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)
Charles H. Paul is the President of C. H. Paul Consulting, Inc. - a regulatory, Lean Manufacturing, training, and technical documentation consulting firm. Charles is a management consultant, instructional designer, and regulatory consultant and has led C. H. Paul Consulting, Inc. since its inception over 25 years ago. He regularly consults with Fortune 500 pharmaceutical, medical device, and biotechnology firms assisting them in achieving human resource, regulatory, and operational excellence. He is a regular presenter of webinars and on-site seminars in a variety of related subjects from documentation development to establishing compliant preventive maintenance systems. The firm works globally completing projects throughout the EU, UK, South America, and Asia.
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.
The key takeaways or learnings 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.
- 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
- 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
- Regulatory Affairs Specialist
- R&D Engineers
- Medical Affairs Specialist
- Clinical Affair Specialist
- Quality Engineers
- Quality Professionals
- Product Development Professionals
- Senior Management
- Contractors and Subcontractors
Why 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 refusal to accept the situation. Understanding these guidance documents and applying the standards discussed will significantly mitigate the possibility of a refusal to accept the letter from being received.