A “Disastrous” Draft? Device Firms Take Issue With 510(k) Modifications Guidance
By
Jessica Bylander / Email the Author / “The Gray Sheet” Dec. 5, 2011, Vol. 37, No. 49
Regulatory / Word Count: 1197 / Article # 01111205007
Executive Summary
Draft guidance on when to submit a 510(k) for a change to a previously cleared device could increase the number of submissions by two- or three-fold, device makers say. Some call for draft to be withdrawn.
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