Medical Devices; Custom Devices; Technical Amendment. Final rule; technical amendment.

  • Published 2016 in Federal register


The Food and Drug Administration (FDA or Agency) is amending its regulations on the definition of a custom device so as to include new enumerated statutory requirements for custom devices under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) as amended by the Food and Drug Administration Safety and Innovation Act (FDASIA). This new provision, under… (More)


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