Medical Devices; Medical Device Classification Regulations To Conform to Medical Software Provisions in the 21st Century Cures Act
fda-device · Food and Drug Administration · Rule · Published 2021-04-19 · Effective 2021-04-19 · 86 FR 20278
Document
Document number
2021-07860
Federal Register citation
86 FR 20278
CFR reference
21 CFR 862
Type
Rule
Action
Final rule.
Category
fda-device
Sub-agency
Food and Drug Administration
Publication date
2021-04-19
Effective date
2021-04-19
HHS docket
Docket No. FDA-2018-N-1440
Abstract
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.