[Federal Register Volume 81, Number 43 (Friday, March 4, 2016)]
[Proposed Rules]
[Pages 11477-11479]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-04700]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 820

[Docket No. FDA-2016-N-0436]


Refurbishing, Reconditioning, Rebuilding, Remarketing, 
Remanufacturing, and Servicing of Medical Devices Performed by Third-
Party Entities and Original Equipment Manufacturers; Request for 
Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notification; request for comments.

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SUMMARY: The Food and Drug Administration (FDA or we) is announcing the 
establishment of a docket to receive information and comments on the 
medical device industry and healthcare community that refurbish, 
recondition, rebuild, remarket, remanufacture, service, and repair 
medical devices (hereafter termed ``third-party entity or entities''), 
including radiation-emitting devices subject to the electronic product 
radiation control (EPRC) provisions of the Federal Food, Drug, and 
Cosmetic Act (the FD&C Act). FDA is taking this action, in part, 
because various stakeholders have expressed concerns about the quality, 
safety, and continued effectiveness of medical devices that have been 
subject to one or more of these activities that are performed by both 
original equipment manufacturers (OEM) and third parties, including 
health care establishments. We are seeking comments from the widest 
range of interested persons, including those who are engaged in one or 
more of the activities noted previously or who utilize refurbished, 
reconditioned, rebuilt, remarketed, remanufactured, or third-party 
serviced and repaired medical devices.

DATES: Submit either electronic or written comments by May 3, 2016.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to http://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on http://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Division of Dockets Management (HFA-305), Food

[[Page 11478]]

and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 
20852.
     For written/paper comments submitted to the Division of 
Dockets Management, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2016-N-0436 for ``Refurbishing, Reconditioning, Rebuilding, 
Remarketing, Remanufacturing, and Servicing of Medical Devices 
Performed by Third-Party Entities and Original Equipment Manufacturers; 
Request for Comments.'' Received comments will be placed in the docket 
and, except for those submitted as ``Confidential Submissions,'' 
publicly viewable at http://www.regulations.gov or at the Division of 
Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on http://www.regulations.gov. 
Submit both copies to the Division of Dockets Management. If you do not 
wish your name and contact information to be made publicly available, 
you can provide this information on the cover sheet and not in the body 
of your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper 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: Valerie Flournoy, Center for Devices 
and Radiological Health, Food and Drug Administration, 10903 New 
Hampshire Ave., Silver Spring, MD 20993-0002, 301-796-5495.

SUPPLEMENTARY INFORMATION: 

I. Background

    Over the past 20 years, the Center for Devices and Radiological 
Health has sought to clarify our regulatory requirements and 
expectations, under part 820 (21 CFR part 820), to entities servicing, 
refurbishing, rebuilding, reconditioning, remarketing, and 
remanufacturing medical devices. In addition, FDA medical device 
regulations include requirements that device manufacturers establish 
and maintain instructions and procedures for servicing. However, in the 
Federal Register on December 4, 1998 (63 FR 67076), refurbishers and 
servicers of medical devices were excluded from the requirement to 
comply with the 1997 Quality System Regulation under part 820.
    Moreover, EPRC requirements of the FD&C Act (Pub. L. 90-602, 
amended by Pub. L. 103-80), include provisions specific to 
manufacturers and assemblers of certified x-ray components. Under Sec.  
1020.30(c) (21 CFR 1020.30(c)), manufacturers of diagnostic x-ray 
systems are responsible for providing assembly instructions adequate to 
assure compliance of their components with the applicable performance 
standards when installed properly. Furthermore, under Sec.  1020.30(d), 
assemblers are then required to assemble, install, adjust, and test the 
certified components according to the instructions of their respective 
manufacturers.
    FDA has previously issued guidance on these topics, including an 
Assembler's Guide to Diagnostic X-ray Equipment (Ref. 1) and 
Information Disclosure by Manufacturers to Assemblers for Diagnostic X-
ray Systems (Ref. 2). Under the EPRC provision in 21 CFR 
1040.10(h)(1)(i), manufacturers of laser products are required to 
provide instructions for assembly, operation, and maintenance, 
including warnings and precautions on how to avoid exposure, and 
maintenance schedules to ensure product complies with requirements in 
the standard.
    Stakeholders have expressed concerns that some third-party entities 
who refurbish, recondition, rebuild, remarket, remanufacture, service, 
and repair medical devices may use unqualified personnel to perform 
service, maintenance, refurbishment, and device alterations on their 
equipment and that the work performed may not be adequately documented. 
Possible public health issues arising from these activities include 
ineffective recalls, disabled device safety features, and improper or 
unexpected device operation. OEMs have also requested clarification of 
their responsibilities when their devices have been altered by a third-
party entity. Federal Agencies other than FDA address service and 
maintenance activities as well.
    FDA is interested in comments concerning the service, maintenance, 
refurbishment, and alteration of medical devices, including endoscopes 
(Ref. 3), by third-party entities. In addition, we want to know more 
about the challenges third-party entities face in maintaining or 
restoring devices to their original or current specifications. This 
docket is not intended to address the reprocessing of single-use or 
reusable medical devices.
    FDA intends to hold a public meeting later in 2016 to further 
engage this segment of the device industry and healthcare community. 
The comments submitted to this docket will help inform the content of 
the public meeting.

II. Issues for Consideration

A. Proposed Definitions of Third-Party and OEM Activities

    FDA is asking for assistance in defining the following terms 
specific to this document. These terms, while not an exhaustive list, 
should capture and encompass most of the activities performed on 
medical devices. While we suggest language for each term, we are 
inviting interested persons to suggest revisions and any additional 
terms that may help define third-party and OEM activities including 
additional activities that are not encompassed by the following 
suggested terms and all-encompassing terms that can include some or all 
of the activities discussed in this section II.A.
    1. Recondition: Restores and/or refurbishes a medical device to the 
OEM's original specifications. Under limited circumstances the medical 
device may be restored and/or refurbished to current specifications.
    2. Service: Maintenance or repair of a finished device after 
distribution for purposes of returning it to the safety and performance 
specifications established by the OEM and to meet its original

[[Page 11479]]

intended use. Servicing cannot change the intended use(s) of the device 
from its original purpose(s).
    3. Repair: Return the device or component to original 
specifications including replacing non-working components or parts 
outside of routine or periodic upkeep for the current owner of the 
device.
    4. Refurbish: Restore device to a condition of safety and 
effectiveness that is comparable to when new. This includes 
reconditioning, repair, installation of certain software/hardware 
updates that do not change the intended use of the original device, and 
replacement of worn parts.
    5. Remanufacture: Process, condition, renovate, repackage, restore, 
or any other act done to a finished device that significantly changes 
the finished device's performance, safety specifications, or intended 
use.
    6. Remarket: The act of facilitating the transfer of a previously 
owned device from one party to another by sale, donation, gift, or 
lease.

B. Evaluation of Risk Associated With These Third-Party and OEM 
Activities

    In addition to obtaining comments that define the key terms 
applicable to this issue, FDA believes that a need exists for 
interested persons to comment on the benefits and risks related to the 
previously defined activities. We invite interested persons to comment 
on the following questions:
    1. Who are the different stakeholders involved with the medical 
device activities listed previously? What are their respective roles?
    2. What evidence exists regarding actual problems with the safety 
and/or performance of devices that result from these activities? 
Specific examples should be submitted.
    3. What are the potential risks (patients/users) and failure modes 
(devices) introduced as a result of performing the previously defined 
activities on medical devices? Please speak to issues common to all 
devices as well as specific risks with specific devices.
    4. These activities are performed by OEMs and various third-party 
entities, including hospitals and humanitarian organizations. Are the 
risks different depending on who performs the previously mentioned 
activities?
    5. We are interested in knowing if these activities are more 
difficult or riskier to perform on certain devices versus others. 
Please cite specific examples in your response, along with an 
explanation of the source of this particular complexity.
    6. What information do third-party entities need in order to 
perform these activities in a way that results in safe and effective 
operation of the medical device? Please provide specific examples.
    7. What additional challenges do stakeholders encounter with 
devices that result from these activities?

III. Paperwork Reduction Act of 1995

    This document refers to previously approved collections of 
information found in FDA regulations. These collections of information 
are subject to review by the Office of Management and Budget (OMB) 
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The 
collections of information in 21 CFR part 820 have been approved under 
OMB control number 0910-0073; the collections of information in 21 CFR 
parts 1020 and 1040 have been approved under OMB control number 0910-
0025.

IV. References

    The following references are on display in the Division of Dockets 
Management (see ADDRESSES) and are available for viewing by interested 
persons between 9 a.m. and 4 p.m., Monday through Friday; they are also 
available electronically at http://www.regulations.gov. FDA has 
verified the Web site addresses, as of the date this document publishes 
in the Federal Register, but Web sites are subject to change over time.

1. Guidance for Industry and Food and Drug Administration Staff on 
Assembler's Guide to Diagnostic X-Ray Equipment. Available at http://www.fda.gov/downloads/MedicalDevices/.../UCM257783.pdf.
2. Guidance for Industry and FDA Staff on Information Disclosure by 
Manufacturers to Assemblers for Diagnostic X-ray Systems. Available 
at http://www.fda.gov/downloads/Radiation-EmittingProducts/ElectronicProductRadiationControlProgram/IndustryGuidance/UCM136731.pdf.
3. FDA Executive Summary: Effective Reprocessing of Endoscopes Used 
in Endoscopic Retrograde Cholangiopancreatography (ERCP) Procedures, 
FDA. Available at http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/Gastroenterology-UrologyDevicesPanel/UCM445592.pdf.


    Dated: February 26, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-04700 Filed 3-3-16; 8:45 am]
 BILLING CODE 4164-01-P