Exploring the FDA Refuse-To-Accept (RTA) Guidance for 510(k) Submissions

01:00 PM ET | 10:00 AM PT | 12:00 PM CT Duration 90 Minutes

Webinar Includes : All the training handouts , certificate ,Q/A and 90 mins Live Webinar

"Hear By Angela Bazigos who recently quoted in Wall Street Journal for using training to bring regulatory compliance to the Boardroom"

Focus substantive review on submissions that are complete


The Office of Device Evaluation (ODE) receives approximately 6500 Premarket Notification 
(5100) submissions every year. Many of these submissions are incomplete or grossly 
inadequate, as they fail to contain the components necessary to allow substantive review of 
the submission and inappropriately consume Center resources. As a means to employ more 
effectively the Center's resources, the FDA has implemented procedures to ensure that 5 10Ks 
meet a minimum threshold of acceptability; otherwise the Center will refuse to accept the submissions for substantive review.

Why should you attend

The FDA has instigated a Refuse to Accept Policy and will no longer accept 510K submissions that do not meet a minimum threshold of acceptability. By doing so, the Center for Devices and Radiological Health, will be able to focus substantive review on submissions that are complete. It is expected that 510(K)s that are accepted under this new policy, will be reviewed more quickly. 

In this webinar, you will learn what the FDA expects for a 510K submission. By following the principles outlined in this webinar, you will minimize the risk of your submission being rejected and you will increase the potential for a speedy review and approval by the agency.

Areas Covered

•           FDA’s Guidance on Refuse to Accept

•           Pre-Submission Interaction

•           510(K) Refuse to Accept Policies and Procedures – High Level

             •     The 510(k) Checklist

             •     FDA Review Clock

             •     Notification of Acceptance Review Result

•           Refuse to Accept Principles - Details

•           Refuse to Accept Checklist - Details

•           Acceptance Review Checklist – Details

•           Traditional vs Non-Traditional 510(K)s

Who will Benefit

•           Clinical Trial Physician / Doctor
•           Manager to Senior Director / VP of
•           Regulatory Affairs
•           Quality Assurance
•           Clinical Research
•           Data Management
•           Data Monitoring
•           Institutional Review Board 
•           IT

Industries who can attend

This 90-minute online course is intended for professionals in the Pharmaceutical, Clinical Data Management SaaS companies, and medical device companies . Although not presently stated in the draft , the same guide could be used by FDA Regulated Industries personnel.

Speaker Profile

Angela Bazigos

Angela Bazigos.CEO of Touchstone Technologies Inc. She has 40 years of experience in the Life Sciences & Healthcare Industries. Experience combines Quality Assurance, Regulatory Compliance, Business Administration, Information Technology, Project Management, Clinical Lab Science, Microbiology, Food Safety, Turnarounds and Business Development. Past employers / clients include Roche, Novartis, Genentech & PriceWaterhouseCoopers. Positions include Chief Compliance Officer at Morf Media. Co-authored & prototyped 21 CFR 11 guidance with FDA.  Co-authored Computerized Systems in Clinical Research w/ FDA. Patent on speeding up software compliance. Recently quoted in Wall Street Journal for using training to bring regulatory compliance to the Boardroom. National Trainer for Society of Quality Assurance. Comments / collaborates with FDA on new guidance documents. Former President of Pacific Regional Chapter of Society of Quality Assurance. Stanford’s Who’s Who for Life Sciences.

Back to Top