New FDA Guidance Aims To Speed Medical Device Reviews

Law360, New York (August 10, 2012, 6:36 PM EDT) -- The Food and Drug Administration on Friday released a new draft guidance it said would speed up the 510(k) medical device review process by making it simpler for reviewers to refuse to accept incomplete applications.

The guidance will replace two former guidances dealing with the "refusal to accept" process, which the FDA said were overly broad and did not lay out specific content that sponsors must include in their 510(k) notification. The guidances had been in effect since 1993 and 1994.

"As a result, FDA accepts...
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