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FDA Issues Information Collection Notice on Medical Device Reporting
August 02, 2025
WASHINGTON, Aug 2 (TNSFRinfo) -- The U.S. Department of Health and Human Services Food and Drug Administration issued the following information collection:

OMB Control Number 0910-0437--Revision

This information collection supports FDA regulations, programs, forms, and guidance. Section 519 of the Federal Food Drug and Cosmetic Act (the FD&C Act) (21 U.S.C. 360i) (Records and Reports on Devices) requires user facilities, manufacturers, and importers of medical devic . . .

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