88 FR 124 pgs. 42076-42079 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Accreditation Scheme for Conformity Assessment Program
Type: NOTICEVolume: 88Number: 124Pages: 42076 - 42079
Pages: 42076, 42077, 42078, 42079Docket number: [Docket No. FDA-2019-N-3657]
FR document: [FR Doc. 2023-13860 Filed 6-28-23; 8:45 am]
Agency: Health and Human Services Department
Sub Agency: Food and Drug Administration
Official PDF Version: PDF Version
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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.
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, PRAStaff@fda.hhs.gov.
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
[top] 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
Footnotes:
1 ? See section 514(d)(1)(B) of the FD&C Act.
2 ? See section 514(d)(2)(A) of the FD&C Act.
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.
Footnotes:
3 ? See section 514(d)(2)(A)-(B) of the FD&C Act.
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.
Footnotes:
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.
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.
[top] 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
Footnotes:
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 ).
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:
| Activity | Number of respondents | Number of responses per respondent | Total annual responses | Average burden per response | Total hours? 2 |
|---|---|---|---|---|---|
| Application by AB for ASCA Recognition | 8 | 1 | 8 | 6 | 48 |
| Request by AB to continue ASCA Recognition | 2 | 1 | 2 | 6 | 12 |
| Request by AB for ASCA Recognition (subsequent to withdrawal) | 1 | 1 | 1 | 6 | 6 |
| Request by AB to expand scope of ASCA Recognition | 1 | 1 | 1 | 6 | 6 |
| AB annual status report | 8 | 1 | 8 | 3 | 24 |
| AB notification of change | 8 | 1 | 8 | 1 | 8 |
| Application by TL for ASCA Accreditation | 150 | 1 | 150 | 4 | 600 |
| Request by TL to continue ASCA Accreditation | 75 | 1 | 75 | 4 | 300 |
| Request by TL for ASCA Accreditation (subsequent to withdrawal or suspension) | 5 | 1 | 5 | 4 | 20 |
| Request by TL to expand scope of ASCA Accreditation | 75 | 1 | 75 | 4 | 300 |
| TL annual status report | 150 | 1 | 150 | 1.5 | 225 |
| TL notification of change | 5 | 1 | 5 | 1 | 5 |
| Request for withdrawal or suspension of ASCA Accreditation (TLs) or request for withdrawal of ASCA Recognition (ABs) | 6 | 1 | 6 | 0.08 (5 minutes) | 1 |
| Feedback questionnaire (ABs and TLs) | 158 | 1 | 158 | 0.5 (30 minutes) | 79 |
| Total | 1,634 | ||||
| 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. | |||||
| Activity | Number of recordkeepers | Number of records per recordkeeper | Total annual records | Average burden per recordkeeping | Total hours |
|---|---|---|---|---|---|
| AB setup documentation standard operating procedures (SOPs) & training (one-time burden) | 3 | 1 | 3 | 25 | 75 |
| TL setup documentation SOPs & training (one-time burden) | 20 | 1 | 20 | 25 | 500 |
| AB record maintenance | 8 | 1 | 8 | 1 | 8 |
| TL record maintenance | 150 | 1 | 150 | 1 | 150 |
| Total | 733 | ||||
| 1 ?There are no capital costs or operating and maintenance costs associated with this collection of information. | |||||
| Activity | Number of respondents | Number of disclosures per respondent | Total annual disclosures | Average burden per disclosure | Total hours |
|---|---|---|---|---|---|
| Request for Accreditation (TLs requesting accreditation from ABs) | 150 | 1 | 150 | 0.5 (30 minutes) | 75 |
| Review/Acknowledgement of accreditation request (ABs) | 8 | 22 | 176 | 40 | 7,040 |
| Test Reports (TLs) | 880 | 1 | 880 | 1 | 880 |
| Total | 7,995 | ||||
| 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.
[top] Our estimates for the number of respondents and average burden per
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]
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