WASHINGTON – The U.S. House passed a fee-reauthorization bill for the Food and Drug Administration on Wednesday that would triple the amount of time medical device companies have to report malfunctions of some higher-risk products.
The change, outlined in a statement included by reference in the bill, would give companies 90 days to report product malfunctions, replacing the current 30-day deadline. The bill would also allow companies to summarize previously reported product malfunctions, rather than filing detailed reports on each case.
The measure is part of a five-year piece of legislation that sets user fees device makers pay to the FDA to help the agency reduce the time it takes to review products and get them to market. The current fee bill expires this year.
Proponents say the changes would simplify the needlessly repetitive process of reporting known product problems. Critics warn that the policy may lead to even fewer reports of malfunctions that FDA officials already acknowledge are underreported. Either way, the bill would preserve the 30-day reporting requirement in cases in which a medical device causes or contributes to an actual patient injury. […]
An FDA spokeswoman on Wednesday declined to comment on the new policy while it is being considered by the Senate, except to point out that the proposal for quarterly summary reporting would not apply to cases of patient complications, injuries or deaths. […]
Consumer and research groups wonder whether the new rules would limit public access to information. Jack Mitchell of the National Center for Health Research said it’s already difficult for experts to recognize developing trends in implantable medical device problems, and the proposed change would not help.
“It will exacerbate the tendency to underreport,” Mitchell said. “Loosening up [the reporting rules] doesn’t seem to us a good idea.” […]
Medtronic, Boston Scientific and Abbott Laboratories, device makers with large Minnesota operations, declined to comment on the legislation Wednesday, referring questions to AdvaMed.
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