federal_register: 04-28252
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 04-28252 | Gastroenterology-Urology Devices; Classification for External Penile Rigidity Devices | Rule | The Food and Drug Administration (FDA) is classifying external penile rigidity devices intended to create or maintain sufficient penile rigidity for sexual intercourse into class II (special controls). FDA also is exempting these devices from premarket notification requirements. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of the guidance document that will serve as the special control for the device. | 2004-12-28 | 2004 | 12 | https://www.federalregister.gov/documents/2004/12/28/04-28252/gastroenterology-urology-devices-classification-for-external-penile-rigidity-devices | https://www.govinfo.gov/content/pkg/FR-2004-12-28/pdf/04-28252.pdf | Health and Human Services Department; Food and Drug Administration | 221,199 | The Food and Drug Administration (FDA) is classifying external penile rigidity devices intended to create or maintain sufficient penile rigidity for sexual intercourse into class II (special controls). FDA also is exempting these devices from premarket... |