BEGIN:VCALENDAR VERSION:2.0 PRODID:icalendar-ruby CALSCALE:GREGORIAN BEGIN:VEVENT DTSTAMP:20240328T164411Z UID:e00e530f-2a5c-4db0-be97-e2b3f0ccca20 DTSTART:20210315T130000 DTEND:20210316T130000 CLASS:PRIVATE DESCRIPTION:
Overview
\n\nThe Office of D evice 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 consu me Center resources. As a means to employ more \;effectively the Cente r'\;s resources\, the FDA has implemented procedures to ensure that 5 1 0Ks \;meet a minimum threshold of acceptability\; otherwise the Center will refuse to accept the submissions for substantive review.
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\n\nWhy should you attend
\n\nThe FDA has instigated a Refuse to Accept Policy and will no longer accept 510K submissions that do not meet a minimum threshold of acceptability. B y doing so\, the Center for Devices and Radiological Health\, will be able to focus substantive review on submissions that are complete. It is expec ted that 510(K)s that are accepted under this new policy\, will be reviewe d more quickly.
\n\nIn this webinar\, you will learn what the FDA ex pects 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 a gency.
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\n\nSession Highlights
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\n\nFDA&rsquo\;s Guidance on Re fuse to Accept
\nPre-Submission Interaction
\n li>\n510(K) Refuse to Accept Policies and Procedures &ndash\; H igh LevelRefuse to Accept Principles - Detailso The 510(k) Checklist
\no FDA Review Clock
\no Notificati on of Acceptance Review Result
\nRefuse to Accept Ch ecklist - Details
\nAcceptance Review Checklist &nda sh\; Details
\nTraditional vs Non-Tra ditional 510(K)s
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\nRegulatory Personnel
\nClinical Trial Physician / Doctor
\nManager to Senior Director / VP of
\n \nRegula tory Affairs
\nQuality Assurance
\nClinical Research
\nData Management
\nData Monitoring
\nInstitutional Review Board
\nIT
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