Humanitarian Use Devices; 21st Century Cures Act; Technical Amendment
other · Food and Drug Administration · Rule · Published 2017-06-07 · Effective 2017-06-07 · 82 FR 26348
Document
Document number
2017-11816
Federal Register citation
82 FR 26348
CFR reference
21 CFR 814
Type
Rule
Action
Final rule; technical amendment.
Category
other
Sub-agency
Food and Drug Administration
Publication date
2017-06-07
Effective date
2017-06-07
HHS docket
Docket No. FDA-2017-N-0011
Abstract
The Food and Drug Administration (FDA) is amending regulations to reflect changes recently enacted into law by the 21st Century Cures Act. Specifically, certain requirements related to humanitarian device exemptions (HDEs) and institutional review boards (IRBs) for devices have changed. This action is being taken to align the regulations with the Federal Food, Drug, and Cosmetic Act (the FD&C Act) as amended.