federal_register: 04-5983

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document_number title type abstract publication_date pub_year pub_month html_url pdf_url agency_names agency_ids excerpts regulation_id_numbers
04-5983 Gastroenterology-Urology Devices; Classification for External Penile Rigidity Devices Proposed Rule The Food and Drug Administration (FDA) is proposing to classify external penile rigidity devices intended to create or maintain sufficient penile rigidity for sexual intercourse into class II (special controls). Also, FDA is giving notice of its intent to exempt this type of device from the premarket notification (510(k)) requirements of the Federal Food, Drug, and Cosmetic Act. After considering public comments on the proposed classification, FDA will publish a final regulation classifying these devices. This action is being taken to establish sufficient regulatory controls that will provide reasonable assurance of the safety and effectiveness of this device. Elsewhere in this issue of the Federal Register, FDA is publishing a notice announcing the availability of a draft guidance document that would serve as the special control for the devices if this proposal becomes final. 2004-03-17 2004 3 https://www.federalregister.gov/documents/2004/03/17/04-5983/gastroenterology-urology-devices-classification-for-external-penile-rigidity-devices https://www.govinfo.gov/content/pkg/FR-2004-03-17/pdf/04-5983.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA) is proposing to classify external penile rigidity devices intended to create or maintain sufficient penile rigidity for sexual intercourse into class II (special controls). Also, FDA is giving notice of its intent...  

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