16 Jun 2025
🚨FDA Notice on Information Collection for Medical Devices Regulation
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Administrative Detention and Banned Medical Devices
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.
Agencies
- Health and Human Services Department
- Food and Drug Administration
Business Impact
$$ - Med
The regulatory document outlines compliance requirements for businesses handling medical devices, particularly regarding administrative detentions and banned devices. Business owners must be aware of recordkeeping and reporting obligations to avoid penalties.