FDA - Proposed Regulatory Changes For SUDs

The FDA has submitted the following proposed collection of information to OMB for review and clearance: Guidance for Industry and Food and Drug Administration Staff; Compliance With Section 301 of the Medical Device User Fee and Modernization Act of 2002, as Amended: Prominent and Conspicuous Mark of Manufacturers on Single-Use Devices (formerly ``Reprocessed Single-Use Device Labeling'') (Federal Food, Drug and Cosmetic Act, Section 502(u)) (OMB Control Number 0910-0577) -- Extension. This is about requiring devices (both new and reprocessed) to bear prominently and conspicuously, the name of the manufacturer, a generally recognized abbreviation of such name, or a unique and generally recognized symbol identifying the manufacturer. 

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