July 08, 2025
The Food and Drug Administration is requesting public comments on two separate information collection activities that support key regulatory programs: the 510(k) Third-Party Review Program and the Clinical Laboratory Improvement Amendments of 1988 (CLIA) test categorization and waiver application processes.
FDA is proposing a revision to the estimated burden associated with its 510(k) Third-Party Review Program. The update reflects the recent program experience of FDA staff and increases the estimated time required for initial accreditation requests from 24 to 40 hours.
The proposed revision follows the release of FDA’s November 2024 final guidance, which outlines expectations for 510(k) and emergency use authorization (EUA) reviews conducted by third-party review organizations. The guidance also describes how FDA may contract with third-party organizations to review EUA requests during public health emergencies.
FDA invites comments on the necessity and practical utility of the proposed collection, the accuracy of its burden estimates and suggestions to improve data quality or reduce respondent burden. The deadline to submit feedback is Sept. 2.
FDA is also requesting public comments on the extension of its information collection activities related to CLIA test categorization and waiver application processes.
This collection supports FDA’s implementation of statutory and regulatory provisions for assigning complexity categories to laboratory tests and reviewing applications for CLIA waivers. FDA estimates a total annual burden of approximately 80,430 hours, which reflects a recent increase in submission volume.
The agency invites comments on the necessity and practical utility of the information collection, the accuracy of its burden estimates and suggestions to improve data quality or reduce respondent burden, including through the use of automated collection techniques. Comments are due by Sept. 2.
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