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.
Articles on the FDA Approval Process:
FDA Pressed to Speed Up Device OKs Before Fee Reauthorization
Study: No Safety Benefit Recognized From Slower, Burdensome FDA Approval Process for Devices
Minnesota Lawmakers Blast FDA Medical Device Policy
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