25 Sep 2025
⚗️FDA Notice
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Agreement for Shipment of Devices for Sterilization
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 and contract sterilizers in relation to an FDA information collection. It impacts how businesses label and ship devices, carrying implications for regulatory compliance, recordkeeping burdens, and potential economic activities tied to sterilization processes.