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FDA ANNOUNCES MEDICAL/DEVICE TRACKING PROPOSAL

 FDA ANNOUNCES MEDICAL/DEVICE TRACKING PROPOSAL
 WASHINGTON, March 27 /PRNewswire/ -- The Food and Drug


Administration today proposed regulations to implement laws that require manufacturers of such medical devices as heart valves, breast implants and defibrillators to adopt effective systems for tracking their products from the manufacturer through the distribution chain to the patient.
 FDA Commissioner David A. Kessler, M.D., said: "Tracking will help FDA protect the public by providing the information necessary to quickly remove dangerous and defective devices from the market. Identifying and following patients who receive these devices is also critical, so that the patients can be notified promptly of any problems."
 The requirement is limited to permanent implants and life- sustaining or life-supporting devices, the failure of which could cause serious adverse health effects. Thus, the proposed regulations only apply to medical devices that have the potential for the most serious adverse health effects and for which the potential for recall is the greatest.
 Thirty-five types of devices from more than 370 manufacturers would be affected by the proposed regulation, which was mandated by the Safe Medical Devices Act of 1990. Of these, 30 meet the statutory criteria for tracking, and FDA designated five more because of the potential risk to the public health if they should fail. FDA could also designate additional devices to be tracked.
 "The tracking records would enable the manufacturer to locate patients and devices if serious problems occurred," Kessler said.
 Manufacturers would be required to design a system appropriate to their products. They would have to ensure that they could trace, identify and report to FDA the patients' names and locations of devices within three working days. Manufacturers would have to uniquely identify each device, set up a system to collect and maintain information for the useful life of the device and audit the data and functioning of the system every six months.
 No specific method of tracking has been specified by the proposed rule, and manufacturers would have the option to use different methods to ensure collection of information from patients or health care facilities. Whatever method a manufacturer chose, however, would have to be thorough; FDA envisions that often more than one means of data collection would be necessary to ensure effective tracking. For example, pre-addressed postcards given to patients to be returned to the manufacturer could be used as long as the manufacturer also made provisions to follow patients for changes in names or addresses through an additional method.
 The proposal was published in today's Federal Register. The public has 60 days to comment on the proposal. Comments may be sent to Dockets Management Branch, FDA-305, Room 1-23, 12420 Parklawn Drive, Rockville, Md. 20857.
 Comments will be considered carefully in preparing the final regulation. However, if for any reason it is not published by May 28, 1992, the Safe Medical Devices Act provides that the proposal automatically becomes final.
 FDA is one of the eight Public Health Service agencies within HHS.
 -0- 3/27/92
 /NOTE: Attention TV Broadcasters: Please use open caption for the hearing impaired./
 /CONTACT: Susan Cruzan of the Food and Drug Administration, 301-443-3285 or, after hours, 301-926-7081/ CO: Food and Drug Administration ST: District of Columbia IN: MTC SU:


DC-TW -- DC006 -- 2285 03/27/92 10:11 EST
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Date:Mar 27, 1992
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