29 Jul 2025
📋FDA Medical Device Reporting Requirements and Compliance Overview
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medical Device Reporting
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
$$$ - High
The document outlines compliance and regulatory requirements regarding medical device reporting, which are crucial for manufacturers and importers of medical devices. It details the obligations to report adverse events, maintain records, and comply with special controls, impacting operational processes and costs.