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[Federal Register: February 25, 1998 (Volume 63, Number 37)] [Notices] [Page 9569-9570] From the Federal Register Online via GPO Access [wais.access.gpo.gov] [DOCID:fr25fe98-97] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Guidance for Industry on Medical Device Appeals and Complaints: A Guidance on Dispute Resolution; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a guidance document entitled ``Medical Device Appeals and Complaints: A Guidance on Dispute Resolution.'' FDA currently has a myriad of dispute resolution and regulatory appeal processes that manufacturers of medical devices and radiological products can avail themselves of in situations where they disagree with a regulatory decision or action initiated by the agency. The agency's Center for Devices and Radiological Health (CDRH) is making this guidance document available in an effort to clarify these various processes and assist the industry in determining which process or processes are appropriate in a given circumstance. DATES: Written comments may be submitted at any time. ADDRESSES: Submit written comments concerning this guidance document to the contact person listed below. Submit written requests for single copies of the guidance document entitled ``Medical Device Appeals and Complaints: A Guidance on Dispute Resolution'' to the Division of Small Manufacturers Assistance, 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. See the SUPPLEMENTARY INFORMATION section for electronic access to the guidance. FOR FURTHER INFORMATION CONTACT: John F. Stigi, Center for Devices and Radiological Health (HFZ-220), Food and Drug Administration, 1350 Piccard Dr., Rockville, MD 20850, 301-443-7491. SUPPLEMENTARY INFORMATION: I. Background This guidance document represents an effort by the agency to catalogue the various types of processes for seeking and achieving resolution of disputes that arise between manufacturers of medical devices and radiological products and components of FDA that are involved in clinical, scientific, and regulatory decisionmaking that affects these industries. Although this guidance document does not advocate one process over another, it intends to: (1) Explain the dispute resolution processes that exist by virtue of Federal law, agency regulations, and administrative practices; and (2) provide general guidance on which processes are most suited for particular situations. In addition, the guidance document offers practical, easy- to-use information on how and where to file requests for reconsideration of agency actions and decisions, as well as requests for dispute resolution, and gives useful information that sets forth the variety of FDA and Department of Health and Human Services components that are responsible for reviewing, investigating, and resolving disputes and external complaints. Because dispute resolution processes for medical devices and radiological products and the agency components charged to administer them will likely undergo change over time, this guidance document is subject to periodic revision. For example, the recently enacted Food and Drug Administration Modernization Act of 1997 mandates the agency to establish discrete processes for the resolution of disputes related to the regulation of medical devices. The guidance document lays the groundwork for new agency procedures which, in the coming months, will be articulated in more detail and incorporated into the document. [[Page 9570]] This is a level 2 guidance document under FDA's Good Guidance Practices policy. This guidance document 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 the ``Medical Device Appeals and Complaints: A Guidance On Dispute Resolution'' guidance document 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 (396) followed by the pound sign (#). Then follow the remaining voice prompts to complete your request. Persons interested in obtaining a copy of the guidance document 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 PC with access to the Web. The CDRH home page is updated on a regular basis and includes the ``Medical Device Appeals and Complaints: A Guidance On Dispute Resolution'' guidance document, 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. ``Medical Device Appeals and Complaints: A Guidance On Dispute Resolution'' is also available on the medical device reporting page at http://www.fda.gov/cdrh/modact/modern.html. 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. Request for Comments Interested persons, may at any time, submit to the contact person listed above written comments regarding this guidance document. Comments will be considered in determining whether to revise or revoke the guidance. Dated: February 11, 1998. D. B. Burlington, Director, Center for Devices and Radiological Health. [FR Doc. 98-4842 Filed 2-20-98; 4:00 pm] BILLING CODE 4160-01-F
Updated 2/25/1998
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