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 for 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.
The key takeaways or learning's from this webinar include that:
In early 2018, the US FDA updated its Premarket Approval (PMA) acceptance process and Refuse to accept policy for initial reviews of 510(k) submissions.
The primary issues that these documents seek to rectify are 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.
Objectives of the Presentation
Why Should you Attend
- 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
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.
Who will Benefit
- 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
- Regulatory Affairs specialist
- R&D Engineers
- Medical Affairs specialist
- Clinical Affair specialist
- Quality Engineers
- Quality Professionals
- Product Development Professionals
- Senior Management
- Contractors and Subcontractors