federal_register: 98-34733
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| document_number | title | type | abstract | publication_date | pub_year | pub_month | html_url | pdf_url | agency_names | agency_ids | excerpts |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 98-34733 | External Penile Rigidity Devices; Proposed Classification for the External Penile Rigidity Devices | Proposed Rule | The Food and Drug Administration (FDA) is proposing to classify the generic type of external penile rigidity device including constriction rings, vacuum pumps, and penile splints for the management of erectile dysfunction. These devices fit on, over, or around the penis to support, promote, or maintain sufficient penile rigidity for sexual intercourse. Under the proposal, the external penile rigidity devices would be classified into class II (special controls). The agency is issuing in this document the recommendations of the Gastroenterology-Urology Advisory Panel regarding the classification of these devices. After considering public comments on the proposed classification, FDA will publish a final regulation classifying this device. This action is being taken to establish sufficient regulatory controls that will provide reasonable assurance of the safety and effectiveness of this device. | 1999-01-04 | 1999 | 1 | https://www.federalregister.gov/documents/1999/01/04/98-34733/external-penile-rigidity-devices-proposed-classification-for-the-external-penile-rigidity-devices | https://www.govinfo.gov/content/pkg/FR-1999-01-04/pdf/98-34733.pdf | Health and Human Services Department; Food and Drug Administration | 221,199 | The Food and Drug Administration (FDA) is proposing to classify the generic type of external penile rigidity device including constriction rings, vacuum pumps, and penile splints for the management of erectile dysfunction. These devices fit on, over,... |