AdvaMed cautions FDA against unnecessary changes to 510(k) process

06/13/2013 | MassDevice.com (Boston)

An FDA proposal to increase its oversight of 510(k) medical device modifications has received pushback from AdvaMed, which warned the new rules could lead to a greater number of 510(k) submissions without doing much to benefit patient safety. The current process has proven to be successful in maintaining timely review and patient safety, and "it is unclear that there is a real problem that needs to be solved," AdvaMed said in a white paper. The FDA is scheduled to hold a public meeting today to discuss possible changes.

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