fda-device · Food and Drug Administration · Rule · Published 2021-08-02 · Effective 2021-09-01 · 86 FR 41383
Document
Document number
2021-15980
Federal Register citation
86 FR 41383
CFR reference
21 CFR 201
Type
Rule
Action
Final rule.
Category
fda-device
Sub-agency
Food and Drug Administration
Publication date
2021-08-02
Effective date
2021-09-01
HHS docket
Docket No. FDA-2015-N-2002
Abstract
The Food and Drug Administration (FDA, the Agency, or we) is issuing a final rule to amend its medical product "intended use" regulations. This final rule amends FDA's regulations describing the types of evidence relevant to determining whether a product is intended for use as a drug or device under the Federal Food, Drug, and Cosmetic Act (FD&C Act), the Public Health Service Act (PHS Act), and FDA's implementing regulations, including whether a medical product that is approved, cleared, granted marketing authorization, or exempted from premarket notification is intended for a new use. This action also withdraws and replaces the portions of a final rule issued on January 9, 2017, that never became effective.