ANSWERS 02/06/1996
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. ####