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Compliance In Focus
Posted by John Lehmann on Tue, Jan 29, 2013

Is the Medical Device Review Process Improving?

Is the Medical Device Review Process Improving?For quite some time we’ve watched the blame for slow review times pass between industry and FDA. One side claims the pathway to approval lacks transparency and predictability, the other claims the submissions are of poor quality. But could this coming year be the start of a new relationship between FDA and industry?

Recently an article was posted in MD+DI which examines the question, “CDRH Says It has Improved Its Processes, Do you Agree?” This question prompts a review of those items CDRH listed as priorities; for reference, the priorities include:

For more information on the CDRH’s 2013 Strategic Priorities which “aims to reset the direction of CDRH toward smart regulation.”  In fact, you can check out the report published “Improvements in Device review.” However, as strongly put in the MD+DI article, “Better than glossy reports is more meaningful transparency from the center.”

What are your thoughts on the processes of CDRH? Do you think the six priorities listed above hit the mark for industry and patients? Share your opinions below.

Photo Credit: Sebastian.YEPES

Significant Risk/Non-Significant Risk Determination

Topics: Medical Device Review Process, FDA, CDRH, MD+DI


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