FREE ON-DEMAND WEBINAR
March 23, 2023

Refuse to Accept (RTA) & Additional Information Requests (AIR): How to Avoid Problems with Your Medical Device Submission

Despite FDA publishing multiple Refuse-To-Accept (RTA) guidance documents for all major medical device submission types, including the 510(k), de novo and PMA, more than two-thirds of all medical device submissions result in an Additional Information Request (AIR) and/or are rejected upon administrative review, i.e. RTA (see MDUFA statistics here).

Regrettably, when a submission is rejected on administrative review, it is solely the fault of the company not the FDA!

During this webinar we will review the available RTA checklists and, most importantly, you will learn how to design a submission that will pass administrative review and avoid receiving an AIR or RTA determination, which will undoubtedly lead to delays in getting your device to market!

Simply put: whether we need them or not, FDA has published these RTA checklists… We might as well use them to our advantage!