510(k) and PMA Refuse to Accept Policy

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

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

Important

Please, check the official conference website for possible changes, before you make any traveling arrangements

Prices are for evaluation only.

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