# Regulations Regarding “Intended Uses”
> **Food and Drug Administration** · Final rule. · Published 2021-08-02 · Effective 2021-09-01 · 86 FR 41383
## Document
- **Document number:** 2021-15980
- **Category:** fda-device
- **Sub-agency:** Food and Drug Administration
- **Federal Register citation:** 86 FR 41383
- **CFR reference:** 21 CFR 201
- **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.

## Source
- [Federal Register document](https://www.federalregister.gov/documents/2021/08/02/2021-15980/regulations-regarding-intended-uses)
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