Medical Devices; Medical Device Classification Regulations To Conform to Medical Software Provisions in the 21st Century Cures Act
Information
Type
Rule
Regulated products
Medical Devices
Published
April 19, 2021
Last updated
April 19, 2021
Description
Document number 2021-07860. The Food and Drug Administration (FDA, Agency, or we) is amending certain classification regulations to reflect changes to the Federal Food, Drug, and Cosmetic Act (FD&C Act) made by the 21st Century Cures Act (the Cures Act). The Cures Act amended the definition of a device in the FD&C Act to exclude certain software functions. FDA is taking this action so that its regulations conform to the medical software provisions in the Cures Act.
Tags
Organization
Country / Region
United States
License
Other (Public Domain)