The Food and Drug Administration device approval process has added more layers of costly clinical requirements within the past three years, according to a survey of device developers, which confirmed the anecdotal concerns of some observers.
Approval process tougher, devicemakers say
A survey of 350 medical-device developers released Tuesday by Northwestern University researchers reported that 58% of them have experienced expanded agency requirements in recent years for clinical studies and analyses. It is a finding that reflects other recent industry opinion reviews that the medical device approval process has become both more demanding and less predictable in recent years.
“These all say that the FDA is requiring more clinical data in submissions, which is the most costly kind of requirement,” Peter Hutt, a medical-device attorney, said at a presentation of the data.
The greater scrutiny is not justified by any widespread proven safety problems, according to industry advocates, and it is driving devicemakers—especially smaller ones—to seek approval instead in other markets, such as Europe.
Dr. Jeffrey Shuren, director of the FDA's Center for Devices and Radiological Health said the actual rate of clinical studies required for all medical device applicants is “significantly less” than the rate found in the survey. But he acknowledged that the agency needs to make some improvements to the process, including informing companies earlier in the application process that they will likely need to provide more information to receive marketing approval for their product.
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