[Federal Register Volume 62, Number 114 (Friday, June 13, 1997)] [Notices] [Pages 32351-32352] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: 97-15452] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 97D-0209] Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers; Draft Guidance; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a draft guidance document entitled, ``Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers.'' This draft guidance is intended to assist the manufacturer in preparing a complete 510(k) premarket notification submission to the Center for Devices and Radiological Health (CDRH) or a third party reviewing organization. The agency is seeking public comment on the draft guidance. DATES: Written comments on the draft guidance document may be submitted by July 28, 1997. ADDRESSES: Submit written comments and requests for single copies of the draft guidance document to the Dockets Management Branch (HFA-305), Food and Drug Administration, 12420 Parklawn Dr., rm. 1-23, Rockville, MD 20857. See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance. FOR FURTHER INFORMATION CONTACT: Robert A. Phillips, Center for Devices and Radiological Health (HFZ-470), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20852, 301-594-1212. SUPPLEMENTARY INFORMATION: I. Background FDA is making this draft guidance document available in order to assist manufacturers preparing notification submissions for diagnostic ultrasound systems and transducers. In addition to basic information on submitting a 5l0(k) for these devices, the draft guidance contains specific information on device description, predicate device comparison, acoustic output reporting, general clinical safety and effectiveness, and labeling. The draft guidance also contains information on submitting a post-clearance special report called the ``510(k) special report'' providing production acoustic output values and other information. A guidance document does not bind FDA or the public, and it does not create or confer any rights, privileges, or benefits for or on any person, however, it does represent the agency's current thinking on the subjects discussed therein. The draft guidance document announced in this notice represents the agency's tentative thinking of the subjects discussed therein. II. Request for Comments Interested persons may, on or before July 28, 1997, submit to the Dockets Management Branch (address above) written comments on the draft guidance document. 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. Received comments may be seen in the office [[Page 32352]] above between 9 a.m. and 4 p.m., Monday through Friday. III. Electronic Access An electronic version of this draft guidance also is available via Internet using the World Wide Web (WWW) (connect to cdrh home page at http://www.fda.gov/cdrh/ode/usgudode.pdf). Dated: June 4, 1997. Joseph A. Levitt, Deputy Director for Regulations Policy, Center for Devices and Radiological Health. [FR Doc. 97-15452 Filed 6-12-97; 8:45 am] BILLING CODE 4160-01-F