;
    (2) Outcomes attributed to the adverse event (e.g., death or 
serious injury). An outcome is considered a serious injury if it is:
    (i) Life-threatening injury or illness;
    (ii) Disability resulting in permanent impairment of a body 
function or permanent damage to a body structure; or
    (iii) Injury or illness that requires intervention to prevent 
permanent impairment of a body structure or function;
    (3) Date of event;
    (4) Date of report by the initial reporter;
    (5) Description of the event or problem, including a discussion of 
how the device was involved, nature of the problem, patient followup or 
required treatment, and any environmental conditions that may have 
influenced the event;
    (6) Description of relevant tests, including dates and laboratory 
data; and
    (7) Other relevant patient history including preexisting medical 
conditions.
    (c) Device information (Form 3500A, Block D). You must submit the 
following:
    (1) Brand name;
    (2) Type of device;
    (3) Your name and address;
    (4) Operator of the device (health professional, patient, lay user, 
other);
    (5) Expiration date;
    (6) Model number, catalog number, serial number, lot number, or 
other identifying number;
    (7) Date of device implantation (month, day, year);
    (8) Date of device explantation (month, day, year);
    (9) Whether the device was available for evaluation, and whether 
the device was returned to you, and if so, the date it was returned to 
you; and
    (10) Concomitant medical products and therapy dates. (Do not report 
products that were used to treat the event.)
    (d) Initial reporter information (Form 3500A, Block E). You must 
submit the following:
    (1) Name, address, and phone number of the reporter who initially 
provided information to you, or to the user facility or importer;
    (2) Whether the initial reporter is a health professional;
    (3) Occupation; and
    (4) Whether the initial reporter also sent a copy of the report to 
us, if known.
    (e) Reporting information for all manufacturers (Form 3500A, Block 
G). You must submit the following:
    (1) Your reporting office's contact name and address and device 
manufacturing site;
    (2) Your telephone number;
    (3) Your report sources;
    (4) Date received by you (month, day, year);
    (5) Type of report being submitted (e.g., 5-day, initial, 
followup); and
    (6) Your report number.
    (f) Device manufacturer information (Form 3500A, Block H). You must 
submit the following:
    (1) Type of reportable event (death, serious injury, malfunction, 
etc.);
    (2) Type of followup report, if applicable ( e.g., correction, 
response to FDA request, etc);
    (3) If the device was returned to you and evaluated by you, you 
must include a summary of the evaluation. If you did not perform an 
evaluation, you must explain why you did not perform an evaluation;
    (4) Device manufacture date (month, day, year);
    (5) Whether the device was labeled for single use;
    (6) Evaluation codes (including event codes, method of evaluation, 
result, and conclusion codes) (refer to FDA MEDWATCH Medical Device 
Reporting Code Instructions);
    (7) Whether remedial action was taken and the type of action;
    (8) Whether the use of the device was initial, reuse, or unknown;
    (9) Whether remedial action was reported as a removal or correction 
under section 519(f) of the act, and if it was, provide the correction/
removal report number; and
    (10) Your additional narrative; and/or
    (11) Corrected data, including:
    (i) Any information missing on the user facility report or importer 
report, including any event codes that were not reported, or 
information corrected on these forms after your verification;
    (ii) For each event code provided by the user facility under Sec.  
803.32(e)(10) or the importer under Sec.  803.42(e)(10), you must 
include a statement of whether the type of the event represented by the 
code is addressed in the device labeling; and
    (iii) If your report omits any required information, you must 
explain why this information was not provided and the steps taken to 
obtain this information.


Sec.  803.53  If I am a manufacturer, in which circumstances must I 
submit a 5-day report?

    You must submit a 5-day report to us, on Form 3500A or an 
electronic equivalent approved under Sec.  803.14, no later than 5 work 
days after the day that you become aware that:
    (a) An MDR reportable event necessitates remedial action to prevent 
an unreasonable risk of substantial harm to the public health. You may 
become aware of the need for remedial action from any information, 
including any trend analysis; or
    (b) We have made a written request for the submission of a 5-day 
report. If you receive such a written request from us, you must submit, 
without further requests, a 5-day report for all subsequent events of 
the same nature that involve substantially similar devices for the time 
period specified in the written request. We may extend the time period 
stated in the original written request if we determine it is in the 
interest of the public health.

[[Page 9570]]

Sec.  803.55   If I am a manufacturer, in what circumstances must I 
submit a baseline report, and what are the requirements for such a 
report?

    (a) You must submit a baseline report for a device when you submit 
the first report under Sec.  803.50 involving that device model. Submit 
this report on FDA Form 3417 or an electronic equivalent approved under 
Sec.  803.14.
    (b) You must update each baseline report annually on the 
anniversary month of the initial submission, after the initial baseline 
report is submitted. Report changes to baseline information in the 
manner described in Sec.  803.56 (i.e., include only the new, changed, 
or corrected information in the appropriate portion(s) of the report 
form). In each baseline report, you must include the following 
information:
    (1) Name, complete address, and establishment registration number 
of your reporting site. If your reporting site is not registered under 
part 807, we will assign a temporary number for use in MDR reporting 
until you register your reporting site in accordance with part 807. We 
will inform you of the temporary MDR reporting number;
    (2) FDA registration number of each site where you manufacture the 
device;
    (3) Name, complete address, and telephone number of the individual 
who you have designated as your MDR contact, and the date of the 
report. For foreign manufacturers, we require a confirmation that the 
individual submitting the report is the agent of the manufacturer 
designated under Sec.  803.58(a);
    (4) Product identification, including device family, brand name, 
generic name, model number, catalog number, product code, and any other 
product identification number or designation;
    (5) Identification of any device that you previously reported in a 
baseline report that is substantially similar (e.g., same device with a 
different model number, or same device except for cosmetic differences 
in color or shape) to the device being reported. This includes 
additional identification of the previously reported device by model 
number, catalog number, or other product identification, and the date 
of the baseline report for the previously reported device;
    (6) Basis for marketing, including your 510(k) premarket 
notification number or PMA number, if applicable, and whether the 
device is currently the subject of an approved postmarket study under 
section 522 of the act;
    (7) Date that you initially marketed the device and, if applicable, 
the date on which you stopped marketing the device;
    (8) Shelf life of the device, if applicable, and expected life of 
the device;
    (9) The number of devices manufactured and distributed in the last 
12 months and an estimate of the number of devices in current use; and
    (10) Brief description of any methods that you used to estimate the 
number of devices distributed and the number of devices in current use. 
If this information was provided in a previous baseline report, in lieu 
of resubmitting the information, it may be referenced by providing the 
date and product identification for the previous baseline report.


Sec.  803.56  If I am a manufacturer, in what circumstances must I 
submit a supplemental or followup report and what are the requirements 
for such reports?

    If you are a manufacturer, when you obtain information required 
under this part that you did not provide because it was not known or 
was not available when you submitted the initial report, you must 
submit the supplemental information to us within 1 month of the day 
that you receive this information. On a supplemental or followup 
report, you must:
    (a) Indicate on the envelope and in the report that the report 
being submitted is a supplemental or followup report. If you are using 
FDA form 3500A, indicate this in Block Item H-2;
    (b) Submit the appropriate identification numbers of the report 
that you are updating with the supplemental information (e.g., your 
original manufacturer report number and the user facility or importer 
report number of any report on which your report was based), if 
applicable; and
    (c) Include only the new, changed, or corrected information in the 
appropriate portion(s) of the respective form(s) for reports that cross 
reference previous reports.


Sec.  803.58   Foreign manufacturers.

    (a) Every foreign manufacturer whose devices are distributed in the 
United States shall designate a U.S. agent to be responsible for 
reporting in accordance with Sec.  807.40 of this chapter. The U.S. 
designated agent accepts responsibility for the duties that such 
designation entails. Upon the effective date of this regulation, 
foreign manufacturers shall inform FDA, by letter, of the name and 
address of the U.S. agent designated under this section and Sec.  
807.40 of this chapter, and shall update this information as necessary. 
Such updated information shall be submitted to FDA, within 5 days of a 
change in the designated agent information.
    (b) U.S.-designated agents of foreign manufacturers are required 
to:
    (1) Report to FDA in accordance with Sec. Sec.  803.50, 803.52, 
803.53, 803.55, and 803.56;
    (2) Conduct, or obtain from the foreign manufacturer the necessary 
information regarding, the investigation and evaluation of the event to 
comport with the requirements of Sec.  803.50;
    (3) Forward MDR complaints to the foreign manufacturer and maintain 
documentation of this requirement;
    (4) Maintain complaint files in accordance with Sec.  803.18; and
    (5) Register, list, and submit premarket notifications in 
accordance with part 807 of this chapter.

    Dated: February 17, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-3833 Filed 2-25-05; 8:45 am]
BILLING CODE 4160-01-S