[Federal Register Volume 62, Number 243 (Thursday, December 18, 1997)] [Notices] [Pages 66373-66374] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: 97-33090] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 97N-0517] Changes in Medical Device Tracking and Postmarket Surveillance Authority AGENCY: Food and Drug Administration, HHS. ACTION: Notice of meeting. ----------------------------------------------------------------------- The Food and Drug Administration (FDA) is announcing the following meeting: Changes in medical device tracking and postmarket surveillance authority under the Food and Drug Administration Modernization Act of 1997. The topic to be discussed is postmarket controls, including tracking and/or surveillance of devices. Date and Time: The meeting will be held on January 15, 1998, 9 a.m. to 3 p.m. Location: The meeting will be held at the University of Maryland Auditorium, 9640 Gudelsky Dr., Rockville, MD. Contact: Casper E. Uldriks, Center for Devices and Radiological Health (HFZ-300), Food and Drug Administration, 2098 Gaither Rd., Rockville, MD 20850, 301-594-4692, FAX 301-594-4610. Registration and Requests for Oral Presentations: Send registration information (including name, title, firm name, address, telephone, and fax number) and written material and requests to make oral presentations to the contact person by January 5, 1998. Written comments may be submitted to the Dockets Management Branch (HFA-305), Food and Drug Administration, 12420 Parklawn Dr., rm. 1-23, Rockville, MD 20857, by January 5, 1998. If you need special accommodations due to a disability, please contact Casper E. Uldriks at least 7 days in advance of the meeting. Transcripts: Transcripts of the meeting may be requested in writing from the Freedom of Information Office (HFI-35), Food and Drug Administration, 5600 Fishers Lane, rm. 12A-16, Rockville, MD 20857, approximately 15 working days after the meeting at a cost of 10 cents per page. The agency is interested in discussing the statutory changes concerning tracking and postmarket surveillance under the Food and Drug Administration Modernization Act of 1997 and whether the agency should develop additional criteria to use to determine whether tracking or postmarket surveillance requirements should be ordered by FDA. The agency would like to supplement the statutory criteria with additional nonbinding criteria to help determine which devices may need to be added or removed from the list of devices subject to tracking and/or postmarket surveillance requirements. FDA intends to publish its revised lists by February 19, 1998, the effective date of the new law. By way of example, additional criteria that would support a tracking order might include the likelihood of a recall, or the likelihood of irreversible clinical outcomes. Additional criteria that might not support a tracking order, for example, might include current, standard clinical practices that mitigate risk. Additional criteria that would support a postmarket surveillance order might include, for example, the use of a new technology or the need to assess a new public health issue based on measurable outcomes. Additional criteria that would not support a [[Page 66374]] postmarket surveillance order, for example, might be whether there are alternative postmarket data collection mechanisms to obtain the same kind of information about the device. The agency could use such criteria to guide its decision whether to impose tracking or postmarket surveillance in a particular case. The agency requests that comments or presentations be provided concerning the statutory requirements for medical device tracking and postmarket surveillance and related proposed risk assessment criteria which may be useful to the agency to determine whether tracking orders or postmarket surveillance orders should be issued for devices that meet the basic statutory requirements of section 519(e) or 522 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360i(e) or 360l). The agency would like to encourage comments, discussion and proposals from the industry, the professional community, consumers, and any other interested parties or organizations. Written comments may be submitted in advance of the meeting to the Dockets Management Branch (address above). To help focus discussion, FDA requests answers to the following questions: (1) What factors (or criteria) should lead FDA to order tracking and/or postmarket surveillance? (2) What factors (or criteria) should lead FDA not to order tracking and/or postmarket surveillance? (3) Under what circumstances should FDA order both tracking and postmarket surveillance for a device? (4) Under what circumstances should FDA order tracking but not postmarket surveillance, or vice versa? Electronic Access Additional information regarding the public meeting may be found on the Internet on the home page for the Center for Devices and Radiological Health under the ``New Items on the Internet'' section at www.cdrh.fda.gov. This will be an informal meeting conducted in accordance with 21 CFR 10.65. Dated: December 15, 1997. Joseph A. Levitt, Deputy Director for Regulations Policy, Center for Devices and Radiological Health. [FR Doc. 97-33090 Filed 12-15-97; 3:02 pm] BILLING CODE 4160-01-F