[Federal Register Volume 89, Number 184 (Monday, September 23, 2024)]
[Notices]
[Pages 77526-77528]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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the availability of three draft guidance documents for the 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 FDA is publishing these draft guidance documents 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 These draft guidance documents are not final nor for 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DATES: Submit either electronic or written comments on the draft 
guidance by November 22, 2024 to ensure that the Agency considers your 
comment on this draft guidance before it begins work on the final 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: 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.
    <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 https://www.regulations.gov 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 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.govinfo.gov/content/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, 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 https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/guidance-documents-medical-devices-and-radiation-emitting-products. This guidance document is also 
available at https://www.regulations.gov, https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics. 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:

------------------------------------------------------------------------
 21 CFR part; guidance; or FDA                              OMB  Control
             form                          Topic                 No.
------------------------------------------------------------------------
``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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