510(k) quality review will include team analysis of selected SE/NSE decisions -- FDA memo.
This article was originally published in The Gray Sheet
Executive Summary
510(K) DECISION QUALITY REVIEW BY CDRH PANELS will be conducted under "blue book" memo I96-1, issued March 29 by the Office of Device Evaluation of FDA's Center for Devices and Radiological Health. The memo outlines a general framework for a revised 510(k) quality review program, which will include the establishment of quality review teams charged with reviewing random samples of substantially and not substantially equivalent 510(k)s from each of ODE's 18 branches.