2 January 1998
Source:
http://www.access.gpo.gov/su_docs/aces/aces140.html
[Federal Register: January 2, 1998 (Volume 63, Number 1)] [Notices] [Page 89] From the Federal Register Online via GPO Access [wais.access.gpo.gov] [DOCID:fr02ja98-47] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 97D-0514] CDRH Interim Regulatory Policy for External Penile Rigidity Devices; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) is making available a policy from its Center for Devices and Radiological Health (CDRH) entitled ``CDRH Interim Regulatory Policy for External Penile Rigidity Devices.'' The document outlines several changes in how FDA regulates external penile rigidity devices including constriction rings, vacuum pumps, and penile splints. DATES: Written comments concerning this guidance may be submitted at any time. ADDRESSES: Written comments concerning this guidance must be submitted to the contact person. Comments should be identified with the docket number found in brackets in the heading of this document. See the SUPPLEMENTARY INFORMATION section for electronic access to the policy. Submit written requests for single copies of the ``CDRH Interim Regulatory Policy for External Penile Rigidity Implants'' to the Division of Small Manufacturers Assistance, Center for Devices and Radiological Health (HFZ-220), Food and Drug Administration, 1350 Piccard Dr., Rockville, MD 20850. Send two self-addressed adhesive labels to assist that office in processing your request, or fax your request to 301-443-8818. FOR FURTHER INFORMATION CONTACT: Donald St. Pierre, Center for Devices and Radiological Health (HFZ-450), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-594-2194. SUPPLEMENTARY INFORMATION: I. Background External penile rigidity devices are unclassified medical devices designed to promote or maintain sufficient penile rigidity for sexual intercourse. This document clarifies when premarket review is required for new external penile rigidity devices using a uniform approach. The new policy also allows manufacturers the option of marketing external penile rigidity devices as prescription and/or over the counter (OTC) devices. This guidance document represents the agency's current thinking on regulation of external penile rigidity devices. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the applicable statute, regulations, or both. The agency has adopted Good Guidance Practices (GGP's), which set forth the agency's policies and procedures for the development, issuance, and use of guidance documents (61 FR 8961, February 27, 1997). This guidance is issued as Level 2 guidance consistent with GGP's. II. Electronic Access Persons interested in obtaining a copy of the guidance may do so using the World Wide Web (WWW). The Center for Devices and Radiological Health (CDRH) maintains an entry on the World Wide Web for easy access to information including text, graphics, and files that may be downloaded to a personal computer with access to the Web. Updated on a regular basis, the CDRH Home Page includes the CDRH Interim Regulatory Policy for External Penile Rigidity Devices, device safety alerts, Federal Register reprints, information on premarket submissions (including lists of approved applications and manufacturers' addresses), small manufacturers' assistance, information on video conferencing and electronic submissions, mammography matters, and other device-oriented information. The CDRH home page may be accessed at http://www.fda.gov/cdrh. The CDRH Interim Regulatory Policy for External Penile Rigidity Devices will be available at http://www.fda.gov/cdrh/ode/expenrig.html. A text-only version of the CDRH Web site is also available from a computer or VT-100 compatible terminal by dialing 800-222-0185 (terminal settings are 8/1/N). Once the modem answers, press Enter several times and then select menu choice 1: FDA BULLETIN BOARD SERVICE. From there follow instructions for logging in, and at the BBS TOPICS PAGE, arrow down to the FDA home page (do not select the first CDRH entry). Then select Medical Devices and Radiological Health. From there select CENTER FOR DEVICES AND RADIOLOGICAL HEALTH for general information, or arrow down for specific topics. III. Comments Interested persons may at any time submit written comments on the guidance document to the contact person. Comments will be considered in determining whether to revise or revoke the guidance document. Dated: December 1, 1997. Joseph A. Levitt, Deputy Director for Regulations Policy, Center for Devices and Radiological Health. [FR Doc. 97-34158 Filed 12-31-97; 8:45 am] BILLING CODE 4160-01-F