[Federal Register: October 16, 1998 (Volume 63, Number 200)] [Notices] [Page 55617-55630] From the Federal Register Online via GPO Access [wais.access.gpo.gov] [DOCID:fr16oc98-76] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 97D-0530] FDA Modernization Act of 1997: Modifications to the List of Recognized Standards; Availability; Withdrawal of Draft Guidance ``Use of IEC 60601 Standards; Medical Electrical Equipment'' AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) is announcing the publication of the modifications to the list of standards that will be recognized for use in the premarket review process and withdrawing its draft guidance entitled ``Use of IEC 60601 Standards; Medical Electrical Equipment.'' This will assist manufacturers who elect to declare conformity with consensus standards to meet all or part of medical device review requirements. DATES: This recognition of standards is effective on November 16, 1998; however, written comments concerning this notice may be submitted at any time. ADDRESSES: Submit written requests for single copies of ``Modifications to the List of Recognized Standards'' 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 requests, or fax your request to 301- 443-8818. Written comments concerning this document must be submitted to the contact person listed below. 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 guidance. This document may also be accessed via the Internet at FDA's web site ``http://www.fda.gov/cdrh''. FOR FURTHER INFORMATION CONTACT: To comment on this document and/or to recommend additional standards for recognition: James J. McCue, Jr., Center for Devices and Radiological Health (HFZ-101), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-594- 4766, ext. 137. SUPPLEMENTARY INFORMATION: I. Background Section 204 of the Food and Drug Administration Modernization Act of 1997 (FDAMA) (Pub. L. 105-115, 111 Stat. 2296 (1997)) amends section 514 of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360d), allowing the agency to recognize consensus standards established by international and national standards development organizations that may be used to satisfy identified portions of device premarket review submissions or other requirements. In a previous notice published in the Federal Register of February 25, 1998 (63 FR 9561), FDA announced the availability of a guidance document entitled ``Recognition and Use of Consensus Standards,'' which describes how FDA will implement that part of FDAMA, and provided the initial list of recognized standards (the February 1998 notice). This document announces modifications to the list of consensus standards to be recognized for use by FDA. II. Recognition and Use of IEC 60601 Standards In the Federal Register of January 13, 1998 (63 FR 1974), FDA published a notice that announced the availability of a draft guidance entitled ``Use of IEC 60601 Standards; Medical Electrical Equipment'' (the January 1998 notice). The purpose of the draft was to provide guidance to the Office of Device Evaluation reviewers on the use of the International Electrotechnical Commission (IEC) 60601 series of standards, including declarations of conformity to the standards, during the evaluation of premarket submissions for electrical medical devices. FDA has decided not to finalize this draft guidance document. Instead, recognition of the IEC 60601 standards will occur by listing in this publication ``Modifications to the List of Recognized Standards.'' There appears to be little, if any, benefit to finalizing guidance on FDA's use of IEC 60601 standards in a separate document from the general recognition of consensus standards under FDAMA, announced in the February 1998 notice, especially as there is a fair amount of overlap between the two documents. [[Page 55618]] In response to the January 1998 notice, FDA received one comment on the draft guidance. The comment contained some specific recommendations concerning IEC 60601-1-2 on Electromagnetic Compatibility (EMC). These recommendations were considered in developing the supplementary information sheet for this standard that is maintained on the FDA Web site. The comment also included recommended changes to the draft guidance which are now not necessary because the draft guidance will not be finalized. However, most of the recommended changes were accommodated in the guidance ``Recognition and Use of Consensus Standards'' announced in the February 1998 notice. Finally, the comment recommended an additional standard (newly published) in the 60601 series for recognition. This standard will be treated as an official recommendation according to the ``Guidance on the Recognition and Use of Consensus Standards'' and will be considered in due course. In the February 1998 notice, one of the recognized standards was IEC 60601-1. This ``Modifications to the List of Recognized Standards'' includes the IEC 60601-1 standard again because the associated supplementary information sheet has been modified, partly to include reference to the two amendments to IEC 60601-1 which are being recognized by this modified list. Also, some of the IEC 60601 part 2 standards referenced in the January 1998 notice do not appear in this modified list. This is because there was not sufficient time to complete the detailed evaluations and prepare the supplementary information sheets for these standards. They should appear in future Federal Register notices of recognized standards. III. List of Recognized Standards Modifications to the list of consensus standards to be recognized for use in premarket review and to meet other requirements are presented at the end of this document. This list is also maintained on the FDA Web site ``http://www.fda.gov/cdrh''. Also posted on the Web site are supplementary information sheets for each recognized standard. These information sheets list the address(es) where the standard can be obtained, information on any limitations on the application of the standard in medical device review or in satisfying other regulatory requirements, and a list of devices for which declarations of conformity with the recognized standard will be routinely accepted by agency reviewers. In addition to these documents, the web site contains answers to frequently asked questions regarding the use of recognized standards. In the February 1998 notice, one of the recognized standards, under the OB-GYN/GASTROENTEROLOGY heading, was ASTM D3492-96. This publication ``Modifications to the List of Recognized Standards'' removes the February 25, 1998, recognition and adds recognition of ASTM 3492-96 in part. The associated supplementary information sheet excludes from recognition the standards quality inspection for air burst properties and water leakage which are different than the FDA requirements. IV. Recommendation of Standards for Recognition by FDA Modifications to the list of recognized consensus standards related to medical devices will be announced in the Federal Register at least once a year, or more often if necessary. Any person may recommend consensus standards as candidates for recognition under the new paragraph of section 514 of the act by submitting such recommendations, with justification, to DSMA (address above). To be properly considered, such recommendations should contain, at a minimum, the following information: (1) Title of standard, (2) any reference number and date, (3) name and address of the nationally or internationally recognized standards development organization, (4) a proposed list of devices for which a declaration of conformity should routinely apply, and (5) a brief identification of the testing or performance or other characteristics of the device(s) that would be addressed by a declaration of conformity. V. Electronic Access In order to receive the guidance document ``Recognition and Use of Consensus Standards,'' 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 the second voice prompt press 2, and then enter the document number 321, 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 by 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 the guidance document ``Guidance on the Recognition and Use of Consensus Standards,'' as well as the list of recognized standards and details on their application, and information on obtaining copies. 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. VI. Comments Interested persons may, at any time, submit to the contact person listed above written comments regarding this notice. 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 will be considered in determining whether to amend the current guidance. Dated: October 8, 1998. William B. Schultz, Deputy Commissioner for Policy. 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