During the next few months, manufacturers of certain in vitro diagnostic and radiology products may start to notice they are getting decisions on their premarket notification submissions, aka 510(k), sooner than expected. This will be due to a six-month pilot program called Triage, launched recently by the Food and Drug Administration’s (FDA) Office of In Vitro Diagnostic Device Evaluation and Safety, a part of the Center for Devices and Radiological Health (CDRH).

 …