3 Sep 2025
📦FDA Notice on Information Collection for Medical Device Exports
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Export of Medical Devices; Foreign Letters of Approval
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 text outlines compliance requirements for businesses exporting medical devices, specifically regarding obtaining foreign letters of approval. This process implicates regulatory obligations that businesses must meet to operate legally in international markets, impacting their operational costs and compliance strategies.