Description

This seminar presentation will provide great opportunities to get familiar with the “Best Practices” on how to obtain FDA’s constructive feedback on regulatory questions prior to preparing for and submitting a 510(k) and de novo request.  In particular, the speaker will discuss his recommended best practices including dos and don’ts. 

Based on speaker’s compiled experience over the years, he will discuss his practical, actionable recommendations to help industry understand how to best use FDA process to obtain constructive feedback on various questions during device design, development, premarket notification and de novo request.  The speaker will also discuss recent guidelines on 510(k) and de novo request in compliance with the FDA’s recent policy. 

This presentation will greatly help you how to get constructive comments from FDA reviewers prior to 510(k) submission and de novo request. 

In this presentation, the speaker will share his PASS-IT solutions based on what he has learned from his own experience while working at FDA and/or interacting with FDA reviewers, FDA management, and 510(k) staff. 

This presentation is a must for regulatory professionals working in medical device, IVD and healthcare industry.  

Areas To Be Covered:-

• Applicable Statute(s) and Regulations
• Definitions
• Recent FDA Policy and Process
• How to Request a Meeting
• How to Prepare for a Meeting Package
• What Questions to Ask to the FDA
• How to Address Regulatory Questions to the FDA
• Regulatory Requirements for 510(k) and De Novo
• Common Pitfalls and How to Prevent Them: Dos and Don’ts
• Best Practices for Interacting with FDA Reviewers
• PASS-IT Recommendations: Best Practices
• Conclusion

Who Will Benefit:-

• CEOs
• VPs
• Compliance Officers
• Attorneys
• Regulatory Affairs
• Clinical Affairs
• Quality Assurance
• R&D
• Consultants
• Contractors/Subcontractors
• Anyone Interested in the FDA Drug Review and Approval Processes