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