federal_register: 2017-11816
Data license: Public Domain (U.S. Government data) · Data source: Federal Register API & Regulations.gov API
This data as json
| document_number | title | type | abstract | publication_date | pub_year | pub_month | html_url | pdf_url | agency_names | agency_ids | excerpts |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 2017-11816 | Humanitarian Use Devices; 21st Century Cures Act; Technical Amendment | Rule | The Food and Drug Administration (FDA) is amending regulations to reflect changes recently enacted into law by the 21st Century Cures Act. Specifically, certain requirements related to humanitarian device exemptions (HDEs) and institutional review boards (IRBs) for devices have changed. This action is being taken to align the regulations with the Federal Food, Drug, and Cosmetic Act (the FD&C Act) as amended. | 2017-06-07 | 2017 | 6 | https://www.federalregister.gov/documents/2017/06/07/2017-11816/humanitarian-use-devices-21st-century-cures-act-technical-amendment | https://www.govinfo.gov/content/pkg/FR-2017-06-07/pdf/2017-11816.pdf | Health and Human Services Department; Food and Drug Administration | 221,199 | The Food and Drug Administration (FDA) is amending regulations to reflect changes recently enacted into law by the 21st Century Cures Act. Specifically, certain requirements related to humanitarian device exemptions (HDEs) and institutional review... |