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 resources of the Center for Devices and Radiological Health. As a means to employ more effectively the Center's resources, the FDA has implemented procedures to ensure that 510Ks meet a minimum threshold of acceptability.
The FDA has instigated a Refuse to Accept Policy and will no longer accept 510K submissions for substantive review 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 session with expert speaker Angela Bazigos, you will learn what the FDA expects for a 510K submission. By following the principles outlined in this session, you will minimize the risk of your submission being rejected and will increase the potential for a speedy review and approval by the agency.
Who Should Attend
Ask a question at the Q&A session following the live event and get advice unique to your situation, directly from our expert speaker.
Angela Bazigos is the 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 & Public Health Services companies. Positions include Chief Compliance Officer at Morf Media, Director of QA,...
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