FDA has put its proposals on the table for reforming the 510(k) pre-market clearance program, but the crucial activity will take place over the coming weeks as FDA fields comments and decides which initiatives will get the green light.
Shuren's Center: FDA Device Chief Discusses Long Road To 510(k) Reform
Article preview from "The Gray Sheet" - August 30, 2010
"The Gray Sheet" caught up with device center director Jeffrey Shuren Aug. 17 to discuss the impetus for the internal 510(k) report and how the agency's reform efforts will play out in the months, and years, to come.
"The Gray Sheet": How has the 510(k) report been received so far by industry and the public?
Jeffrey Shuren: Overall, generally positive. We've heard from folks that we have been listening to what they've been telling us and that there are some good ideas that were put on the table.
By the same token, many of the comments have been tempered - some from industry expressing concerns about some of the recommendations, although recognizing that the devil is in the details, and some on the consumer side saying we should go further than we have already (1 'The Gray Sheet' Aug. 9, 2010).
TGS: On that notion that the proposals could be beneficial but the devil is in the details: When and how will we have a better sense of how the broader concepts will be implemented?
Shuren: Following the close of the comment period, we'll vet all the comments that we've received and then make a call as to which recommendations we'll go ahead and adopt. Then we'll announce that to the public, describing those recommendations and what the timeline will be for implementation.
Recall, too, that for many of the recommendations, if we were to adopt them, they themselves have their open public input process. If we're going to draft a guidance, there will be an opportunity for the public to weigh in before we go final.
So there are lots of bites at the apple regarding the devil that may be in the details.
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