Refurbishing, Reconditioning, Rebuilding, Remarketing, Remanufacturing, and Servicing of Medical Devices Performed by Third-Party Entities and Original Equipment Manufacturers; Public Workshop, 46694-46695 [2016-16887]
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46694
Federal Register / Vol. 81, No. 137 / Monday, July 18, 2016 / Notices
‘‘insignificant risk of an erroneous
result’’ may obtain a certificate of
waiver (42 U.S.C. 263a(d)(2)). The
Secretary has delegated to FDA the
authority to determine whether
particular tests (waived tests) are
‘‘simple’’ and have ‘‘an insignificant risk
of an erroneous result’’ under CLIA (69
FR 22849, April 27, 2004).
On January 30, 2008, FDA published
a guidance document entitled
‘‘Guidance for Industry and FDA Staff:
Recommendations for Clinical
Laboratory Improvement Amendments
of 1988 (CLIA) Waiver Applications for
Manufacturers of In Vitro Diagnostic
Devices’’ (https://www.fda.gov/
MedicalDevices/
DeviceRegulationandGuidance/
GuidanceDocuments/ucm079632.htm).
This guidance document describes
recommendations for device
manufacturers submitting to FDA an
application for determination that a
cleared or approved device meets this
CLIA standard (CLIA waiver
application). The guidance recommends
that CLIA waiver applications include a
description of the features of the device
that make it ‘‘simple’’; a report
describing a hazard analysis that
identifies potential sources of error,
including a summary of the design and
results of flex studies and conclusions
drawn from the flex studies; a
description of fail-safe and failure alert
mechanisms and a description of the
studies validating these mechanisms; a
description of clinical tests that
demonstrate the accuracy of the test in
the hands of intended operators; and
statistical analyses of clinical study
results.
In the Federal Register of April 1,
2016 (81 FR 18858), FDA published a
60-day notice requesting public
comment on the proposed collection of
information. No comments were
received.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Activity
Number of
respondents
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
Total hours
Total operating
and
maintenance
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
Activity
Number of
recordkeepers
Number of
records per
recordkeeper
Total annual
records
Average
burden per
recordkeeping
Total hours
CLIA waiver records ............................................................
40
1
40
2,800
112,000
asabaliauskas on DSK3SPTVN1PROD with NOTICES
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
The total number of reporting and
recordkeeping hours is 160,000 hours.
FDA bases the burden on an Agency
analysis of premarket submissions with
clinical trials similar to the waived
laboratory tests. Based on previous
years’ experience with CLIA waiver
applications, FDA expects 40
manufacturers to submit one CLIA
waiver application per year. The time
required to prepare and submit a waiver
application, including the time needed
to assemble supporting data, averages
1,200 hours per waiver application for
a total of 48,000 hours for reporting.
Based on previous years’ experience
with CLIA waiver applications, FDA
expects that each manufacturer will
spend 2,800 hours creating and
maintaining the record for a total of
112,000 hours.
The total operating and maintenance
cost associated with the waiver
application is estimated at $350,000.
This cost is largely attributed to clinical
study costs incurred, which include site
selection and qualification, protocol
review, and study execution (initiation,
monitoring, closeout, and clinical site/
subject compensation—including
VerDate Sep<11>2014
17:52 Jul 15, 2016
Jkt 238001
specimen collection for study as well as
shipping and supplies).
Dated: July 13, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–16886 Filed 7–15–16; 8:45 am]
BILLING CODE 4164–01–P
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 ThirdParty Entities and Original Equipment
Manufacturers; Public Workshop
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of public workshop.
The Food and Drug
Administration (FDA) is announcing the
following public workshop entitled
‘‘Refurbishing, Reconditioning,
Rebuilding, Remarketing,
SUMMARY:
PO 00000
Frm 00055
Fmt 4703
Sfmt 4703
Remanufacturing, and Servicing of
Medical Devices Performed by ThirdParty 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 nongovernmental 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 https://
www.fda.gov/AboutFDA/
WorkingatFDA/BuildingsandFacilities/
WhiteOakCampusInformation/
ucm241740.htm.
E:\FR\FM\18JYN1.SGM
18JYN1
Federal Register / Vol. 81, No. 137 / Monday, July 18, 2016 / Notices
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 radiationemitting 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 thirdparty 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.
asabaliauskas on DSK3SPTVN1PROD with NOTICES
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.
VerDate Sep<11>2014
18:40 Jul 15, 2016
Jkt 238001
• 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 https://
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 https://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
PO 00000
Frm 00056
Fmt 4703
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46695
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 https://
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
https://www.fda.gov. A link to the
transcripts will also be available
approximately 45 days after the public
workshop on the Internet at https://
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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Eye Institute; Notice of Closed
Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following meeting.
The meeting will be closed to the
public in accordance with the
E:\FR\FM\18JYN1.SGM
18JYN1
]]>Agencies
[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 https://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 https://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 https://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 https://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
https://www.fda.gov. A link to the transcripts will also be available
approximately 45 days after the public workshop on the Internet at
https://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
