Best Practices to Obtain FDA Feedback Prior to 510(k) and De Novo 2019 is a webinar that covers topics such as:
- Definitions
- Applicable Statute(s) and Regulations
- How to Request a Meeting
- Recent FDA Policy and Process
- What Questions to Ask to the FDA
- How to Prepare for a Meeting Package
- Regulatory Requirements for 510(k) and De Novo
- How to Address Regulatory Questions to the FDA
- Best Practices for Interacting with FDA Reviewers
- Common Pitfalls and How to Prevent Them: Dos and Don’ts
- Conclusion
- PASS-IT Recommendations: Best Practices
Best Practices to Obtain FDA Feedback Prior to 510(k) and De Novo 2019 is intended for:
- Research and Development Departments
- Quality Assurance Departments
- Clinical Affairs Professionals
- Regulatory Affairs Departments
- Compliance Officers
- CEO’s and VP’s
- Consultants
- Documentation Departments
- Everyone interested in the topic
- Contractors / Subcontractors
