Notice2024-21673
The Accreditation Scheme for Conformity Assessment Program; Draft Guidances for Industry, Accreditation Bodies, Testing Laboratories, and Food and Drug Administration Staff; Availability
Primary source
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Published
September 23, 2024
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or Agency) is announcing the availability of three draft guidance documents for the Accreditation Scheme for Conformity Assessment Program entitled "The Accreditation Scheme for Conformity Assessment (ASCA) Program; Guidance for Industry, Accreditation Bodies, Testing Laboratories, and FDA Staff;" "Basic Safety and Essential Performance of Medical Electrical Equipment, Medical Electrical Systems, and Laboratory Medical Equipment--Standards Specific Information for the Accreditation Scheme for Conformity Assessment (ASCA) Program: Guidance for Industry, Accreditation Bodies, Testing Laboratories, and FDA Staff;" and "Biocompatibility Testing of Medical Devices--Standards Specific Information for the Accreditation Scheme for Conformity Assessment (ASCA) Program: Guidance for Industry, Accreditation Bodies, Testing Laboratories, and FDA Staff." In accordance with amendments made by the FDA User Fee Reauthorization Act of 2022 (FUFRA), part of the Medical Device User Fee Amendments of 2022 (MDUFA V), FDA was directed to conclude the Pilot Accreditation Scheme for Conformity Assessment Program by the end of fiscal year 2023 and continue to operate the program (hereafter referred to as the ASCA Program) consistent with the amended FD&C Act. FDA is publishing these draft guidance documents which, when finalized, are intended to provide updates to improve the ASCA Program. These draft guidance documents are not final nor for implementation at this time.
Full Text
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<title>Federal Register, Volume 89 Issue 184 (Monday, September 23, 2024)</title>
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[Federal Register Volume 89, Number 184 (Monday, September 23, 2024)]
[Notices]
[Pages 77526-77528]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-21673]
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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 Program; Draft
Guidances 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 three draft guidance documents for the
Accreditation Scheme for Conformity Assessment Program entitled ``The
Accreditation Scheme for Conformity Assessment (ASCA) Program; Guidance
for Industry, Accreditation Bodies, Testing Laboratories, and FDA
Staff;'' ``Basic Safety and Essential Performance of Medical Electrical
Equipment, Medical Electrical Systems, and Laboratory Medical
Equipment--Standards Specific Information for the Accreditation Scheme
for Conformity Assessment (ASCA) Program: Guidance for Industry,
Accreditation Bodies, Testing Laboratories, and FDA Staff;'' and
``Biocompatibility Testing of Medical Devices--Standards Specific
Information for the Accreditation Scheme for Conformity Assessment
(ASCA) Program: Guidance for Industry, Accreditation Bodies, Testing
Laboratories, and FDA Staff.'' In accordance with amendments made by
the FDA User Fee Reauthorization Act of 2022 (FUFRA), part of the
Medical Device User Fee Amendments of 2022 (MDUFA V), FDA was directed
to conclude the Pilot Accreditation Scheme for Conformity Assessment
Program by the end of fiscal year 2023 and continue to operate the
program (hereafter referred to as the ASCA Program) consistent with the
amended FD&C Act. FDA is publishing these draft guidance documents
which, when finalized, are intended to provide updates to improve the
ASCA Program. These draft guidance documents are not final nor for
implementation at this time.
DATES: Submit either electronic or written comments on the draft
guidance by November 22, 2024 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:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<bullet> 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:
<bullet> 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.
<bullet> 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) Program; Guidance for Industry, Accreditation Bodies,
Testing Laboratories, and FDA Staff;'' ``Basic Safety and Essential
Performance of Medical Electrical Equipment, Medical Electrical
Systems, and Laboratory Medical Equipment--Standards Specific
Information for the Accreditation Scheme for Conformity Assessment
(ASCA) Program: Guidance for Industry, Accreditation Bodies, Testing
Laboratories, and FDA Staff;'' and ``Biocompatibility Testing of
Medical Devices--Standards Specific Information for the Accreditation
[[Page 77527]]
Scheme for Conformity Assessment (ASCA) Program: Guidance for Industry,
Accreditation Bodies, Testing Laboratories, and FDA Staff.'' Received
comments will be placed in the docket and, except for those submitted
as ``Confidential Submissions,'' publicly viewable at <a href="https://www.regulations.gov">https://www.regulations.gov</a> or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday, 240-402-7500.
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
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: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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, 240-402-7500.
You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
Electronic copies of these three guidance documents are available
for download from the internet. See the SUPPLEMENTARY INFORMATION
section for information on electronic access to the guidances. Submit
written requests for single hard copies of the draft guidance documents
entitled ``The Accreditation Scheme for Conformity Assessment (ASCA)
Program; Guidance for Industry, Accreditation Bodies, Testing
Laboratories, and FDA Staff''; ``Basic Safety and Essential Performance
of Medical Electrical Equipment, Medical Electrical Systems, and
Laboratory Medical Equipment--Standards Specific Information for the
Accreditation Scheme for Conformity Assessment (ASCA) Program: Guidance
for Industry, Accreditation Bodies, Testing Laboratories, and FDA
Staff''; and ``Biocompatibility Testing of Medical Devices--Standards
Specific Information for the Accreditation Scheme for Conformity
Assessment (ASCA) Program: Guidance for Industry, Accreditation Bodies,
Testing Laboratories, and FDA Staff'' to the Office of Policy, Center
for Devices and Radiological Health, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 66, Rm. 5431, Silver Spring, MD 20993-
0002. Send one self-addressed adhesive label to assist that office in
processing your request.
FOR FURTHER INFORMATION CONTACT: Eric Franca, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 5500, Silver Spring, MD 20993-0002, 301-796-4505,
<a href="/cdn-cgi/l/email-protection#7c3d2f3f3d3c1a181d5214140f521b130a"><span class="__cf_email__" data-cfemail="4e0f1d0d0f0e282a2f6026263d60292138">[email protected]</span></a>; or James Myers, Center for Biologics Evaluation and
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
71, Rm. 7301, Silver Spring, MD 20993, 240-402-7911.
SUPPLEMENTARY INFORMATION:
I. Background
FDA has concluded the ASCA pilot phase and is establishing an
ongoing ASCA Program, in accordance with amendments made to section 514
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360d) by section
2005 of the FDA User Fee Reauthorization Act of 2022, part of the
Medical Device User Fee Amendments of 2022. The three final ASCA Pilot
guidance documents issued on September 25, 2020, are also being updated
to make improvements to the ASCA Program based on lessons learned
during ASCA's pilot phase and to convey the commitments stipulated in
MDUFA V. These draft guidance updates incorporate feedback received
through public meetings and webinars, the docket, stakeholder meetings,
communications with participating accreditation bodies and testing
laboratories, and lessons learned internally from review staff and ASCA
staff during the pilot phase. The updates will also allow FDA to
appropriately expand ASCA per MDUFA V commitments and expectations.
These draft guidances are being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidances,
when finalized, will represent the current thinking of FDA on the ASCA
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.
II. 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 <a href="https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/guidance-documents-medical-devices-and-radiation-emitting-products">https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/guidance-documents-medical-devices-and-radiation-emitting-products</a>. This guidance document is also
available at <a href="https://www.regulations.gov">https://www.regulations.gov</a>, <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents">https://www.fda.gov/regulatory-information/search-fda-guidance-documents</a>, or <a href="https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics">https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics</a>. Persons unable to download an electronic copy of
``The Accreditation Scheme for Conformity Assessment (ASCA) Program;
Guidance for Industry, Accreditation Bodies, Testing Laboratories, and
FDA Staff;'' ``Basic Safety and Essential Performance of Medical
Electrical Equipment, Medical Electrical Systems, and Laboratory
Medical Equipment--Standards Specific Information for the Accreditation
Scheme for Conformity Assessment (ASCA) Program: Guidance for Industry,
Accreditation Bodies, Testing Laboratories, and FDA Staff;'' and
``Biocompatibility Testing of Medical Devices--Standards Specific
Information for the Accreditation Scheme for Conformity Assessment
(ASCA) Program: Guidance for Industry, Accreditation Bodies, Testing
Laboratories, and FDA Staff'' may send an email request to <a href="/cdn-cgi/l/email-protection#226166706a0f65574b46434c4147624446430c4a4a510c454d54"><span class="__cf_email__" data-cfemail="480b0c1a00650f3d212c29262b2d082e2c296620203b662f273e">[email protected]</span></a> to receive an electronic copy of the document.
Please use the document numbers GUI00017037, GUI00020011, and/or
GUI00020012, respectively, and complete title(s) to identify the
guidance(s) you are requesting.
III. Paperwork Reduction Act of 1995
While this guidance contains no new collection of information, it
does refer to previously approved FDA collections of
[[Page 77528]]
information. The previously approved collections of information are
subject to review by the Office of Management and Budget (OMB) under
the Paperwork Reduction act of 1995 (PRA) (44 U.S.C. 3501-3521). The
collections of information in the following table have been approved by
OMB:
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21 CFR part; guidance; or FDA OMB Control
form Topic No.
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``The Accreditation Scheme for ASCA Program.............. 0910-0889
Conformity Assessment (ASCA)
Program''.
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.
860, subpart D................ De Novo classification 0910-0844
process.
``Requests for Feedback and Q-submissions............. 0910-0756
Meetings for Medical Device
Submissions: The Q-Submission
Program''.
803........................... Medical Devices; Medical 0910-0437
Device Reporting;
Manufacturer reporting,
importer reporting, user
facility reporting,
distributor reporting.
820........................... Current Good Manufacturing 0910-0073
Practice (CGMP); Quality
System (QS) Regulation.
58............................ Good Laboratory Practice 0910-0119
(GLP) Regulations for
Nonclinical Laboratory
Studies.
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Dated: September 18, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-21673 Filed 9-20-24; 8:45 am]
BILLING CODE 4164-01-P
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