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...
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.