2018 - Understanding the FDA’s revised medical device product guidance - Refuse to Accept Policy for 510(k)s and Acceptance and Filing Reviews for Premarket Approval Applications (PMAs)

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.
The checklists clarify the content needed in traditional, special, and abbreviated 510(k) submissions to allow FDA to conduct a substantive review, thereby enhancing the quality of received 510(k) submissions and improving overall review time.
The Acceptance and Filing Reviews for Premarket Approval Applications (PMAs) contains other critically important checklists that cover the acceptance review criteria for PMAs.
This document also addresses medical device products which include drug components. The guidance outlines new requirements direct registrants to include drug patent information as well as any exclusive marketing rights that may cover a combination product’s drug component. The FDA requires this information as a factor in determining whether applications are complete and can proceed to more in-depth reviews.
WHY SHOULD YOU ATTEND
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.
AREAS COVERED
• 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
LEARNING OBJECTIVES
• 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
• List and describe the contents application of the checklists contained in each guidance document
WHO WILL BENEFIT
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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