Primer on U.S. FDA's new 510(k) refuse to accept policy

Primer on U.S. FDA's new 510(k) refuse to accept policy-massdevice: The US Food and Drug Administration's revised Refuse to Accept (RTA) policy (links to PDF document) for 510(k) applications that lack all required documentation is now in effect. Medical device manufacturers planning to undergo the premarket notification process should familiarize themselves with steps necessary to get their applications back on track in the event that they receive an RTA notice from the FDA.