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!

Watch the webinar

M.DruesGG webinar 3-23-23
In his signature style, Dr. Michael Drues will use actual devices as case studies to discuss:
  • The FDA review process: administrative review vs. substantive/scientific review
  • Actual (not hypothetical) examples of AIRs and RTAs from real medical device submissions
  • Practical and actionable advice on how to avoid RTA determinations
  • Advice on using electronic tools to minimize RTA determinations
  • Strategies on how to deal with AIRs and RTAs should you receive one
Who should attend? 
  • Regulatory Affairs Professionals & Management 
  • Quality Professionals and Management 
  • Medical Device Executives 
  • Product Development Engineers and Management
Register Now  

Hosted by

Laura Court

Medical Device Guru,
Greenlight Guru


About Greenlight Guru

Greenlight Guru is the leading cloud-based platform purpose-built for MedTech companies. The end-to-end solution goes beyond traditional QMS needs by integrating cross-functional teams, processes, and data throughout the entire product lifecycle so device makers can proactively overcome execution gaps, streamline compliance, and accelerate market success. Greenlight Guru’s platform is used by organizations across the globe that are replacing their disjointed, legacy tools and solutions to bring life-changing products to people faster, and with less risk. Visit our homepage to learn more.



Vascular Sciences has been conducting seminars specifically geared toward medical device design, development and testing since 1996. These seminars have been requested by companies ranging in size from start-up to fortune 100 companies, the European Patent Office and the FDA Centers for Devices and Radiological Health (CDRH). Visit their website to learn more.

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