The Accreditation Scheme for Conformity Assessment Pilot Program; Draft Guidance for Industry, Accreditation Bodies, Testing Laboratories, and Food and Drug Administration Staff; Availability
| Citation | 84 FR 49741 |
| Record Number | 2019-20543 |
| Published date | 23 September 2019 |
| Section | Notices |
| Court | Food And Drug Administration |
Federal Register, Volume 84 Issue 184 (Monday, September 23, 2019)
[Federal Register Volume 84, Number 184 (Monday, September 23, 2019)]
[Notices]
[Pages 49741-49743]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-20543]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2019-D-3805]
The Accreditation Scheme for Conformity Assessment Pilot Program;
Draft Guidance for Industry, Accreditation Bodies, Testing
Laboratories, and Food and Drug Administration Staff; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of availability.
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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of the draft guidance entitled ``The Accreditation
Scheme for Conformity Assessment (ASCA) Pilot Program.'' The Pilot
Accreditation Scheme for Conformity Assessment Program (hereafter
referred to as the ASCA Pilot) is authorized under the Federal Food,
Drug, and Cosmetic Act (FD&C Act). In accordance with amendments made
to the FD&C Act by the FDA Reauthorization Act of 2017 (FDARA) and as
part of the enactment of the Medical Device User Fee Amendments of 2017
(MDUFA IV), FDA was directed to issue a draft guidance regarding the
goals and implementation of the ASCA Pilot. The establishment of the
goals, scope, procedures, and a suitable framework for the voluntary
ASCA Pilot supports the Agency's continued efforts to use its
scientific resources effectively to protect and promote public health
by simplifying certain aspects of premarket review, thereby reducing
burdens on the Agency for individual submissions. FDA believes the
voluntary ASCA Pilot may further encourage international harmonization
of medical device regulation because it incorporates elements, where
appropriate, from a well-established set of international conformity
assessment practices and standards (e.g., ISO/IEC 17000 series). The
voluntary ASCA Pilot does not supplant or alter any other existing
statutory or regulatory requirements governing the decision-making
process for premarket submissions. This draft guidance is not final nor
is it in effect at this time.
DATES: Submit either electronic or written comments on the draft
guidance by December 23, 2019 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final
version of the guidance.
ADDRESSES: You may submit comments on any guidance at any time as
follows:
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-2019-D-3805 for ``The Accreditation Scheme for Conformity
Assessment (ASCA) Pilot Program; Draft Guidance for Industry,
Accreditation Bodies, Testing Laboratories, and Food and Drug
Administration Staff.'' Received comments 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 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
[[Page 49742]]
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.
You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
An electronic copy of the guidance document is available for
download from the internet. See the SUPPLEMENTARY INFORMATION section
for information on electronic access to the guidance. Submit written
requests for a single hard copy of the draft guidance document entitled
``The Accreditation Scheme for Conformity Assessment (ASCA) Pilot
Program; Draft Guidance for Industry, Accreditation Bodies, Testing
Laboratories, and Food and Drug Administration Staff'' to the Office of
Policy, Guidance and Policy Development, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 5431, Silver Spring, MD 20993-0002 or the Office of
Communication, Outreach and Development, Center for Biologics
Evaluation and Research (CBER), Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002. Send
one self-addressed adhesive label to assist that office in processing
your request.
FOR FURTHER INFORMATION CONTACT: Erin Cutts, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 5554, Silver Spring, MD 20993-0002, 301-796-6307;
or Stephen Ripley, Center for Biologics Evaluation and Research, Food
and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301,
Silver Spring, MD 20993-0002, 240-402-7911.
SUPPLEMENTARY INFORMATION:
I. Background
The FDA Reauthorization Act of 2017 (FDARA) amended section 514 of
the FD&C Act (21 U.S.C. 360d) by adding a new subsection (d) with the
title ``Pilot Accreditation Scheme for Conformity Assessment'' (see
Pub. L. 115-52, section 205). The new section 514(d) requires FDA to
establish a pilot program under which testing laboratories may be
accredited by accreditation bodies meeting criteria specified by FDA to
assess the conformance of a device within certain FDA-recognized
standards. Determinations by testing laboratories so accredited that a
device conforms with an eligible standard included as part of the pilot
program shall be accepted by FDA for the purposes of demonstrating such
conformity unless FDA finds that a particular such determination shall
not be so accepted.
The statute provides that FDA may review determinations by
accredited testing laboratories, including by conducting periodic
audits of such determinations or processes of accreditation bodies or
testing laboratories. Following such a review, or if FDA becomes aware
of information materially bearing on safety or effectiveness of a
device assessed by an accredited testing laboratory, FDA may take
additional measures as determined appropriate, including suspension or
withdrawal of accreditation of a testing laboratory or a request for
additional information regarding a specific device.
Under the ASCA Pilot's conformity assessment scheme, recognized
accreditation bodies accredit testing laboratories using ASCA program
specifications associated with each eligible standard and ISO/IEC
17025:2017: General requirements for the competence of testing and
calibration laboratories. ASCA-accredited testing laboratories may
conduct testing to determine conformance of a device with at least one
of the standards eligible for inclusion in the ASCA Pilot. When an
ASCA-accredited testing laboratory conducts such testing, it may
provide a complete test report to the device manufacturer containing
the elements listed in the ASCA program specifications. A device
manufacturer who utilizes an ASCA-accredited testing laboratory to
perform testing in accordance with the provisions of the ASCA Pilot can
then include a declaration of conformity with supplemental
documentation (including a summary test report) as part of a premarket
submission to FDA.
FDA held a public workshop entitled ``Accreditation Scheme for
Conformity Assessment of Medical Devices to Food and Drug
Administration--Recognized Standards'' on May 22-23, 2018,\1\ to obtain
input and recommendations from stakeholders about the ASCA Pilot,
including its goals and scope as well as a suitable framework and
procedures to facilitate implementation. The ASCA Pilot is predicated
on the processes and policies outlined in this guidance regarding
demonstration of competence and program participation by accreditation
bodies and testing laboratories.
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\1\ Federal Register Notice: https://www.federalregister.gov/documents/2018/01/16/2018-00551/accreditation-scheme-for-conformity-assessment-of-medical-devices-to-food-and-drug.
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II. Significance of Guidance
This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the current thinking of FDA on the
``Accreditation Scheme for Conformity Assessment (ASCA) Pilot
Program.'' It does not establish any rights for any person and is not
binding on FDA or the public. You can use an alternative approach if it
satisfies the requirements of the applicable statutes and regulations.
This guidance is not subject to Executive Order 12866.
III. Electronic Access
Persons interested in obtaining a copy of the draft guidance may do
so by downloading an electronic copy from the internet. A search
capability for all Center for Devices and Radiological Health guidance
documents is available at https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. This
guidance document is also available at https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances or https://www.regulations.gov. Persons unable to
download an electronic copy of ``The Accreditation Scheme for
Conformity Assessment (ASCA) Pilot Program; Draft Guidance for
Industry, Accreditation Bodies, Testing Laboratories, and Food and Drug
Administration Staff'' may send an email request to [email protected] to receive an electronic copy of the document.
Please use the document number 17037 to identify the guidance you are
requesting.
IV. Paperwork Reduction Act of 1995
In the Federal Register of September 5, 2019 (84 FR 46737), FDA
requested public comment on the collections of information associated
with the ASCA Pilot. The proposed information collection and our burden
estimate is substantially the same, and is meant to encompass, the
information collections proposed in the draft guidance.
In addition, this draft guidance refers to previously approved
collections of information. These collections of information are
subject to review by the Office of Management and Budget (OMB) under
the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The
collections of information in the
[[Page 49743]]
following FDA regulations and guidance have been approved by OMB as
listed in the following table:
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OMB control
21 CFR part or guidance Topic No.
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807, subpart E................. Premarket Notification. 0910-0120
814, subparts A through E...... Premarket Approval..... 0910-0231
814, subpart H................. Humanitarian Device 0910-0332
Exemption.
812............................ Investigational Device 0910-0078
Exemption.
``De Novo Classification De Novo Classification 0910-0844
Process (Evaluation of Process.
Automatic Class III
Designation)''.
312............................ Investigational New 0910-0014
Drug Application.
601............................ Biologics License 0910-0338
Application.
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Dated: September 17, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-20543 Filed 9-20-19; 8:45 am]
BILLING CODE 4164-01-P
