Best Practices to Obtain FDA Feedback Prior to 510(k) and De Novo 2019
06 Jun 2019
Webinar
Description
Topics
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
Who should Attend
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
Past Events
Best Practices to Obtain FDA Feedback Prior to 510(k) and De Novo 2019 - 06 Jun 2019, Webinar (84867)
Important
Please, check "Best Practices to Obtain FDA Feedback Prior to 510(k) and De Novo" official website for possible changes, before making any traveling arrangements
