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Guidance on User Fees for FDA Device Classification Info

04/06/2012

Federal Register Notice: FDA is making available, Guidance for Industry and Food and Drug Administration Staff; User Fees for 513(g) Requests for Information. This guidance document describes the user fees for 513(g) requests, which provide a means for obtaining FDA’s views about classification information and the regulatory requirements that may be applicable to a particular device. To download this guidance, click here. To view this notice, click here.

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