Proprosed Pilot Triage Program
Submitted by kBLASTER Team on
FDA on April 2, 2012 released pilot program for accelerated review of 510(k) submissions to Office of In Vitro Diagnostic Device Evaluation and Safety (OVID) for submissions that meet the Quick Review criteria. OVID regulates all aspects of in-home and laboratory diagnostic tests (in vitro diagnostic devices, or IVDs). This Quick Review process is intended to clear the submission as soon as possible but within 30 days.
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