Refuse to Accept & Additional Information Request: Avoiding Problems with Medical Device Submissions

This on-demand webinar, hosted by Greenlight Guru, focuses on navigating the FDA's Refuse to Accept (RTA) policy and handling Additional Information Requests (AIR) effectively. Using actual case studies, this session offers practical guidance to help medical device companies avoid common pitfalls in their submissions to the FDA.
Main points covered:
1. Understanding the FDA review process, including differences between administrative and substantive/scientific reviews.
2. Analyzing real examples of AIRs and RTAs from medical device submissions.
3. Providing actionable tips on designing a submission that passes administrative review.
4. Utilizing electronic tools effectively to minimize RTA determinations.
5. Developing strategies to address AIRs and RTAs if encountered.
Target Audience:
• Regulatory Affairs Professionals & Management
• Quality Professionals and Management
• Medical Device Executives
• Product Development Engineers and Management
Access the printable slides for this presentation by visiting:
www.greenlight.guru/webinar/r...