ANSWERS
12/11/1995

<TITLE> NEW MEDICAL DEVICE PROBLEM REPORTING RULE </TITLE>
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T95-66                                    Sharon Snider
Dec. 11, 1995                             (301) 443-3285

NEW MEDICAL DEVICE PROBLEM REPORTING RULE

     Less costly and more streamlined reporting of medical
device-related serious incidents -- changes that are expected to
strengthen FDA's post-marketing "safety net" -- has been made
mandatory by a new rule announced today by the agency.
     The rule for the first time requires hospitals, nursing
homes and other health care facilities to report deaths and
serious injuries or illnesses connected with the use of medical
devices.  It will also provide the necessary backup assurance of
product safety to enable FDA to clear innovative devices for
marketing more quickly.
     The new rule, published today as a final regulation,
incorporates more than 300 public comments received in response
to the agency's 1991 proposed regulation.  
     Under the final rule, medical facilities must report all
serious device-related incidents within 10 days.  Deaths must be
communicated directly to the agency as well as to the
manufacturer, and serious injuries or illnesses must be reported
to the manufacturer, or to FDA if the firm's identity is not 
known. The facilities must send every six months a summary of
these reports to FDA.
                             -More-                               
                                        Page 2, T95-66, MDR
     Manufacturers have been given five days to report to FDA any
device-related incident that requires immediate action to protect
the public health, as well as any incident whose report is
requested by the agency.  The time limit for the rest of the
manufacturers' reports to FDA on device-related deaths, serious
injuries or illness is 30 days.  This gives manufacturers time to
investigate incidents and provide FDA with detailed information
on adverse events.
     Manufacturers also must submit to FDA annual statements
certifying the number of reports filed or that no reports were
filed during the previous 12 months.  Device manufacturers are
responsible for reporting incidents related to their products
even if they are no longer being marketed. 
     The new rule achieves a significant cost reduction by
cutting down on paperwork.  It allows medical device reports to
be submitted on the same Medwatch form used to report drug and
biologic related adverse events.  Reporting will be enhanced by
new agency procedures, currently under development, which will
make possible the filing of Medwatch reports electronically.
     Proposed education and training requirements for medical 
facilities have been eliminated from the final rule, resulting in
a cost reduction of $31 million.
     Today's announcement completes the implementation of a 
universal "alert system" required by the Safe Medical Devices Act
of 1990 and the Medical Device Amendments of 1992.  The final
rule will go into effect 120 days after today's publication in
the Federal Register.
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