81 FR 46694 - Refurbishing, Reconditioning, Rebuilding, Remarketing, Remanufacturing, and Servicing of Medical Devices Performed by Third-Party Entities and Original Equipment Manufacturers; Public Workshop

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 137 (July 18, 2016)

Page Range		46694-46695
FR Document		2016-16887

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.

Federal Register, Volume 81 Issue 137 (Monday, July 18, 2016)

[Federal Register Volume 81, Number 137 (Monday, July 18, 2016)]
[Notices]
[Pages 46694-46695]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-16887]


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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.

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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, [email protected].

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: [email protected], 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

46694 Federal Register / Vol. 81, No. 137 / Monday, July 18, 2016 / Notices

‘‘insignificant risk of an erroneous MedicalDevices/ drawn from the flex studies; a
result’’ may obtain a certificate of DeviceRegulationandGuidance/ description of fail-safe and failure alert
waiver (42 U.S.C. 263a(d)(2)). The GuidanceDocuments/ucm079632.htm). mechanisms and a description of the
Secretary has delegated to FDA the This guidance document describes studies validating these mechanisms; a
authority to determine whether recommendations for device description of clinical tests that
particular tests (waived tests) are manufacturers submitting to FDA an demonstrate the accuracy of the test in
‘‘simple’’ and have ‘‘an insignificant risk application for determination that a the hands of intended operators; and
of an erroneous result’’ under CLIA (69 cleared or approved device meets this statistical analyses of clinical study
FR 22849, April 27, 2004). CLIA standard (CLIA waiver results.
On January 30, 2008, FDA published application). The guidance recommends In the Federal Register of April 1,
a guidance document entitled that CLIA waiver applications include a 2016 (81 FR 18858), FDA published a
‘‘Guidance for Industry and FDA Staff: description of the features of the device 60-day notice requesting public
Recommendations for Clinical that make it ‘‘simple’’; a report comment on the proposed collection of
Laboratory Improvement Amendments describing a hazard analysis that information. No comments were
of 1988 (CLIA) Waiver Applications for identifies potential sources of error, received.
Manufacturers of In Vitro Diagnostic including a summary of the design and FDA estimates the burden of this
Devices’’ (http://www.fda.gov/ results of flex studies and conclusions collection of information as follows:

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Total operating
Number of Average
Number of Total annual and
Activity responses per burden per Total hours
respondents responses maintenance
respondent response costs

CLIA waiver application ........................... 40 1 40 1,200 48,000 $350,000
1 There are no capital costs associated with this collection of information.

TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Number of Average
Number of Total annual
Activity records per burden per Total hours
recordkeepers records
recordkeeper recordkeeping

CLIA waiver records ............................................................ 40 1 40 2,800 112,000
1 There are no capital costs or operating and maintenance costs associated with this collection of information.

The total number of reporting and specimen collection for study as well as Remanufacturing, and Servicing of
recordkeeping hours is 160,000 hours. shipping and supplies). Medical Devices Performed by Third-
FDA bases the burden on an Agency Dated: July 13, 2016. Party Entities and Original Equipment
analysis of premarket submissions with Leslie Kux,
Manufacturers.’’ The topics to be
clinical trials similar to the waived discussed are the current regulatory
Associate Commissioner for Policy.
laboratory tests. Based on previous environment for these activities, the
[FR Doc. 2016–16886 Filed 7–15–16; 8:45 am]
years’ experience with CLIA waiver definitions of the various terms FDA
BILLING CODE 4164–01–P proposed in the prior Federal Register
applications, FDA expects 40
manufacturers to submit one CLIA notice on this subject, and whether
waiver application per year. The time these activities should appropriately be
DEPARTMENT OF HEALTH AND
required to prepare and submit a waiver regulated by FDA or a non-
HUMAN SERVICES
application, including the time needed governmental organization.
to assemble supporting data, averages Food and Drug Administration DATES: The public workshop will be
1,200 hours per waiver application for held on October 27, 2016, from 8:30
[Docket No. FDA–2016–N–0001] a.m. to 5 p.m. and October 28, 2016,
a total of 48,000 hours for reporting.
Based on previous years’ experience from 8:30 a.m. to 4 p.m.
Refurbishing, Reconditioning,
with CLIA waiver applications, FDA ADDRESSES: The public workshop will
Rebuilding, Remarketing,
expects that each manufacturer will be held at FDA’s White Oak Campus,
Remanufacturing, and Servicing of
spend 2,800 hours creating and 10903 New Hampshire Ave., Bldg. 31
Medical Devices Performed by Third-
maintaining the record for a total of Conference Center, the Great Room (Rm.
Party Entities and Original Equipment
112,000 hours. 1503), Silver Spring, MD 20993–0002.
Manufacturers; Public Workshop
Entrance for the public workshop
The total operating and maintenance Food and Drug Administration, participants (non-FDA employees) is
asabaliauskas on DSK3SPTVN1PROD with NOTICES

AGENCY:
cost associated with the waiver HHS. through Building 1, where routine
application is estimated at $350,000. security check procedures will be
ACTION: Notice of public workshop.
This cost is largely attributed to clinical performed. For parking and security
study costs incurred, which include site SUMMARY: The Food and Drug information, please refer to http://
selection and qualification, protocol Administration (FDA) is announcing the www.fda.gov/AboutFDA/
review, and study execution (initiation, following public workshop entitled WorkingatFDA/BuildingsandFacilities/
monitoring, closeout, and clinical site/ ‘‘Refurbishing, Reconditioning, WhiteOakCampusInformation/
subject compensation—including Rebuilding, Remarketing, ucm241740.htm.

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Document Created: 2016-07-16 02:28:41
Document Modified: 2016-07-16 02:28:41

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice of public workshop.
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.
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, [email protected]
FR Citation		81 FR 46694

81 FR 46694 - Refurbishing, Reconditioning, Rebuilding, Remarketing, Remanufacturing, and Servicing of Medical Devices Performed by Third-Party Entities and Original Equipment Manufacturers; Public Workshop

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 81, Issue 137 (July 18, 2016)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration