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Compliance In Focus
Posted by John Lehmann on Wed, Feb 15, 2012

Will a More Rigorous FDA Equate to Longer 510(k) Clearance?

We ran across this interesting article in MD+DI.  According to a report released by the Emergo Group, the average time it takes to obtain 510(k) clearance has risen steadily in recent years.  The findings in the report indicated that the average number of days from submission to clearance increased every year from 2006 to 2010.

Industry has complained that if the process does not become more predictable, firms will increasingly seek initial clearance for products in Europe and other overseas markets. Over the past year FDA has also publicly acknowledged the problem.

The report also suggests that longer wait times could result in the FDA looking closer at submitted data providing an opportunity to ask more questions during the review process.  What could this mean? According to the report almost three-quarters of 510(k) submitters opt for the traditional route, instead of a special program. While the 510(k) process is suppose to provide an abbreviated pathway to submission, perhaps the industry has decided the lack of clarity with the 510(k) is a risk not worth taking.

For those considering the 510(k) pathway, IMARC recently published a whitepaper on this topic.  It elaborates on the current status of the process with regard to clinical data requirements, and defines some considerations that should be given to conducting a well-controlled clinical study if clinical data is required.

Are you confident that the FDA is committed to fixing this problem?  Share your thoughts with us.

Topics: Medical Devices, Emergo Group, FDA, 510(k)


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