5.4 Regulatory Strategy - Videos

Janice Hogan, Partner, Hogan & Hartson, LLP, on the FDA and regulatory strategy
  1. At what stage should my team meet with the FDA?
  2. Do I have any flexibility in choosing between a 510(k) versus a PMA pathway?
  3. What consideration go into picking a predicate device or devices for a 510(k) submission?
  4. Can we use clinical data from ouside the United States for FDA approval?

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.

View Video Briefs


Viagra Online In Canada