Consumers Union, the policy and advocacy arm of Consumer Reports, has issued a statement that said the FDA's Safety and Innovation Act includes improvements over current law, but the bill leaves a number of "significant flaws with the FDA's current medical device oversight system unaddressed," according to a news release.
The statement came after the Senate Health, Education, Labor and Pensions (HELP) Committee approved the bill.
Consumers Union said it offered a number of suggestions for improvement of the bill to the HELP Committee, including prohibiting clearance of new medical devices based on recalled ones; improving the monitoring of devices once they are cleared for sale; providing FDA with greater authority to require post-market safety studies; and retaining current strong conflict of interest standards.
"The FDA's current fast track review process has allowed too many dangerous and defective devices onto the market," said Lisa McGiffert, director of Consumers Union's Safe Patient Project, in the release. "To make matters worse, the FDA doesn't have the tools it needs to react quickly when safety problems with medical devices arise. Unfortunately, this bill doesn't fix some of the most serious flaws in our current system and leaves patients at risk."
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