Author Topic: FDA Latest - Federal Register: Medical Devices; Custom Devices; Request for Comments  (Read 504 times)

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Federal Register: Medical Devices; Custom Devices; Request for Comments

The FDA is in the process of developing an implementation strategy and policy for the custom device exemption criteria in the FD&C Act amended by FDASIA. FDA is seeking information on appropriate uses of the custom device exemption.

Source: Federal Register: Medical Devices; Custom Devices; Request for Comments

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