Regulations Regarding “Intended Uses”
Information
Type
Rule
Regulated products
Published
August 2, 2021
Last updated
August 2, 2021
Description
Document number 2021-15980. 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.
Tags
Organization
Country / Region
United States
License
Other (Public Domain)