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

Issuing agencies

Abstract

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.

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<title>Federal Register, Volume 91 Issue 204 (Friday, October 23, 2026)</title>
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[Federal Register Volume 91, Number 204 (Friday, October 23, 2026)]
[Notices]
[Pages 66845-66848]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-21712]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2026-N-7130]


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 November 23, 2026.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be submitted to <a href="https://www.reginfo.gov/public/do/PRAMain">https://www.reginfo.gov/public/do/PRAMain</a>. 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: Amber Barrett, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A-12M, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-8867, 
<a href="/cdn-cgi/l/email-protection#f3a3a1b2a087929595b3959792dd9b9b80dd949c85"><span class="__cf_email__" data-cfemail="9bcbc9dac8effafdfddbfdfffab5f3f3e8b5fcf4ed">[email&#160;protected]</span></a>.

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--Reinstatement

    The FDA Reauthorization Act of 2017 (FDARA), enacted as part of the 
Medical Device User Fee Amendments of 2017 (MDUFA IV), amended section 
514 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) by adding 
Section 514(d). Section 514(d) directed FDA to establish a pilot 
program under which testing laboratories may be accredited by 
accreditation bodies meeting criteria specified by FDA to assess 
whether a device conforms with certain FDA-recognized consensus 
standards. The FDA User Fee Reauthorization Act of 2022 (FUFRA), 
enacted as part of the Medical Device User Fee Amendments of 2022 
(MDUFA V), subsequently directed FDA to conclude the pilot phase and 
continue the Accreditation Scheme for Conformity Assessment (ASCA) as 
an ongoing program.
    FDA generally accepts determinations by ASCA-accredited testing 
laboratories that a device conforms with an eligible standard unless 
FDA determines that a particular conformity determination should not be 
accepted.
    The statute provides that FDA may review determinations made by 
accredited testing laboratories, including by conducting periodic 
audits of such determinations or reviewing the 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 ASCA-accredited testing laboratory, FDA may take additional measures 
as determined appropriate. Such measures may include suspension or 
withdrawal of a testing laboratory's ASCA Accreditation, withdrawal of 
an accreditation body's ASCA Recognition, or a request for additional 
information regarding a specific device.
    FDA issued the final guidance ``The Accreditation Scheme for 
Conformity Assessment (ASCA) Pilot Program'' in September 2020 to 
discuss the goals and implementation of the voluntary ASCA Pilot 
Program. In September 2024, FDA issued three draft guidance documents 
intended to update the ASCA Program based on lessons learned during the 
pilot phase and support its continued operation as an ongoing program.
    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

[[Page 66846]]

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.
    Under the ASCA Program's conformity assessment scheme, ASCA-
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 Program. When an 
ASCA-accredited testing laboratory conducts such testing, it may 
provide a complete 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 a 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 eligible for inclusion 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 request 
ASCA Recognition from FDA. Testing laboratories first obtain 
accreditation from an ASCA-recognized accreditation body and then 
request ASCA Accreditation from FDA. Each application includes an 
agreement to comply with the applicable 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 recognizes qualified applicants as 
participants. In its recognition, FDA will identify the scope of 
recognition of specific standards and test methods to which each 
participant may accredit or test as part of the ASCA Program.
    After recognizing a testing laboratory as a participant in the ASCA 
Program, FDA will generally grant the testing laboratory ASCA 
Accreditation. During the ASCA Program, FDA generally will accept 
determinations from ASCA-accredited testing laboratories that a medical 
device is in conformity with the specified testing 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. The ASCA Declaration of Conformity, including any ASCA-
specific content required therein, is submitted as part of a premarket 
submission and is therefore not covered under this ICR.
    ASCA Accreditation is separate from any accreditation that an 
accreditation body may provide to a testing laboratory for purposes 
other than the ASCA Program. FDA's decision to recognize the 
accreditation for purposes of the ASCA Program is separate and distinct 
from any independent decision by the accreditation body with respect to 
a testing laboratory for purposes outside of the ASCA Program.
    The ASCA Program does not address all specific content for a 
particular premarket submission. Specifically, the ASCA Declaration of 
Conformity and its ASCA-specific content are submitted in connection 
with a premarket submission and are subject to the information 
collection requirements applicable to premarket submissions, which have 
been previously approved. Information collections associated with 
premarket submissions are therefore not included in this ICR.
    Respondents are accreditation bodies (ABs) and testing laboratories 
(TLs). In tables 1 through 3, these abbreviations are used.
    In the Federal Register of July 17, 2026 (91 FR 44854) FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. Two comments were received. Both comments 
were determined to be PRA-related.
    The first comment was submitted by an ASCA-recognized accreditation 
body. The commentor commented on the extension process for currently 
recognized accreditation bodies under Section X, Subsection C 
(Extension of ASCA Recognition) of the ASCA Pilot Program Final 
Guidance (September 25, 2020). The commentor recommended that FDA 
streamline the process by limiting submission requirements to 
information directly relevant to the requested extension and any 
information that has materially changed since the accreditation body's 
most recent recognition or renewal, rather than requiring resubmission 
of documentation FDA has recently reviewed.
    FDA appreciates the commentor's comment and acknowledges the 
concern that the current extension process may generate duplicative 
administrative burden for accreditation bodies and FDA staff. FDA is 
currently preparing the final version of the ASCA Program Guidance 
(draft September 20, 2024) that will replace the ASCA Pilot Program 
Guidance of September 25, 2020, which we believe will address concerns 
like these. FDA will continue to evaluate opportunities to reduce 
unnecessary burden while preserving the integrity of the ASCA Program's 
oversight framework.
    The second comment was received from a patient, the commenter 
addressed two PRA-related topics: the practical utility of the 
information collected, and three (3) ways to enhance its quality, 
utility, and clarity. On practical utility, the commenter observed that 
the collection captures scopes only within the program's existing two 
standards families and therefore produces no data on where accredited 
testing would be most useful next. On quality and clarity, the 
commenter recommended adding two items to the existing feedback 
questionnaire: (1) ask respondents which FDA-recognized consensus 
standards or test methods outside the current ASCA categories they 
would use an accredited laboratory for if the program were extended; 
and (2) ask respondents whether the information generated under the 
program is available to and usable by a clinician or patient reviewing 
a device after implantation. The commenter also suggested that audit 
outcomes and the basis for withdrawal of ASCA accreditation be captured 
in the collection in a form that can be counted and compared.
    FDA appreciates the commenter's observations regarding the utility 
and quality of the ASCA Program information collection. FDA notes that 
the PRA burden estimates for the ASCA Program do not represent an 
existing or ongoing questionnaire. Rather, the estimated burden 
reflects: (a) the time

[[Page 66847]]

accreditation bodies and testing laboratories spend applying to and 
maintaining their status in the ASCA Program; and (b) the time testing 
laboratories spend completing the summary test report format for 
testing conducted under the program.
    Regarding the commenter's observations on program scope, FDA notes 
that the ASCA Program launched as a pilot, which limited the number of 
standards eligible for inclusion. The program transitioned from a pilot 
to an ongoing program in 2023, and since that time, FDA has held 
workshops and engaged regularly with program participants on the topic 
of expanding the program's scope. Expansion of the standards contained 
in the ASCA Program is an ongoing priority for FDA.
    FDA estimates the burden of this collection of information as 
follows:

                                   Table 1--Estimated Annual Reporting Burden
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                                                 Number of
          Activity               Number of     responses per   Total annual    Average burden     Total hours
                                respondents     respondent       responses      per response
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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.....               5               1               5  3..............                 15
AB notification of change...               5               1               5  1..............                  5
Application by TL for ASCA                50               1              50  4..............                200
 Accreditation.
Request by TL to continue                 75               1              75  1..............                 75
 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.....             100               1             100  1.5............                150
TL notification of change...               5               1               5  1..............                  5
Voluntary Request for                      6               1               6  0.08 (5 mins.).                  1
 withdrawal or suspension of
 ASCA Accreditation (TLs) or
 request for withdrawal of
 ASCA Recognition (ABs).
                             -----------------------------------------------------------------------------------
    Total...................  ..............  ..............  ..............  ...............                795
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                                 Table 2--Estimated Annual Recordkeeping Burden
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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 (SOPs) &                3               1               3              25              75
 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
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............             181  ..............             733
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                             Table 3--Estimated Annual Third-Party Disclosure Burden
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                                                  Number of
          Activity               Number of     disclosures per    Total annual    Average burden    Total hours
                                respondents       respondent       disclosures    per disclosure
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Request for Accreditation                150                  1             150  0.5 (30                      75
 (TLs requesting                                                                  minutes).
 accreditation from ABs).
Review/Acknowledgement of                  8                 22             176  40.............           7,040
 accreditation request (ABs).
Test Reports (TLs)..........             880                  1             880  1..............             880
                             -----------------------------------------------------------------------------------
    Total...................  ..............  .................           1,206  ...............           7,995
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[[Page 66848]]

    We have adjusted our burden estimate to reflect maturation of the 
ASCA Program, which has resulted in a decrease from the currently 
approved burden. The overall net decrease of approximately 829 burden 
hours is an adjustment, not a program change. The draft guidance 
updates issued in September 2024 contribute minimally to these 
adjustments. There are no changes to the estimated recordkeeping or 
third-party disclosure burdens.
    The decrease includes 48 hours from removing initial applications 
for ASCA Recognition; 400 hours from reducing anticipated ASCA 
Accreditation applications from 150 to 50 respondents; 225 hours from 
reducing the estimated time for TL continuation requests from 4 hours 
to 1 hour; 12 hours from reducing AB annual status reports and 
notifications of change from 8 to 5 respondents; 75 hours from reducing 
for TL annual status reports from 225 to 150 hours, and 79 hours from 
omitting feedback questionnaires conducted during the pilot.

Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2026-21712 Filed 10-22-26; 8:45 am]
BILLING CODE 4164-01-P


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