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 You Should 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 in the Session :
Refuse to Accept for 510(k)
– Guidance overview
– Acceptance review timing
– Five preliminary questions
– Checklist review
Acceptance and Filing Reviews for Premarket Approval Applications (PMA)s
– Guidance overview
– Grounds for refusing to accept an application
– Combination product administrative items
Who Should Attend:
- Quality Departments
- Regulatory Affairs Departments
- Manufacturing Departments
- Engineering Departments
- Compliance Departments
- Marketing Departments
- Documentation Departments