📋FDA Notice on Proposed Information Collection for 510(k) Reviews
Agency Information Collection Activities; Proposed Collection; Comment Request; 510(k) Third-Party Review Program
Summary
The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on information collection associated with the 510(k) Third-Party Review Program.
Agencies
- Health and Human Services Department
- Food and Drug Administration
Business Impact
$$ - Med
This notice relates to the requirement for businesses, specifically third-party review organizations, to comply with the FDA's information collection requests under the 510(k) program. Businesses involved in medical device submissions are affected by potential accreditation processes, including the associated compliance burden and the need to maintain records for FDA review.