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Webinar on Understanding the FDA’s revised medical device product guidance

26468 E Walker Dr, Aurora, Colorado 80016-6104
26468 E Walker Dr, Aurora, Colorado 80016-6104 Aurora, CO 80016  
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Start:   Thursday, September 13, 2018  1:00 PM
End:   Thursday, September 13, 2018  2:00 PM

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Event Features: Business-Related

Neighborhood: Avenue of the Arts



OVERVIEW In early 2018, the US FDA updated its Premarket Approval (PMA) acceptance process and Refuse to Accept policy for 510(k) submissions. The primary issues that these documents seek to rectify is the number of incomplete and/or inadequate PMAs that are submitted each year and it is the intent of the FDA going forward that they will no longer accept submissions that do not meet their standard of acceptability.
This webinar will overview the important critical content of these two revised documents to include the most important checklists that are contained in the Refuse to Accept Policy guidance that provides acceptability criteria for each 510(k) – Traditional, Abbreviated, and Special.
It is critical, for those involved in the preparation of 510 (k)s and PMAs that the submissions be flawlessly prepared to prevent a refuse to accept situation. Understanding these guidance documents and applying the standards discussed will significantly mitigate the possibility of a refuse to accept letter from being received.
• FDA refuse to accept policy for 510 (k)
o Guidance overview
o Acceptance review timing
o Five preliminary questions
o Checklist review
• Acceptance and Filing Reviews for Premarket Approval Applications (PMA)s
o Guidance overview
o Grounds for refusing to accept an application
o Combination product administrative items
o Checklist
• List and describe the contents of the Refuse to accept 510 (k) and Acceptance and Filing Reviews for Premarket Approval Applications Guidance Documents
• Identify the critical components of each Guidance Document
• List and describe the five preliminary questions that are identified in the Refuse to Accept for 510 (k) document
This webinar has been designed for professionals in the medical device field and who require an update as to the provisions of the new guidance documents that have been issued. These professionals includeRegulatory affairs, Quality assurance, Clinical research, and Data management and monitoring.

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