Gastroenterology-Urology Devices; Effective Date of Requirement for Premarket Approval of Testicular Prosthesis

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.