The Accreditation Scheme for Conformity Assessment Pilot Program; Draft Guidance for Industry, Accreditation Bodies, Testing Laboratories, and Food and Drug Administration Staff; Availability, 49741-49743 [2019-20543]
Download as PDF
Federal Register / Vol. 84, No. 184 / Monday, September 23, 2019 / Notices
will publish a final notice in the Federal
Register announcing the result of our
evaluation.
IV. Collection of Information
Requirements
This document does not impose
information collection and
requirements, that is, reporting,
recordkeeping or third party disclosure
requirements. Consequently, there is no
need for review by the Office of
Management and Budget under the
authority of the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501 et seq.).
V. Response to Comments
Because of the large number of public
comments we normally receive on
Federal Register documents, we are not
able to acknowledge or respond to them
individually. We will consider all
comments we receive by the date and
time specified in the DATES section of
this preamble, and, when we proceed
with a subsequent document, we will
respond to the comments in the
preamble to that document.
Dated: September 6, 2019.
Seema Verma,
Administrator, Centers for Medicare &
Medicaid Services.
[FR Doc. 2019–20466 Filed 9–20–19; 8:45 am]
BILLING CODE 4120–01–P
You may submit comments
on any guidance at any time as follows:
Electronic Submissions
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Draft Guidance for Industry,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
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
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announcing the availability of the draft
guidance entitled ‘‘The Accreditation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),
jbell on DSK3GLQ082PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
17:55 Sep 20, 2019
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written comments on the draft guidance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.
DATES:
ADDRESSES:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
AGENCY:
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.
Jkt 247001
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’’).
PO 00000
Frm 00037
Fmt 4703
Sfmt 4703
49741
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/201523389.pdf.
Docket: For access to the docket to
read background documents or the
E:\FR\FM\23SEN1.SGM
23SEN1
49742
Federal Register / Vol. 84, No. 184 / Monday, September 23, 2019 / Notices
jbell on DSK3GLQ082PROD with NOTICES
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
VerDate Sep<11>2014
17:55 Sep 20, 2019
Jkt 247001
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. ASCAaccredited 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
1 Federal Register Notice: https://
www.federalregister.gov/documents/2018/01/16/
2018-00551/accreditation-scheme-for-conformityassessment-of-medical-devices-to-food-and-drug.
PO 00000
Frm 00038
Fmt 4703
Sfmt 4703
policies outlined in this guidance
regarding demonstration of competence
and program participation by
accreditation bodies and testing
laboratories.
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-bloodbiologics/guidance-complianceregulatory-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 CDRHGuidance@fda.hhs.gov 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
E:\FR\FM\23SEN1.SGM
23SEN1
Federal Register / Vol. 84, No. 184 / Monday, September 23, 2019 / Notices
following FDA regulations and guidance
have been approved by OMB as listed in
the following table:
OMB control
No.
21 CFR part or guidance
Topic
807, subpart E ............................................................................
814, subparts A through E ..........................................................
814, subpart H ............................................................................
812 ..............................................................................................
‘‘De Novo Classification Process (Evaluation of Automatic
Class III Designation)’’.
312 ..............................................................................................
601 ..............................................................................................
Premarket Notification ................................................................
Premarket Approval ...................................................................
Humanitarian Device Exemption ...............................................
Investigational Device Exemption ..............................................
De Novo Classification Process ................................................
0910–0120
0910–0231
0910–0332
0910–0078
0910–0844
Investigational New Drug Application ........................................
Biologics License Application ....................................................
0910–0014
0910–0338
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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2019–D–3679]
Interacting With the Food and Drug
Administration on Complex Innovative
Clinical Trial Designs for Drugs and
Biological Products; Draft Guidance
for Industry; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a draft
guidance for industry entitled
‘‘Interacting with the FDA on Complex
Innovative Clinical Trial Designs for
Drugs and Biological Products.’’ The
draft guidance document provides
recommendations to sponsors and
applicants on interacting with the FDA
on complex innovative clinical trial
design (CID) proposals for drugs or
biological products. In accordance with
the mandate under the 21st Century
Cures Act (Cures Act), the draft
guidance discusses the use of novel trial
designs in the development and
regulatory review of drugs and
biological products, how sponsors may
obtain feedback on technical issues
related to modeling and simulation, and
the types of quantitative and qualitative
information that should be submitted
for review.
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.
SUMMARY:
jbell on DSK3GLQ082PROD with NOTICES
49743
VerDate Sep<11>2014
17:55 Sep 20, 2019
Jkt 247001
You may submit comments
on any guidance at any time as follows:
ADDRESSES:
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–3679 for ‘‘Interacting with the
FDA on Complex Innovative Clinical
PO 00000
Frm 00039
Fmt 4703
Sfmt 4703
Trial Designs for Drugs and Biological
Products; Draft Guidance for Industry.’’
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/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
E:\FR\FM\23SEN1.SGM
23SEN1
Agencies
[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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