5.4 Regulatory Strategy - Videos
Janice Hogan, Partner, Hogan & Hartson, LLP, on the FDA and regulatory strategy- At what stage should my team meet with the FDA?Adobe Flash Player not installed or older than 9.0.115!
- Do I have any flexibility in choosing between a 510(k) versus a PMA pathway?Adobe Flash Player not installed or older than 9.0.115!
- What consideration go into picking a predicate device or devices for a 510(k) submission?Adobe Flash Player not installed or older than 9.0.115!
- Can we use clinical data from ouside the United States for FDA approval?Adobe Flash Player not installed or older than 9.0.115!
Video Briefs
The Stanford University Biodesign team has developed a series of video briefs that address important information about medtech regulatory processes and requirements in the U.S. The videos, which were funded by the Kauffman Foundation, feature regulatory experts Su-Mien Chong and Howard Holstein. They are intended to reinforce and expand upon the regulatory content covered in the Biodesign text. The videos present content on regulatory basics, fundamental regulatory strategies, and several short case studies on medtech companies and their interactions with the FDA.