Humanitarian Use Devices; 21st Century Cures Act; Technical Amendment
Information
Type
Rule
Regulated products
Published
June 7, 2017
Last updated
June 7, 2017
Description
Document number 2017-11816. 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.
Tags
Organization
Country / Region
United States
License
Other (Public Domain)