MASSDEVICE ON CALL —House Republicans introduced 10 bills aimed at the FDA’s medical device review and approval process.
The 10 bills, sent to the Energy & Commerce Committee, detailed proposed measures to reform the predictability, consistency and transparency of the federal watchdog agency’s med-tech review process.
The Republican signatories cautioned lawmakers that the U.S. would lose its position as a "world leader in medical device innovation unless the current regulatory environment at the FDA is reformed," reported Cardiovascular Business.
The proposed bills scored big praised from main med-tech lobby group AdvaMed.
"These bills reflect the Energy & Commerce Committee’s extensive work in examining the need for reform through hearing and debate. We support this effort because it is an excellent starting point in a legislative discussion that will address several important issues critical to maintaining our global leadership and competitiveness," said Stephen J. Ubl, president & CEO of AdvaMed, in prepared remarks.
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