# Gastroenterology-Urology Devices; Effective Date of Requirement for Premarket Approval of Testicular Prosthesis
> **Food and Drug Administration** · Final rule. · Published 1995-04-05 · Effective 1995-04-05 · 60 FR 17208
## Document
- **Document number:** 95-8383
- **Category:** fda-device
- **Sub-agency:** Food and Drug Administration
- **Federal Register citation:** 60 FR 17208
- **CFR reference:** 21 CFR 876
- **Publication date:** 1995-04-05
- **Effective date:** 1995-04-05
- **HHS docket:** Docket No. 92N-0382
## Abstract

The Food and Drug Administration (FDA) is issuing a final rule to require the filing of a premarket approval application (PMA) or a notice of completion of a product development protocol (PDP) for the testicular prosthesis, a generic type of a surgically implanted medical device intended to simulate the presence of a testicle within the male scrotum. Commercial distribution of this device must cease, unless a manufacturer or importer has filed with FDA a PMA or a notice of completion of a PDP for its version of the testicular prosthesis within 90 days of the effective date of this regulation. This regulation reflects FDA's exercise of its discretion to require a PMA or notice of completion of a PDP for preamendments devices. EFFECTIVE DATE: April 5, 1995.

## Source
- [Federal Register document](https://www.federalregister.gov/documents/1995/04/05/95-8383/gastroenterology-urology-devices-effective-date-of-requirement-for-premarket-approval-of-testicular)
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