510(k) and PMA Refuse to Accept Policy

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.

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

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
• Checklist

Who Should Attend:

• Quality Departments
• Regulatory Affairs Departments
• Manufacturing Departments
• Engineering Departments
• Compliance Departments
• Marketing Departments
• Documentation Departments

Course Director: CHARLES H. PAUL ‎

Charles Paul is an instructional designer and management consultant with over 30 years experience providing training and consulting services to regulated industries. He has installed quality systems and designed and developed GMP and operational documentation and training programs for foods and beverage, pharmaceuticals, biotech, cosmetics, and consumer product OTC industries.