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Live Webinar Exploring the FDA Refuse-To-Accept (RTA) Guidance for 510(k) Submissions
Link to Website
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.
FDA’s Guidance on Refuse to Accept
510(K) Refuse to Accept Policies and Procedures – High LevelRefuse to Accept Principles - Detailso The 510(k) Checklist
o FDA Review Clock
o Notification of Acceptance Review Result
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
Institutional Review Board
Bazigos is CEO of Touchstone Technologies Inc. She has 40 years of experience in the Life Sciences & Healthcare Industries. Experience combines Quality Assurance, Regulatory Compliance, Information Technology, Project Management, Clinical Lab Science, Microbiology, Food Safety and Turnarounds.
(Contact us : 844-267-7299 | 954-947-5671
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