News
03/27/1992

<TITLE>Marufacturers of Heart Valves, Breast Implants & Defibrillators to Track Product</TITLE>
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P92-9                                       Food and Drug Administration
FOR IMMEDIATE RELEASE                       Susan Cruzan - (301) 443-3285

    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 l990.  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," Dr. 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, l992,  
the Safe Medical Devices Act provides that the proposal automatically         
becomes final.    
    FDA is one of the eight Public Health Service agencies within HHS.
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