83 FR 2165 - Accreditation Scheme for Conformity Assessment of Medical Devices to Food and Drug Administration-Recognized Standards; Public Workshop; Request for Comments

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 83, Issue 10 (January 16, 2018)

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.

[Federal Register Volume 83, Number 10 (Tuesday, January 16, 2018)]
[Notices]
[Pages 2165-2167]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-00551]


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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.

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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.thefederalregister.org/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