federal_register: 2024-27085
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 | regulation_id_numbers |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2024-27085 | 510(k) Third Party Review Program and Third Party Emergency Use Authorization Review; Guidance for Industry, Food and Drug Administration Staff, and Third Party Review Organizations; Availability | Notice | The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled "510(k) Third Party Review Program and Third Party Emergency Use Authorization (EUA) Review." This guidance provides FDA's current thinking regarding the 510(k) Third Party (3P510k) Review Program and review of EUA requests by a third party review organization (3PEUA review). The 3P510k Review Program and 3PEUA review create an alternative process for manufacturers to seek review of 510(k) submissions and EUA requests to assist FDA in reviewing in a timely manner. | 2024-11-21 | 2024 | 11 | https://www.federalregister.gov/documents/2024/11/21/2024-27085/510k-third-party-review-program-and-third-party-emergency-use-authorization-review-guidance-for | https://www.govinfo.gov/content/pkg/FR-2024-11-21/pdf/2024-27085.pdf | Health and Human Services Department; Food and Drug Administration | 221,199 | The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled "510(k) Third Party Review Program and Third Party Emergency Use Authorization (EUA) Review." This guidance provides FDA's current thinking... |