[Federal Register Volume 63, Number 214 (Thursday, November 5, 1998)] [Notices] [Pages 59794-59795] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: 98-29565] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 98D-0729] Draft ``Guidance on the Content and Format of Premarket Notification [510(k)] Submissions of Washers and Washer-Disinfectors;'' Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled ``Guidance on the Content and Format of Premarket Notification [510(k)] Submissions of Washers and Washer-Disinfectors.'' This draft guidance is not final nor is it in effect at this time. FDA recognizes the importance of providing applicants and other interested parties the agency's 510(k) submission criteria for washers and washer-disinfectors intended to process reusable medical devices. The intent of this draft guidance is to provide specific directions regarding information and data which should be submitted to FDA in 510(k) submission for these types of devices. This draft guidance is posted on the Internet and will be included in the panel package for the formal classification of these devices at the General Hospital and Personal Use Devices Panel meeting on September 14, 1998. DATES: Written comments concerning this guidance must be received by February 3, 1999. ADDRESSES: Submit written requests for single copies of the draft guidance entitled ``Guidance on the Content and Format of Premarket Notification [510(k)] Submissions of Washers and Washer-Disinfectors'' to the Division of Small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 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 brackets in the heading of this document. Submit written comments on ``Guidance on the Content and Format of Premarket Notification [510(k)] Submissions of Washers and Washer-Disinfectors'' to the contact person listed below. See the Supplementary Information section for information on electronic access to the guidance. FOR FURTHER INFORMATION CONTACT: Chiu S. Lin, Center for Devices and Radiological Health (HFZ-480), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-443-8913. SUPPLEMENTARY INFORMATION: I. Background Washers and washer-disinfectors intended for cleaning and disinfection of reusable medical devices, such as stainless steel devices, surgical instruments, including devices with lumens, respiratory therapy equipment, and other medical devices, were legally marketed devices prior to the enactment of the Medical Device Amendments of 1976. These devices are considered ``unclassified'' medical devices. On June 2, 1998, FDA published on the Internet a guidance document entitled ``CDRH Guidance Document for Washers and Washer-Disinfectors Intended for Processing Reusable Medical Devices'' to provide direction to the regulated industry on when a premarket notification [510(k)] submission is required for these unclassified washers and washer-disinfectors. In the ``CDRH Guidance Document for Washers and Washer-Disinfectors Intended for Processing Reusable Medical Devices,'' the agency made the commitment to provide industry with guidance on the information and data which should be included in a 510(k) submission. This draft guidance entitled ``Guidance on the Content and Format of Premarket Notification [510(k)] Submissions of Washers and Washer-Disinfectors'' provides regulated industry with specific guidance on the information and data that should be included in a 510(k) submission for these devices. These unclassified washers and washer-disinfectors will undergo formal classification at the September 14, 1998, General Hospital and Personal Use Devices Panel meeting. II. Significance of Guidance This draft guidance represents the agency's current thinking on the [[Page 59795]] information and data which should be included in a 510(k) submission for the washers and washer-disinfectors intended to process reusable medical 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 (62 FR 8961, February 27, 1997). This guidance document is issued as a Level 1 guidance consistent with GGP's. III. Electronic Access In order to receive ``Guidance on the Content and Format of Premarket Notification [510(k)] Submissions of Washers and Washer- Disinfectors'' 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 1252 followed by the pound sign (#). Then follow the remaining voice prompts to complete your request. Persons interested in obtaining a copy of the guidance may also do so using the World Wide Web (WWW). 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 Web. Updated on a regular basis, the CDRH home page includes ``Guidance on the Content and Format of Premarket Notification [510(k)] Submissions of Washers and Washer-Disinfectors,'' 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''. ``Guidance on the Content and Format of Premarket Notification [510(k)] Submissions of Washers and Washer-Disinfectors'' will be available at ``http://www.fda.gov/cdrh/ode/Edxdn.HTML''. IV. Comments Interested persons may, on or before February 3, 1999, submit to 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: September 8, 1998. D.B. Burlington, Director, Center for Devices and Radiological Health. [FR Doc. 98-29565 Filed 11-4-98; 8:45 am] BILLING CODE 4160-01-F