WASHINGTON - Medical device manufacturers are unhappy with parts of a new Food and Drug Administration rule regarding their reports of device malfunctions, in part because the FDA admits manufacturers' paperwork will double. But a manufacturer no longer will have to report malfunctions if it can get medical proof that a device did not contribute to a death or serious injury.
Under the rule, published in December, medical facilities must report serious device-related incidents or failures to FDA within 10 days. Deaths must be reported directly to FDA and the manufacturer.
Serious injuries must be reported to the maker, and health facilities must file summaries with FDA every six months.
FDA previously required notification in five days - and that limit continues if the manufacturer must recall a medical device to prevent ``unreasonable'' risk of great harm to public health.
The new rule goes into effect April 11. A 1991 rule proposal on the reporting requirements received more than 300 public comments, the agency said.
"The final FDA rule imposes considerable burdens on U.S. and foreign manufacturers for which criminal and civil penalties will be pursued by the FDA,'' said Larry R. Pilot, counsel to the Washing-ton-based Medical Device Manu-facturers Association.
``The FDA estimates that the number of reports annually will increase by 50 percent, to 150,000,'' he added.
MDMA also objects to the rule's annual certification of certain data by a manufacturer's chief executive, or designated U.S. agent of a foreign company.