In meetings with devicemakers, FDA officials have acknowledged concerns over the time it takes for medical devices to go through the 510(k) approval process, according to a report by MedCity News.
Agency officials said although they have not seen lengthier review times on their end, the total time had increased, "driven by a combination of increasing numbers of cycles and increasing time industry takes for each cycle," they said. The officials suggested the longer decision-making times should be addressed in the next user-fee reauthorization.
FDA officials added they were "not bound" to adopt recommendations from the Institute of Medicine in an upcoming IOM report the agency had commissioned.
Read the MedCity News report on the FDA approval process.
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