[Federal Register: September 10, 1998 (Volume 63, Number 175)] [Notices] [Page 48516-48517] From the Federal Register Online via GPO Access [wais.access.gpo.gov] [DOCID:fr10se98-100] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 98D-0670] Devices Used for In Vitro Fertilization and Related Assisted Reproduction Procedures: Submission Guidance for a 510(k); Draft; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ``Devices Used for In Vitro Fertilization and Related Assisted Reproduction Procedures: Submission Guidance for a 510(k).'' This draft guidance is neither final nor is it in effect at this time. This draft guidance outlines the information to be submitted in a premarket notification submission (510(k)) for medical devices that are intended to be used for in vitro fertilization (IVF), gamete intrafallopian transfer (GIFT), zygote intrafallopian transfer (ZIFT), intracytoplasmic sperm injection (ICSI), embryo transfer (ET), and related assisted reproduction technology (ART) procedures. DATES: Written comments concerning this draft guidance must be submitted by December 9, 1998. ADDRESSES: Submit written requests for single copies of the draft guidance entitled ``Devices Used for In Vitro Fertilization and Related Assisted Reproduction Procedures: Submission Guidance for a 510(k)'' to the Division of Small Manufacturers Assistance (HFZ-220), Center for Devices and Radiological Health, 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. Written comments concerning this draft guidance must be submitted to the Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Comments should be identified with the docket number found in the brackets in the heading of this document. See the SUPPLEMENTARY INFORMATION section for information on electronic access to the guidance. FURTHER INFORMATION CONTACT: Elisa D. Harvey, Center for Devices and Radiological Health (HFZ-470), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-594-1180. SUPPLEMENTARY INFORMATION: I. Background This draft guidance outlines the information to be submitted in a 510(k) for medical devices that are intended for use in IVF, GIFT, ZIFT, ICSI, ET, and ART procedures. On January 29, 1988, and October 21, 1995, FDA consulted with the Obstetrics and Gynecology Devices Panel (the Panel) regarding its regulatory strategy and the classification of these devices. Both times the Panel agreed that premarket approval is not necessary to provide reasonable assurance of the safety and effectiveness of the devices used for IVF and ART. Therefore, in the Federal Register of September 4, 1997 (62 FR 46686), FDA published a proposed rule to reclassify instrumentation intended for use in IVF and related ART procedures from class III to class II. FDA also proposed to reclassify assisted reproduction microscopes and microscope accessories from class III to class I and to exempt them from the requirement of premarket notification (510(k)). II. Significance of Guidance This draft guidance represents the agency's current thinking on the information needed in a 510(k) intended to be used for ART procedures. 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 developed good guidance practices (GGP's) to set forth the agency's policies and procedures for the development, issuance, and use of guidance documents (62 FR 8961, February 27, 1997). This draft guidance is a level 1 document consistent with the GGP's. III. Electronic Access In order to receive ``Devices Used for In Vitro Fertilization and Related Assisted Reproduction Procedures: Submission Guidance for a 510(k)'' via your fax machine, call the CDRH Facts-On-Demand (FOD) system at 800-899-0381 or 301-827-0111 from a touch-tone telephone. At the first voice prompt press 1 to access DSMA Facts, at second voice prompt press 2, and then enter the document number 620 followed by the pound sign (). Then follow the remaining voice prompts to complete your request. Persons interested in obtaining a copy of the draft guidance may also do so using the World Wide Web (WWW). The Center for Devices and Radiological Health (CDRH) maintains an entry on the WWW for easy access to information including text, graphics, and files that may be downloaded to a personal computer with access to the WWW. Updated on a regular basis, the CDRH home page includes ``Devices Used for In Vitro Fertilization and Related Assisted Reproduction Procedures: Submission Guidance for a 510(k),'' 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 [[Page 48517]] submissions, mammography matters, and other device-oriented information. The CDRH home page may be accessed at http://www.fda.gov/ cdrh. The draft guidance entitled ``Devices Used for In Vitro Fertilization and Related Assisted Reproduction Procedures: Submission Guidance for a 510(k)'' will be available at http://www.fda.gov/cdrh/ ode/ed--rp.html. IV. Comments Interested persons may, on or before December 9, 1998, submit to the Dockets Management Branch (address above) written comments regarding this draft guidance. Two copies of any comments are to be submitted, except that individuals may submit one copy. Comments are to be identified with the docket number found in brackets in the heading of this document. The draft guidance and received comments may be seen in the Dockets Management Branch between 9 a.m. and 4 p.m., Monday through Friday. Dated: August 25, 1998. D.B. Burlington, Director, Center for Devices and Radiological Health. [FR Doc. 98-24243 Filed 9-9-98; 8:45 am] BILLING CODE 4160-01-F