This ICR collects information from
persons who wish to be accredited by the Agency to review certain
premarket notifications. Participation in this third-party review
program by accredited persons is entirely voluntary. A third party
wishing to participate will submit a request for accreditation to
FDA. Accredited third-party reviewers have the ability to review a
manufacturer's premarket notification for selected medical devices.
After reviewing a submission, the reviewer will forward a copy of
the submission, along with the reviewer's documented review and
recommendation to FDA. Third-party reviewers also maintain records
of their reviews and a copy of the submission. The purpose of the
program is: (1) to provide manufacturers of eligible devices with
an alternative review process that could yield more rapid marketing
clearance decisions and (2) enable FDA to target its scientific
review resources at higher-risk devices while maintaining
confidence in the review by third parties of low-to-moderate risk
devices.
Based on our experience with
the program since our last request for OMB approval, we have
adjusted our burden estimate. We have increased our burden estimate
for the average burden hours required per response for initial
requests for accreditation from 24 hours to 40 hours, to more
accurately reflect the time required based on recent experience of
FDA program staff. This adjustment has resulted in an increase of
15 hours to the currently approved burden. We made no other
adjustments to our burden estimate. The guidance “510(k)
Third-Party Review Program, Guidance for Industry, Food and Drug
Administration Staff and Third Party Review Organizations” (March
2020) was superseded on November 21, 2024, when FDA issued the
final guidance “510(k) Third Party Review Program and Third Party
Emergency Use Authorization (EUA) Review; Guidance for Industry,
Food and Drug Administration Staff, and Third Party Review
Organizations” (November 2024).
On behalf of this Federal agency, I certify that
the collection of information encompassed by this request complies
with 5 CFR 1320.9 and the related provisions of 5 CFR
1320.8(b)(3).
The following is a summary of the topics, regarding
the proposed collection of information, that the certification
covers:
(i) Why the information is being collected;
(ii) Use of information;
(iii) Burden estimate;
(iv) Nature of response (voluntary, required for a
benefit, or mandatory);
(v) Nature and extent of confidentiality; and
(vi) Need to display currently valid OMB control
number;
If you are unable to certify compliance with any of
these provisions, identify the item by leaving the box unchecked
and explain the reason in the Supporting Statement.
0910-0375_Supporting Statement A_2025.docx
510(k) Third-Party Review Program