U.S. House passes bill to lengthen time to report medical device malfunctions
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
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
Under the House bill, known as the FDA Reauthorization Act of 2017, companies would be able to ask the
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"AdvaMed supports the malfunction summary provision in the new user fee agreement,"
"Any incident involving serious injury or death is characterized as an adverse event, and therefore subject to
She added that quarterly summary reporting would only be allowed for malfunction incidents that are well-understood and familiar to the agency; any new type of malfunction incident not previously reported to the
"A lot of MDRs are really boilerplate and repetitive," DuVal said of the malfunction reports. "It would be nice to be able bundle them."
Consumer and research groups wonder whether the new rules would limit public access to information.
"It will exacerbate the tendency to underreport," Mitchell said. "Loosening up [the reporting rules] doesn't seem to us a good idea."
Dr.
"Here we have a policy that makes [the] industry happy but puts public health at risk," Carome said.
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