29 Aug 2025
🏥FDA Notice on Electronic Submissions for Medical Device Registration
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Electronic Submissions of Medical Device Registration and Listing
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 document outlines compliance requirements for medical device manufacturers, specifically regarding electronic submissions for registration and listing to the FDA. This affects business owners and executives in the medical device industry who must comply with new reporting burdens, impacting operational and financial planning.