2016-24438: Medical Devices; Custom Devices; Technical Amendment
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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 FDASIA, amends the existing custom device exemption and introduces new concepts and procedures applicable to custom devices. This action is being taken to align the regulations with the FD&C Act.
The agency’s own summary, as published.
What this changes
Amends 2 parts of the Code of Federal Regulations — the standing rules this notice rewrites.
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