Northwestern University researchers have compared the results of their study — which found FDA requirements stifle medical device innovation — with the findings of an IOM study on the 510(k) process, an InHealth news release said.
The IOM report said that the review process was more "economical, faster and less burdensome to industry than the premarket approval application," but the survey respondents in Northwestern's study said the time was roughly the same.
Both studies agreed that the FDA lacks the staff to handle the volume of applications in a timely manner, that the ambiguous phrases "intended use" and "indications for use" are problematic, that the FDA inconsistently determines need for pre-clinical and clinical data and that the unpredictability of the 510(k) process is a barrier in medical device innovation.
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The IOM report said that the review process was more "economical, faster and less burdensome to industry than the premarket approval application," but the survey respondents in Northwestern's study said the time was roughly the same.
Both studies agreed that the FDA lacks the staff to handle the volume of applications in a timely manner, that the ambiguous phrases "intended use" and "indications for use" are problematic, that the FDA inconsistently determines need for pre-clinical and clinical data and that the unpredictability of the 510(k) process is a barrier in medical device innovation.
Related Articles on Medical Device Approval:
FDA Forms Expert Panel to Speed up Device Approval
FDA Continuing Work to Improve Sound Development of Medical Products
FDA Device Approval Process Stifles Innovation, Industry Survey Finds