ANSWERS
02/06/1996

<TITLE> FDA EASES REGULATION OF LOW-RISK MEDICAL DEVICES </TITLE>
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T96-8                                              Sharon Snider
Feb. 6, 1996                                       (301) 443-3285

        FDA EASES REGULATION OF LOW-RISK MEDICAL DEVICES

     In keeping with its commitment to speed up patient access to
new medical devices, FDA is exempting 122 categories of low-risk
devices from premarket review, adding to the 450 categories
already exempted from such review.
     Since the exempted devices will no longer have to wait for
premarket review, they can reach patients sooner and FDA can
shift resources to more critical needs.
     This action is part of the drug and medical device reforms
announced last spring as part of the Clinton Administration's
National Performance Review.
     The types of devices exempted include gas pressure gauges,
oxygen masks, pacemaker chargers, dental floss, pneumatic
tourniquets, patient scales, examination lights, and therapeutic
massagers.
     These products will continue to be regulated by FDA and
remain subject to good manufacturing practice (GMP) regulations,
FDA factory inspections, and other general controls.  However,
the exemption  means that manufacturers will be allowed to market
the products without getting prior clearance from the agency.
                               -More-                         Page 2, T96-8, Low-Risk Medical Devices
     To exempt the products, the agency reclassified 111
categories of devices from Class II (medium risk) to Class I (low
risk).  In addition, the agency exempted 11 categories of devices
already in Class I.  The Medical Device Amendments to the Food,
Drug and Cosmetic Act and FDA regulations allow certain types of
Class I devices to be exempted from pre-market review.
     With this action, nearly three-fourths of all Class I
devices are now exempt from pre-market review.  This represents
one-third of all classified medical devices.
     The final regulation listing the 122 exempted device
categories goes into effect on February 15.  At that time, all
affected manufacturers who have pre-clearance submissions pending
FDA review will be notified by letter that their device is
exempt.
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