federal_register: 2024-19414
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 2024-19414 | Medical Devices and Device-Led Combination Products; Voluntary Malfunction Summary Reporting for Manufacturers | Rule | The Food and Drug Administration (FDA, Agency, or we) is announcing a minor, technical modification to an alternative that permits manufacturer reporting of certain device malfunction medical device reports (MDRs) in summary form on a quarterly basis. We refer to this alternative as the "Voluntary Malfunction Summary Reporting Program." | 2024-08-29 | 2024 | 8 | https://www.federalregister.gov/documents/2024/08/29/2024-19414/medical-devices-and-device-led-combination-products-voluntary-malfunction-summary-reporting-for | https://www.govinfo.gov/content/pkg/FR-2024-08-29/pdf/2024-19414.pdf | Health and Human Services Department; Food and Drug Administration | 221,199 | The Food and Drug Administration (FDA, Agency, or we) is announcing a minor, technical modification to an alternative that permits manufacturer reporting of certain device malfunction medical device reports (MDRs) in summary form on a quarterly basis.... |