Accreditation Scheme for Conformity Assessment of Medical Devices to Food and Drug Administration-Recognized Standards; Public Workshop; Request for Comments, 2165-2167 [2018-00551]
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Federal Register / Vol. 83, No. 10 / Tuesday, January 16, 2018 / Notices
2165
TABLE 3—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1—Continued
Number of
respondents
Activity/21 CFR section
Total ..............................................................................
1 There
Dated: January 9, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–00568 Filed 1–12–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2017–N–6877]
Accreditation Scheme for Conformity
Assessment of Medical Devices to
Food and Drug AdministrationRecognized Standards; Public
Workshop; Request for Comments
Food and Drug Administration,
HHS.
Notice of public workshop;
request for comments.
ACTION:
The Food and Drug
Administration (FDA, the Agency, or
we) is announcing the following public
workshop entitled ‘‘Accreditation
Scheme for Conformity Assessment of
Medical Devices to FDA-Recognized
Standards.’’ The purpose of the
workshop is to present a draft design of
the Accreditation Scheme for
Conformity Assessment (ASCA) pilot
program. The workshop is intended to
discuss and obtain input and
recommendations from stakeholders on
the draft accreditation scheme,
including its goals and scope, a suitable
framework and procedures, and
requirements to facilitate
implementation of an eventual pilot
program. The overarching objectives of
the ASCA pilot program are to
streamline the standards conformity
SUMMARY:
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Total annual
disclosures
Average
burden per
disclosure
........................
........................
........................
........................
Total hours
23,100
are no capital costs or operating and maintenance costs associated with this collection of information.
The burden estimate for this
information collection has not changed
since the last OMB approval.
This document also refers to
previously approved collections of
information found in FDA regulations.
These collections of information are
subject to review by OMB under the
PRA (44 U.S.C. 3501–3520). The
collections of information found in
§§ 821.2(b), 821.25(e), and 821.30(e)
have been approved under OMB control
number 0910–0191.
AGENCY:
Number of
disclosures
per
respondent
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assessment of medical devices and to
improve consistency and predictability
in the premarket review process where
certain FDA recognized standards are
used.
DATES: The public workshop will be
held on May 22 and 23, 2018, from 9
a.m. to 5 p.m. Submit either electronic
or written comments on this public
workshop by June 29, 2018. See the
SUPPLEMENTARY INFORMATION section for
registration date and information.
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.
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.
You may submit comments as
follows. Please note that late, untimely
filed comments will not be considered.
Electronic comments must be submitted
on or before June 29, 2018. The https://
www.regulations.gov electronic filing
system will accept comments until
midnight Eastern Time at the end of
June 29, 2018. Comments received by
mail/hand delivery/courier (for written/
paper submissions) will be considered
timely if they are postmarked or the
delivery service acceptance receipt is on
or before that date.
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
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
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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 https://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): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, 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–
2017–N–6877 for ‘‘Accreditation
Scheme for Conformity Assessment of
Medical Devices to FDA-Recognized
Standards; Public Workshop; Request
for Comments.’’ Received comments,
those filed in a timely manner (see
ADDRESSES), will be placed in the docket
and, except for those submitted as
‘‘Confidential Submissions,’’ publicly
viewable at https://www.regulations.gov
or at the Dockets Management Staff
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
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Federal Register / Vol. 83, No. 10 / Tuesday, January 16, 2018 / Notices
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
https://www.regulations.gov. Submit
both copies to the Dockets Management
Staff. 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: https://www.gpo.gov/
fdsys/pkg/FR-2015-09-18/pdf/201523389.pdf.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
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 Dockets Management
Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Scott Colburn, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 5514, Silver Spring,
MD 20993–0002, 301–796–6287,
CDRHStandardsStaff@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
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I. Background
As part of the Medical Device User
Fee Amendments of 2017 (MDUFA IV),
FDA and industry agreed to establish a
Pilot Accreditation Scheme for
Conformity Assessment (ASCA)
Program for recognizing accredited
testing laboratories that evaluate
medical devices per certain FDArecognized standards. Section 514 of the
Federal Food, Drug, and Cosmetic Act
(FD&C Act) (21 U.S.C. 360d) was
amended by adding a new subsection
(d) with the title ‘‘Pilot Accreditation
Scheme for Conformity Assessment,’’
under the FDA Reauthorization Act of
2017 (FDARA). The new section 514(d)
authorizes FDA to establish a pilot
program under which FDA may select
accreditation bodies that can accredit
testing laboratories meeting FDAspecified criteria to assess conformance
of medical devices to certain FDArecognized consensus standards under
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the ASCA pilot program. The goal of
this pilot program is to streamline the
standards conformity assessment of
medical devices during the premarket
review process. The objectives of the
ASCA pilot include improved
consistency and predictability in the
premarket review process where certain
FDA recognized standards are used.
Traditionally, under section 514(c) of
the FD&C Act, FDA has been accepting
a manufacturer’s self-declaration of
conformity to an FDA-recognized
consensus standard as part of its
premarket submission. Since medical
devices are increasingly complex and
involve high risks to the patients, such
self-declaration of conformity is not
always sufficient to guarantee safety and
performance, especially when
deviations from the standard have been
introduced. In addition, testing
performed by the independent
laboratories or the manufacturers
themselves to support the selfdeclaration of conformity varies
depending on the standard being used.
As a result, reviewers sometimes need
to request and review test reports to
ensure requirements of the standard
have been met. The ASCA pilot program
is designed to address such issues
through improved quality and increased
confidence in the testing labs to achieve
a least burdensome and streamlined
regulatory process.
The purpose of this public workshop
is to present a draft design of the ASCA
scheme. FDA intends to discuss and
obtain input and recommendations from
stakeholders on the draft scheme,
including its goals and scope, its
framework and procedures, and
requirements as required per FDARA.
Public input and feedback gained
through this workshop are also intended
to aid in the development of a draft
ASCA guidance, which is another
MDUFA IV commitment.
II. Topics for Discussion at the Public
Workshop
This public workshop will consist of
both plenary presentations and breakout
sessions. A keynote presentation is
planned to provide high-level
background information about standards
use and standards conformity
assessment (CA) in medical device
regulatory processes, major existing CA
programs, and significance of and
challenges to national and international
harmonization in CA. FDA will present
background information about the
proposed ASCA pilot program, its
objectives and plans, what issues it aims
to resolve and how. Following the
plenary presentations, multiple
breakout sessions will be convened.
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Each breakout session is designed to
focus on a major ASCA-related topic.
The topics to be discussed include:
• Performance metrics to measure the
success and impact of the ASCA
• Additional requirements for
accrediting bodies beyond the
standard (ISO/IEC 17011:2017
Conformity assessment—
Requirements for accreditation bodies
accrediting conformity assessment
bodies, available at https://
www.iso.org/standard/67198.html)
and for testing organizations beyond
the standard (ISO/IEC 17025:2017
General requirements for the
competence of testing and calibration
laboratories, available at https://
www.iso.org/standard/66912.html)
• Criteria for selection of pilot
standards for ASCA
• Roles that testing organizations can
play for ASCA
A detailed agenda will be posted on
the following website in advance of the
workshop: https://www.fda.gov/
MedicalDevices/NewsEvents/
WorkshopsConferences/default.htm;
select this event from the list of items
provided. The overarching objectives of
the ASCA pilot program are to
streamline the standards conformity
assessment of medical devices, and
improve consistency and predictability
in the premarket review process where
certain FDA recognized standards are
used.
III. Participating in the Public
Workshop
Registration: To register for the public
workshop, please visit FDA’s Medical
Devices News & Events—Workshops &
Conferences calendar (https://
www.fda.gov/MedicalDevices/
NewsEvents/WorkshopsConferences/
default.htm) and select this event from
the list of items provided. Please
provide complete contact information
for each attendee, including name, title,
affiliation, address, email, and
telephone number.
Registration is free and based on
space availability, with priority given to
early registrants. Persons interested in
attending this public workshop must
register by May 14, 2018, 4 p.m. Eastern
Time. Early registration is
recommended because seating is
limited; therefore, FDA may limit the
number of participants from each
organization. Registrants will receive
confirmation when they have been
accepted. If time and space permit,
onsite registration on the day of the
public workshop will be provided
beginning at 8 a.m. We will let
registrants know if registration closes
before the day of the public workshop.
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Federal Register / Vol. 83, No. 10 / Tuesday, January 16, 2018 / Notices
If you need special accommodations
due to a disability, please contact Susan
Monahan, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 32, Rm. 5231, Silver Spring,
MD 20993–0002, 301–796–5661, or
email: Susan.Monahan@fda.hhs.gov, no
later than May 8, 2018.
Requests for Oral Presentations:
During online registration you may
indicate if you wish to present during a
public comment session or participate
in a specific session, and which topic(s)
you wish to address. We will do our
best to accommodate requests to make
public comments. 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, we 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
May 16, 2018, midnight Eastern Time.
All requests to make oral presentations
must be received by the close of
registration on May 14, 2018, 4 p.m.
Eastern Time. If selected for
presentation, any presentation materials
must be emailed to Scott Colburn (see
FOR FURTHER INFORMATION CONTACT) no
later than May 18, 2018, midnight
Eastern Time. No commercial or
promotional material will be permitted
to be presented or distributed at the
public workshop.
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 May 14, 2018. Please visit FDA’s
Medical Devices News & Events—
Workshops & Conferences calendar
(https://www.fda.gov/MedicalDevices/
NewsEvents/WorkshopsConferences/
default.htm) and select this event from
the list of items provided. Organizations
are requested to register all participants,
but to view using one connection per
location.
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 website addresses in this
document, as of the date this document
publishes in the Federal Register, but
websites are subject to change over time.
Transcripts: Please be advised that as
soon as a transcript of the public
workshop is available, it will be
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accessible at https://
www.regulations.gov. It may be viewed
at the Dockets Management Staff (see
ADDRESSES). A link to the transcript will
also be available on the internet at
https://www.fda.gov/MedicalDevices/
NewsEvents/WorkshopsConferences/
default.htm.
Dated: January 9, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–00551 Filed 1–12–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Advisory Council on Alzheimer’s
Research, Care, and Services; Meeting
Assistant Secretary for
Planning and Evaluation, HHS.
ACTION: Notice of meeting.
AGENCY:
This notice announces the
public meeting of the Advisory Council
on Alzheimer’s Research, Care, and
Services (Advisory Council). The
Advisory Council on Alzheimer’s
Research, Care, and Services provides
advice on how to prevent or reduce the
burden of Alzheimer’s disease and
related dementias on people with the
disease and their caregivers. During the
January meeting, the Research
Subcommittee will be taking charge of
the theme, focusing on the process from
targets to treatments. The Council will
hear speakers on the preclinical
pipeline, the clinical trial pipeline, and
the industry perspective. The meeting
will also include discussion of a driver
diagram to guide the Council’s future
work, updates and a report from the
October Care Summit, and federal
workgroup updates.
DATES: The meeting will be held on
January 26, 2018 from 9:00 a.m. to 5:00
p.m. EDT.
ADDRESSES: The meeting will be held in
Room 800 in the Hubert H. Humphrey
Building, 200 Independence Avenue
SW, Washington, DC 20201.
Comments: Time is allocated in the
afternoon on the agenda to hear public
comments. The time for oral comments
will be limited to two (2) minutes per
individual. In lieu of oral comments,
formal written comments may be
submitted for the record to Rohini
Khillan, OASPE, 200 Independence
Avenue SW, Room 424E, Washington,
DC 20201. Comments may also be sent
to napa@hhs.gov. Those submitting
written comments should identify
themselves and any relevant
organizational affiliations.
SUMMARY:
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FOR FURTHER INFORMATION CONTACT:
Rohini Khillan (202) 690–5932,
rohini.khillan@hhs.gov. Note: Seating
may be limited. Those wishing to attend
the meeting must send an email to
napa@hhs.gov and put ‘‘January 26
Meeting Attendance’’ in the Subject line
by Tuesday, January 16, so that their
names may be put on a list of expected
attendees and forwarded to the security
officers at the Department of Health and
Human Services. Any interested
member of the public who is a non-U.S.
citizen should include this information
at the time of registration to ensure that
the appropriate security procedure to
gain entry to the building is carried out.
Although the meeting is open to the
public, procedures governing security
and the entrance to Federal buildings
may change without notice. If you wish
to make a public comment, you must
note that within your email.
Notice of
these meetings is given under the
Federal Advisory Committee Act (5
U.S.C. App. 2, section 10(a)(1) and
(a)(2)). Topics of the Meeting: During
the January meeting, the Research
Subcommittee will be taking charge of
the theme, focusing on the process from
targets to treatments. The Council will
hear speakers on the preclinical
pipeline, the clinical trial pipeline, and
the industry perspective. The meeting
will also include discussion of a driver
diagram to guide the Council’s future
work, updates and a report from the
October Care Summit, and federal
workgroup updates.
Procedure and Agenda: This meeting
is open to the public. Please allow 30
minutes to go through security and walk
to the meeting room. The meeting will
also be webcast at www.hhs.gov/live.
SUPPLEMENTARY INFORMATION:
Authority: 42 U.S.C. 11225; Section 2(e)(3)
of the National Alzheimer’s Project Act. The
panel is governed by provisions of Public
Law 92–463, as amended (5 U.S.C. Appendix
2), which sets forth standards for the
formation and use of advisory committees.
Dated: January 9, 2018.
John R. Graham,
Acting Assistant Secretary for Planning and
Evaluation.
[FR Doc. 2018–00480 Filed 1–12–18; 8:45 am]
BILLING CODE 4150–05–P
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]]>Agencies
[Federal Register Volume 83, Number 10 (Tuesday, January 16, 2018)]
[Notices]
[Pages 2165-2167]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-00551]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2017-N-6877]
Accreditation Scheme for Conformity Assessment of Medical Devices
to Food and Drug Administration-Recognized Standards; Public Workshop;
Request for Comments
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public workshop; request for comments.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is
announcing the following public workshop entitled ``Accreditation
Scheme for Conformity Assessment of Medical Devices to FDA-Recognized
Standards.'' The purpose of the workshop is to present a draft design
of the Accreditation Scheme for Conformity Assessment (ASCA) pilot
program. The workshop is intended to discuss and obtain input and
recommendations from stakeholders on the draft accreditation scheme,
including its goals and scope, a suitable framework and procedures, and
requirements to facilitate implementation of an eventual pilot program.
The overarching objectives of the ASCA pilot program are to streamline
the standards conformity assessment of medical devices and to improve
consistency and predictability in the premarket review process where
certain FDA recognized standards are used.
DATES: The public workshop will be held on May 22 and 23, 2018, from 9
a.m. to 5 p.m. Submit either electronic or written comments on this
public workshop by June 29, 2018. See the SUPPLEMENTARY INFORMATION
section for registration date and information.
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. 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.
You may submit comments as follows. Please note that late, untimely
filed comments will not be considered. Electronic comments must be
submitted on or before June 29, 2018. The https://www.regulations.gov
electronic filing system will accept comments until midnight Eastern
Time at the end of June 29, 2018. Comments received by mail/hand
delivery/courier (for written/paper submissions) will be considered
timely if they are postmarked or the delivery service acceptance
receipt is on or before that date.
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://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 https://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): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Dockets
Management Staff, 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-2017-N-6877 for ``Accreditation Scheme for Conformity Assessment of
Medical Devices to FDA-Recognized Standards; Public Workshop; Request
for Comments.'' Received comments, those filed in a timely manner (see
ADDRESSES), will be placed in the docket and, except for those
submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff 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
[[Page 2166]]
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 https://www.regulations.gov. Submit both copies to the Dockets
Management Staff. 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: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://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 Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Scott Colburn, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 5514, Silver Spring, MD 20993-0002, 301-796-6287,
[email protected].
SUPPLEMENTARY INFORMATION:
I. Background
As part of the Medical Device User Fee Amendments of 2017 (MDUFA
IV), FDA and industry agreed to establish a Pilot Accreditation Scheme
for Conformity Assessment (ASCA) Program for recognizing accredited
testing laboratories that evaluate medical devices per certain FDA-
recognized standards. Section 514 of the Federal Food, Drug, and
Cosmetic Act (FD&C Act) (21 U.S.C. 360d) was amended by adding a new
subsection (d) with the title ``Pilot Accreditation Scheme for
Conformity Assessment,'' under the FDA Reauthorization Act of 2017
(FDARA). The new section 514(d) authorizes FDA to establish a pilot
program under which FDA may select accreditation bodies that can
accredit testing laboratories meeting FDA-specified criteria to assess
conformance of medical devices to certain FDA-recognized consensus
standards under the ASCA pilot program. The goal of this pilot program
is to streamline the standards conformity assessment of medical devices
during the premarket review process. The objectives of the ASCA pilot
include improved consistency and predictability in the premarket review
process where certain FDA recognized standards are used.
Traditionally, under section 514(c) of the FD&C Act, FDA has been
accepting a manufacturer's self-declaration of conformity to an FDA-
recognized consensus standard as part of its premarket submission.
Since medical devices are increasingly complex and involve high risks
to the patients, such self-declaration of conformity is not always
sufficient to guarantee safety and performance, especially when
deviations from the standard have been introduced. In addition, testing
performed by the independent laboratories or the manufacturers
themselves to support the self-declaration of conformity varies
depending on the standard being used. As a result, reviewers sometimes
need to request and review test reports to ensure requirements of the
standard have been met. The ASCA pilot program is designed to address
such issues through improved quality and increased confidence in the
testing labs to achieve a least burdensome and streamlined regulatory
process.
The purpose of this public workshop is to present a draft design of
the ASCA scheme. FDA intends to discuss and obtain input and
recommendations from stakeholders on the draft scheme, including its
goals and scope, its framework and procedures, and requirements as
required per FDARA. Public input and feedback gained through this
workshop are also intended to aid in the development of a draft ASCA
guidance, which is another MDUFA IV commitment.
II. Topics for Discussion at the Public Workshop
This public workshop will consist of both plenary presentations and
breakout sessions. A keynote presentation is planned to provide high-
level background information about standards use and standards
conformity assessment (CA) in medical device regulatory processes,
major existing CA programs, and significance of and challenges to
national and international harmonization in CA. FDA will present
background information about the proposed ASCA pilot program, its
objectives and plans, what issues it aims to resolve and how. Following
the plenary presentations, multiple breakout sessions will be convened.
Each breakout session is designed to focus on a major ASCA-related
topic. The topics to be discussed include:
Performance metrics to measure the success and impact of the
ASCA
Additional requirements for accrediting bodies beyond the
standard (ISO/IEC 17011:2017 Conformity assessment--Requirements for
accreditation bodies accrediting conformity assessment bodies,
available at https://www.iso.org/standard/67198.html) and for testing
organizations beyond the standard (ISO/IEC 17025:2017 General
requirements for the competence of testing and calibration
laboratories, available at https://www.iso.org/standard/66912.html)
Criteria for selection of pilot standards for ASCA
Roles that testing organizations can play for ASCA
A detailed agenda will be posted on the following website in
advance of the workshop: https://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/default.htm; select this event from the list of
items provided. The overarching objectives of the ASCA pilot program
are to streamline the standards conformity assessment of medical
devices, and improve consistency and predictability in the premarket
review process where certain FDA recognized standards are used.
III. Participating in the Public Workshop
Registration: To register for the public workshop, please visit
FDA's Medical Devices News & Events--Workshops & Conferences calendar
(https://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/default.htm) and select this event from the list of items provided.
Please provide complete contact information for each attendee,
including name, title, affiliation, address, email, and telephone
number.
Registration is free and based on space availability, with priority
given to early registrants. Persons interested in attending this public
workshop must register by May 14, 2018, 4 p.m. Eastern Time. Early
registration is recommended because seating is limited; therefore, FDA
may limit the number of participants from each organization.
Registrants will receive confirmation when they have been accepted. If
time and space permit, onsite registration on the day of the public
workshop will be provided beginning at 8 a.m. We will let registrants
know if registration closes before the day of the public workshop.
[[Page 2167]]
If you need special accommodations due to a disability, please
contact Susan Monahan, Center for Devices and Radiological Health, Food
and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 5231,
Silver Spring, MD 20993-0002, 301-796-5661, or email:
[email protected], no later than May 8, 2018.
Requests for Oral Presentations: During online registration you may
indicate if you wish to present during a public comment session or
participate in a specific session, and which topic(s) you wish to
address. We will do our best to accommodate requests to make public
comments. 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, we 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 May 16, 2018, midnight
Eastern Time. All requests to make oral presentations must be received
by the close of registration on May 14, 2018, 4 p.m. Eastern Time. If
selected for presentation, any presentation materials must be emailed
to Scott Colburn (see FOR FURTHER INFORMATION CONTACT) no later than
May 18, 2018, midnight Eastern Time. No commercial or promotional
material will be permitted to be presented or distributed at the public
workshop.
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 May 14, 2018. Please visit FDA's Medical Devices News &
Events--Workshops & Conferences calendar (https://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/default.htm) and select
this event from the list of items provided. Organizations are requested
to register all participants, but to view using one connection per
location.
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 website addresses in this document, as of the date this document
publishes in the Federal Register, but websites are subject to change
over time.
Transcripts: Please be advised that as soon as a transcript of the
public workshop is available, it will be accessible at https://www.regulations.gov. It may be viewed at the Dockets Management Staff
(see ADDRESSES). A link to the transcript will also be available on the
internet at https://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/default.htm.
Dated: January 9, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-00551 Filed 1-12-18; 8:45 am]
BILLING CODE 4164-01-P
