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FDA Plans To Audit Its New 510(k) Refuse-To-Accept Program

Results of the planned June audit will be of significant interest to a number of device companies that claim FDA reviewers have erroneously crossed into substantive review territory in applying the new "quick review" procedure.

FDA plans to conduct an internal audit of its new 510(k) refuse-to-accept program this June.

The 15-day quick-review program involves the use of a checklist by FDA reviewers to see if a 510(k) submission contains all of the required documentation and is

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