日本小児循環器学会総会・学術集会

Obtaining FDA approval for a new medical device in the USA can be a challenging task even for large corporations. For an academic clinician navigating these challenges can be overwhelming. This experience and the lessons learned from the COAST and COAST II pivotal FDA trials will be discussed. Specifically the use of Objective Performance Criteria and Severity of Illness Scores will be discussed. Also reviewed will be the lessons learned from the trial design.