Document ID: FDA-2016-N-0001-0082
Agency: fda
Document Type: Notice
Title: Refurbishing, Reconditioning, Rebuilding, Remarketing,  Remanufacturing, and Servicing of Medical Devices Performed by Third-Party Entities and Original Equipment Manufacturers; Public Workshop
Posted Date: 2016-07-18T04:00Z

[Federal Register Volume 81, Number 137 (Monday, July 18, 2016)]
[Notices]
[Pages 46694-46695]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-16887]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-N-0001]

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

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the 
following public workshop entitled ``Refurbishing, Reconditioning, 
Rebuilding, Remarketing, Remanufacturing, and Servicing of Medical 
Devices Performed by Third-Party Entities and Original Equipment 
Manufacturers.'' The topics to be discussed are the current regulatory 
environment for these activities, the definitions of the various terms 
FDA proposed in the prior Federal Register notice on this subject, and 
whether these activities should appropriately be regulated by FDA or a 
non-governmental organization.

DATES: The public workshop will be held on October 27, 2016, from 8:30 
a.m. to 5 p.m. and October 28, 2016, from 8:30 a.m. to 4 p.m.

ADDRESSES: The public workshop will be held at FDA's White Oak Campus, 
10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room 
(Rm. 1503), Silver Spring, MD 20993-0002. Entrance for the public 
workshop participants (non-FDA employees) is through Building 1, where 
routine security check procedures will be performed. For parking and 
security information, please refer to http://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm.

[[Page 46695]]

FOR FURTHER INFORMATION CONTACT: Felicia Brayboy, Center for Devices 
and Radiological Health, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 66, Rm. 3464, Silver Spring, MD 20993, 301-796-
8086, Felicia.Brayboy@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: 

I. Background

    On March 4, 2016, FDA published in the Federal Register a notice 
(81 FR 11477) requesting comments from interested persons, including 
those engaged or otherwise interested in the ``Refurbishing, 
Reconditioning, Rebuilding, Remarketing, Remanufacturing, and Servicing 
of Medical Devices,'' including radiation-emitting devices subject to 
the electronic product radiation control provisions of the Federal 
Food, Drug, and Cosmetic Act. FDA took 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. This docket asked that interested 
persons, including Original equipment manufacturers (OEMs), health care 
establishments, and third-party entities review proposed terms and 
definitions and provide edits if applicable. The docket also sought 
insights into basic concepts with regard to these activities. FDA is 
currently reviewing all of the comments and will use them to inform a 
set of working questions designed to promote an understanding of 
challenges and best practices to mitigate risks associated with these 
activities. These working questions will be addressed in group 
discussions on both days of the workshop.

II. Topics for Discussion at the Public Workshop

    The public workshop sessions will incorporate the following general 
themes pertaining to the refurbishing, reconditioning, rebuilding, 
remarketing, remanufacturing, and servicing of medical devices:
     Establish working definitions for third-party and OEM 
activities.
     Discuss benefits and challenges that stakeholders 
encounter, potential benefits and risks to patients/users, and failure 
modes of devices introduced as a result of performing activities 
associated with third-party entities.
     Identify current best practices and discuss alternative 
methods to mitigate risks associated with performing activities 
associated with third-party entities.
     Determine whether specific procedures are necessary for 
each activity as it relates to third-party services performed.
    Registration: Registration is free and available on a first-come, 
first-served basis. Persons interested in attending this public 
workshop must register online by September 23, 2016, by 4 p.m. Early 
registration is recommended because facilities are limited and, 
therefore, FDA may limit the number of participants from each 
organization. If time and space permits, onsite registration on the day 
of the public workshop; will be provided beginning at 7:30 a.m.
    If you need special accommodations due to a disability, please 
contact Peggy Roney, Office of Communication, Education, and Radiation 
Programs, 301-796-5671, email: Peggy.roney@fda.hhs.gov, no later than 
October 13, 2016.
    To register for the public workshop, please visit FDA's Medical 
Devices News & Events--Workshops & Conferences calendar at http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/default.htm. 
(Select this meeting/public workshop from the posted events list.) 
Please provide complete contact information for each attendee, 
including name, title, affiliation, address, email, and telephone 
number. Those without Internet access should contact Peggy Roney to 
register (see special accomodations contact). Registrants will receive 
confirmation after they have been accepted. You will be notified if you 
are on a waiting list.
    Streaming Webcast of the Public Workshop: This public workshop will 
also be Webcast. The Webcast link will be available on the registration 
Web page after October 20, 2016. If you have never attended a Connect 
Pro event before, test your connection at https://collaboration.fda.gov/common/help/en/support/meeting_test.htm. To get a 
quick overview of the Connect Pro program, visit http://www.adobe.com/go/connectpro_overview. FDA has verified the Web site addresses in this 
document, as of the date this document publishes in the Federal 
Register, but Web sites are subject to change over time.
    Requests for Oral Presentations: This public workshop includes a 
public comment session and topic-focused sessions. During online 
registration you may indicate if you wish to present during a public 
comment session or participate in a specific session, and which topics 
you wish to address. FDA has included general topics in this document. 
FDA will do its best to accommodate requests to make public comments 
and participate in the focused sessions. Individuals and organizations 
with common interests are urged to consolidate or coordinate their 
presentations, and request time for a joint presentation, or submit 
requests for designated representatives to participate in the focused 
sessions. Following the close of registration, FDA will determine the 
amount of time allotted to each presenter and the approximate time each 
oral presentation is to begin, and will select and notify participants 
by September 30, 2016. All requests to make oral presentations must be 
received by the close of registration on September 23, 2016, by 4 p.m. 
(EDT). If selected as a presenter, any presentation materials must be 
emailed to Felicia Brayboy (see FOR FURTHER INFORMATION CONTACT) no 
later than October 13, 2016. No commercial or promotional material will 
be permitted to be presented or distributed at the public workshop.
    Transcripts: Please be advised that as soon as a transcript is 
available, it will be accessible at http://www.regulations.gov. It may 
be viewed at the Division of Dockets Management (see ADDRESSES). A 
transcript will also be available in either hardcopy or on CD-ROM, 
after submission of a Freedom of Information request. The Freedom of 
Information office address is available on the Agency's Web site at 
http://www.fda.gov. A link to the transcripts will also be available 
approximately 45 days after the public workshop on the Internet at 
http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/default.htm. (Select this public workshop from the posted events list).

    Dated: July 13, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-16887 Filed 7-15-16; 8:45 am]
 BILLING CODE 4164-01-P