510(k) review cycle stability is indicator of meaningful reviews -- CDRH staffers.
This article was originally published in The Gray Sheet
Executive Summary
FDA 510(k) AVERAGE REVIEW CYCLES STEADY AT 1.67 per submission in fiscal 1995, Joseph Levitt, Deputy Director for Regulations and Policy, Center for Devices and Radiological Health, reported Dec. 13 at the Food and Drug Law Institute Educational Conference in Washington, D.C. The average cycle figure has been essentially constant since fiscal 1991, when it was also 1.67. "We have been running consistently over the last five years about an average of 1.6 cycles, and that has not changed," Susan Alpert, director of FDA's Office of Device Evaluation said at a separate FDLI session.