Medical Devices; Custom Devices; Technical Amendment
Information
Type
Rule
Regulated products
Medical Devices
Published
October 12, 2016
Last updated
October 12, 2016
Description
Document number 2016-24438. 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.
Tags
Organization
Country / Region
United States
License
Other (Public Domain)