Promoted by: ASQ-Dallas Food, Drug & Cosmetics SIG
Live Webinar on May 31, 2018 | 01:00 PM ET | 12:00 PM CT | 10:00 AM PT | Duration: 60 Min | By: Angela Bazigos
Are you contain necessary component or you complete all step of 510(k) submission to allow consume Center resources?
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 Centers resources, the FDA has implemented procedures to ensure that 510Ks meet a minimum threshold of acceptability; otherwise the Center will refuse to accept the submissions for substantive review.
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.
Our expert Angela Bazigos help you to understand the various cause of refusion to accept 510(k) Submissions.
Why should you attend:
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
- 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