The 12%: Diagnostics “Quick Reviews” Make A Mark, FDA Official Says
This article was originally published in The Gray Sheet
Executive Summary
The first month of the diagnostics office’s “triage” pilot program has led to quicker reviews for some 510(k)s, an agency official reports. To qualify for the program's quick-review pathway, a submission must be of high quality and free of certain time-consuming complexities.
You may also be interested in...
CDRH Dx Office Integrates 30-Day Quick-Reviews Into 510(k) Program
Following a successful 30-day review pilot last fall, CDRH’s diagnostics office started incorporating the quick-review process into its overall 510(k) review program in January. The Office of Device Evaluation is considering following suit.
FDA Claims Short-Term Success For Pre-Market Device Reforms
With many of its 510(k) and science reforms at least partially implemented, CDRH says it is seeing tangible, positive results. The device center cites a turnaround on multiple measures of review performance following the lows of 2010.
Washington Roundup, August 2012
The latest medical device regulatory and reimbursement news from Elsevier Business Intelligence’s “The Gray Sheet.” This month we report on recent FDA proposals to streamline the 510(k) and PMA submission processes and the ongoing investigation into FDA surveillance of CDRH employee whistleblowers.