[Federal Register Volume 63, Number 90 (Monday, May 11, 1998)] [Notices] [Page 25865] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: 98-12311] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 97N-0362] The New 510(k) Paradigm; Alternate Approaches to Demonstrating Substantial Equivalence in Premarket Notifications; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled ``The New 510(k) Paradigm-Alternate Approaches to Demonstrating Substantial Equivalence in Premarket Notifications.'' The New 510(k) Paradigm presents two alternative methods, in addition to the traditional method, of demonstrating substantial equivalence in premarket notifications and is intended to conserve FDA's review resources while facilitating the introduction of safe and effective devices into interstate commerce. The New 510(k) Paradigm addresses the type of information needed in premarket notification submissions, by the Center for Devices and Radiological Health (CDRH), to render substantial equivalence determinations. DATES: May 11, 1998. ADDRESSES: Submit written requests for single copies on a 3.5'' diskette of ``The New 510(k) Paradigm-Alternate Approaches to Demonstrating Substantial Equivalence in Premarket Notifications,'' to the Division of Small Manufacturers Assistance (DSMA), 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. Comments should be identified with the docket number found in brackets in the heading of this document. See the SUPPLEMENTARY INFORMATION section for information on electronic access to the guidance. FOR FURTHER INFORMATION CONTACT: Philip J. Phillips, Center for Devices and Radiological Health (HFZ-400), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-594-2022. SUPPLEMENTARY INFORMATION: I. Background Under section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360(k)), a person who intends to introduce a device into commercial distribution is required to submit a premarket notification, or 510(k), to FDA at least 90 days before commercial distribution is to begin. Section 513(i) of the act (21 U.S.C. 360c(i)) states that FDA may issue an order of substantial equivalence, only upon making a determination that the device to be introduced into commercial distribution is as safe and effective as a legally marketed device. Under 21 CFR 807.87, FDA has codified the content requirements for premarket notifications to be submitted by device manufacturers in support of a substantial equivalence decision. FDA has, however, discretion in the type of information it deems necessary to meet those content requirements. While the Paradigm maintains the traditional method of demonstrating substantial equivalence under section 510(k) of the act, it also presents two alternatives. The first alternative, the ``Special 510(k): Device Modification,'' utilizes certain aspects of the Quality System regulation, while the second alternative, the ``Abbreviated 510(k),'' relies on the use of FDA guidance documents, special controls and FDA recognized consensus standards to facilitate 510(k) review. In the Federal Register of September 19, 1997 (62 FR 49247), FDA published a notice of availability of a draft of this guidance document on the Paradigm. FDA received 13 comments on the draft. FDA reviewed these comments and has made revisions to the guidance as appropriate. This guidance document represents the agency's current thinking on the 510(k) Paradigm. 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. II. Electronic Access In order to receive ``A New 510(k) Paradigm-Alternate Approaches to Demonstrating Substantial Equivalence in Premarket Notifications,'' 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 905 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: 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. 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 to the contact person named above written comments regarding this guidance document. Comments will be considered in determining whether to revise or revoke the guidance. Dated: May 1, 1998. D.B. Burlington, Director, Center for Devices and Radiological Health. [FR Doc. 98-12311 Filed 5-8-98; 8:45 am] BILLING CODE 4160-01-F