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House passes bill to accelerate FDA device review
WASHINGTON — The House of Representatives passed a bill Wednesday aimed at speeding the approval process for medical devices by the Food and Drug Administration, the New York Times reported.
According to the report, supporters of the bill said they were confident the Senate would pass a similar bill, perhaps with only modest changes. In its current wording, the bill will require device manufacturers to pay a user fee for the FDA, which will than be able to hire additional personnel for review of device approval applications. The bill seeks to reduce the reviewing process by 100 days from the average of 411 days the FDA now takes.
The bill would also allow manufacturers to hire independent, FDA-accredited inspectors to survey manufacturing facilities for federal compliance.