federal_register: 2021-15980
This data as json
| document_number | title | type | abstract | publication_date | pub_year | pub_month | html_url | pdf_url | agency_names | agency_ids | excerpts |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 2021-15980 | Regulations Regarding “Intended Uses” | Rule | 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. | 2021-08-02 | 2021 | 8 | https://www.federalregister.gov/documents/2021/08/02/2021-15980/regulations-regarding-intended-uses | https://www.govinfo.gov/content/pkg/FR-2021-08-02/pdf/2021-15980.pdf | Health and Human Services Department; Food and Drug Administration | 221,199 | 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... |