In the context of medical device Regulatory Affairs, a Refusal to Accept (RTA) is a request from the US FDA for additional information or clarification on information submitted in a 510(k) application.
To ensure the safety and efficacy of medical devices entering the US market, the US FDA requires every manufacturer to submit a mandatory 510(k) pre-market notification. It is mainly applicable for Class II devices and a few Class I and Class III devices and is based on the principle of substantial equivalence. According to this principle, the new device should demonstrate substantial equivalence of safety and efficacy with a predicate device, which is legally marketed in the US.
