Medical Devices; Custom Devices; Technical Amendment
fda-device · Food and Drug Administration · Rule · Published 2016-10-12 · Effective 2016-10-12 · 81 FR 70339
Document
Document number
2016-24438
Federal Register citation
81 FR 70339
CFR reference
21 CFR 807
Type
Rule
Action
Final rule; technical amendment.
Category
fda-device
Sub-agency
Food and Drug Administration
Publication date
2016-10-12
Effective date
2016-10-12
HHS docket
Docket No. FDA-2016-N-2518
Abstract
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.