510(k) and PMA Refuse to Accept Policy 2019

  • 05 Apr 2019
  • Webinar

Description

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.

510(k) and PMA Refuse to Accept Policy 2019 covers topics such as:

  • 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

510(k) and PMA Refuse to Accept Policy 2019 is intended for:

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

Past Events

Important

Please, check "510(k) and PMA Refuse to Accept Policy" official website for possible changes, before making any traveling arrangements

Event Categories

Business: Marketing & Sales, Quality assurance
Government & Global Issues: Law & Regulations
Health & Medicine: Medical device, Pharma
Industry: Food & Beverages
Science: Engineering

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