[Federal Register Volume 88, Number 124 (Thursday, June 29, 2023)]
[Notices]
[Pages 42076-42079]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-13860]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-N-3657]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Accreditation Scheme 
for Conformity Assessment Program

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that a 
proposed collection of information has been submitted to the Office of 
Management and Budget (OMB) for review and clearance under the 
Paperwork Reduction Act of 1995.

DATES: Submit written comments (including recommendations) on the 
collection of information by July 31, 2023.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain. Find this particular information 
collection by selecting ``Currently under Review--Open for Public 
Comments'' or by using the search function. The OMB control number for 
this information collection is 0910-0889. Also include the FDA docket 
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A-12M, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-5733, 
[email protected].

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed collection of information to OMB for 
review and clearance.

Accreditation Scheme for Conformity Assessment Program

OMB Control Number 0910-0889--Revision

    Section 514 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) 
(21 U.S.C. 360d) provides for the establishment of performance 
standards, authorizing the Accreditation Scheme for Conformity 
Assessment Program (ASCA Program) under section 514(d). On September 
25, 2020 (85 FR 60471), we announced the

[[Page 42077]]

implementation of a pilot program under which testing laboratories may 
be accredited by ASCA-recognized accreditation bodies meeting criteria 
specified by FDA to assess the conformance of a device to certain FDA-
recognized standards. These testing laboratories then receive ASCA 
Accreditation from FDA. Determinations by ASCA-accredited testing 
laboratories that a device conforms with an eligible standard included 
as part of the program are accepted by FDA for the purposes of 
demonstrating conformity unless FDA finds that a particular such 
determination shall not be so accepted.\1\ 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.\2\
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    \1\ See section 514(d)(1)(B) of the FD&C Act.
    \2\ See section 514(d)(2)(A) of the FD&C Act.
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    Following such a review, or if FDA becomes aware of information 
materially bearing on safety or effectiveness of a device tested by an 
ASCA-accredited testing laboratory, FDA may take additional measures as 
determined appropriate, including suspension or withdrawal of ASCA 
Accreditation of a testing laboratory, withdrawal of ASCA Recognition 
of an accreditation body, or a request for additional information 
regarding a specific device.\3\ The establishment of the goals, scope, 
procedures, and a suitable framework for the voluntary ASCA Program 
supports the Agency's continued efforts to use its scientific resources 
effectively and efficiently to protect and promote public health. FDA 
believes the voluntary ASCA Program 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 Program does not supplant or 
alter any other existing statutory or regulatory requirements governing 
the decision-making process for premarket submissions.
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    \3\ See section 514(d)(2)(A)-(B) of the FD&C Act.
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    We are revising the information collection to reflect recent 
legislative changes. In accordance with amendments made to section 514 
by the FDA Reauthorization Act of 2022 (FDARA),\4\ and as part of the 
enactment of the Medical Device User Fee Amendments of 2022 (MDUFA 
V),\5\ the ``pilot'' language and sunset clause was removed from the 
section, allowing FDA to conclude the pilot and continue to operate the 
program consistent with the amended section 514(d) of the FD&C Act. In 
accordance with these updates and as included in the Center for Devices 
and Radiological Health Proposed Guidances for Fiscal Year 2023,\6\ we 
intend to update the applicable guidance documents.
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    \4\ See Public Law 117-180, section 2005.
    \5\ See also MDUFA V Commitment Letter: https://www.fda.gov/media/158308/download.
    \6\ See CDRH Proposed Guidances for Fiscal Year 2023, B-list: 
https://www.fda.gov/medical-devices/guidance-documents-medical-devices-and-radiation-emitting-products/cdrh-proposed-guidances-fiscal-year-2023-fy2023#b.
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    Finally, to assist testing laboratories and accreditation bodies in 
submitting information to FDA, we are developing webforms for applying 
for ASCA Accreditation and ASCA Recognition, respectively.
    Under the ASCA Program's conformity assessment scheme, ASCA-
recognized accreditation bodies accredit testing laboratories using 
ISO/IEC 17025:2017: ``General requirements for the competence of 
testing and calibration laboratories'' and the ASCA program 
specifications associated with each eligible standard and test method 
included in the ASCA Program. 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 Program. When an 
ASCA-accredited testing laboratory conducts such testing, it provides a 
complete test report and an ASCA Summary Test Report to the device 
manufacturer. A device manufacturer who utilizes an ASCA-accredited 
testing laboratory to perform testing in accordance with the provisions 
of the ASCA Program can then include a declaration of conformity with 
supplemental documentation (including an ASCA Summary Test Report) as 
part of a premarket submission to FDA. Testing performed by an ASCA-
accredited testing laboratory can be used to support a premarket 
submission for any device if the testing was conducted using a standard 
included in the ASCA Program and in accordance with the ASCA program 
specifications for that standard.
    The ASCA Program includes participation from accreditation bodies, 
testing laboratories, device manufacturers, and FDA staff. Each of 
these entities plays a critical role in the ASCA Program to ensure that 
patients and healthcare providers have timely and continued access to 
safe, effective, and high-quality medical devices.
    To participate in the ASCA Program, accreditation bodies and 
testing laboratories apply to FDA to demonstrate that they have the 
qualifications for their respective roles within the program. An 
application includes agreement to terms of participation. For example, 
a participating accreditation body or testing laboratory agrees to 
attend training, regularly communicate with FDA, and support periodic 
FDA audits. FDA will identify the scope of ASCA Recognition (for 
accreditation bodies) and ASCA Accreditation (for testing laboratories) 
for specific standards and test methods to which each participant may 
accredit or test as part of the ASCA Program.
    During the ASCA Program, FDA generally will accept test results 
from ASCA-accredited testing laboratories to support conformity of a 
medical device to a particular standard and does not intend to review 
complete test reports from ASCA-accredited testing laboratories in 
support of a declaration of conformity submitted with a premarket 
submission except in certain circumstances.
    Note that ASCA Accreditation is separate from any accreditation 
that an accreditation body may provide to a testing laboratory for 
purposes other than the ASCA Program.
    The ASCA Program does not address specific content for a particular 
premarket submission. Information collections associated with premarket 
submissions have been previously approved.
    We plan to issue draft guidance updates to the three published ASCA 
Pilot guidance documents \7\ to improve and streamline the ASCA 
Program. The guidance updates are being issued to discuss the lessons 
learned during ASCA's pilot phase and to help

[[Page 42078]]

facilitate the transition from a pilot to a permanent program. As a 
result of these guidance updates, there is minimal adjustment to the 
burden estimate.
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    \7\ The Accreditation Scheme for Conformity Assessment (ASCA) 
Pilot Program (https://www.fda.gov/regulatory-information/search-fda-guidance-documents/accreditation-scheme-conformity-assessment-asca-pilot-program). 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) Pilot Program 
(https://www.fda.gov/regulatory-information/search-fda-guidance-documents/basic-safety-and-essential-performance-medical-electrical-equipment-medical-electrical-systems-and). Biocompatibility Testing 
of Medical Devices--Standards Specific Information for the 
Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program 
(https://www.fda.gov/regulatory-information/search-fda-guidance-documents/biocompatibility-testing-medical-devices-standards-specific-information-accreditation-scheme).
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    Respondents are accreditation bodies (ABs) and testing laboratories 
(TLs). In tables 1 through 3, these abbreviations are used.
    In the Federal Register of January 19, 2023 (88 FR 3419), we 
published a 60-day notice requesting public comment on the proposed 
collection of information. No comments were received.
    We estimate the burden of the information collection as follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
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                                                 Number of
          Activity               Number of     responses per   Total annual   Average burden per    Total hours
                                respondents     respondent       responses         response             \2\
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Application by AB for ASCA                 8               1               8  6.................              48
 Recognition.
Request by AB to continue                  2               1               2  6.................              12
 ASCA Recognition.
Request by AB for ASCA                     1               1               1  6.................               6
 Recognition (subsequent to
 withdrawal).
Request by AB to expand                    1               1               1  6.................               6
 scope of ASCA Recognition.
AB annual status report.....               8               1               8  3.................              24
AB notification of change...               8               1               8  1.................               8
Application by TL for ASCA               150               1             150  4.................             600
 Accreditation.
Request by TL to continue                 75               1              75  4.................             300
 ASCA Accreditation.
Request by TL for ASCA                     5               1               5  4.................              20
 Accreditation (subsequent
 to withdrawal or
 suspension).
Request by TL to expand                   75               1              75  4.................             300
 scope of ASCA Accreditation.
TL annual status report.....             150               1             150  1.5...............             225
TL notification of change...               5               1               5  1.................               5
Request for withdrawal or                  6               1               6  0.08 (5 minutes)..               1
 suspension of ASCA
 Accreditation (TLs) or
 request for withdrawal of
 ASCA Recognition (ABs).
Feedback questionnaire (ABs              158               1             158  0.5 (30 minutes)..              79
 and TLs).
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    Total...................  ..............  ..............  ..............  ..................           1,634
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\1\ Totals have been rounded to the nearest hour.
\2\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.


                               Table 2--Estimated Annual Recordkeeping Burden \1\
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                                                     Number of                    Average burden
            Activity                 Number of      records per    Total annual         per         Total hours
                                   recordkeepers   recordkeeper       records      recordkeeping
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AB setup documentation standard                3               1               3              25              75
 operating procedures (SOPs) &
 training (one-time burden).....
TL setup documentation SOPs &                 20               1              20              25             500
 training (one-time burden).....
AB record maintenance...........               8               1               8               1               8
TL record maintenance...........             150               1             150               1             150
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    Total.......................  ..............  ..............  ..............  ..............             733
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.


                           Table 3--Estimated Annual Third-Party Disclosure Burden \1\
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                                                 Number of
                                 Number of      disclosures    Total annual   Average burden per
          Activity              respondents         per         disclosures       disclosure        Total hours
                                                respondent
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Request for Accreditation                150               1             150  0.5 (30 minutes)..              75
 (TLs requesting
 accreditation from ABs).
Review/Acknowledgement of                  8              22             176  40................           7,040
 accreditation request (ABs).
Test Reports (TLs)..........             880               1             880  1.................             880
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    Total...................  ..............  ..............  ..............  ..................           7,995
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    Our estimate of eight ABs is based on the number of International 
Laboratory Accreditation Cooperation signatories in the U.S. economy. 
We estimate that approximately 150 testing labs will seek ASCA 
Accreditation. Our estimate of Test Reports is based on the number of 
premarket submissions we expect per year with testing from an ASCA-
accredited testing laboratory.
    Our estimates for the number of respondents and average burden per

[[Page 42079]]

response, recordkeeping, and disclosure are based on our experience 
with the pilot program.
    Our estimated burden for the information collection reflects an 
overall decrease of 3,129 hours and an increase of 94 responses/
records. We attribute this adjustment to a decrease in the one-time 
burden for accreditation bodies and testing laboratories training and 
SOPs because much of this activity was completed during the pilot. In 
addition, there is an increase in the annual responses/records because 
there is an increase in renewal requests (by accreditation bodies to 
continue ASCA Recognition and by testing laboratories to continue ASCA 
Accreditation) since the pilot program was initiated.

    Dated: June 26, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-13860 Filed 6-28-23; 8:45 am]
BILLING CODE 4164-01-P