510(k) and PMA Refuse to Accept Policy 2019

510(k) and PMA Refuse to Accept Policy 2019 is a webinar dedicated to the important critical content of the 510(k) and PMA revised documents.

Topics

• Acceptance and Filing Reviews for Premarket Approval Applications (PMA)s
  • Grounds for refusing to accept an application
  • Guidance overview
  • Checklist
  • Combination product administrative items
• Refuse to Accept for 510(k)
  • Acceptance review timing
  • Guidance overview
  • Checklist review
  • Five preliminary questions

Who should Attend

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