Over-The-Counter Defibrillator, AED Adverse Events To Be Gauged By Panel
This article was originally published in The Gray Sheet
Executive Summary
FDA panel recommendations at a July 29 meeting to consider an OTC indication for an automated external defibrillator will affect only the product under review. Manufacturers of other approved systems will have to file data separately with CDRH to earn over-the-counter status, according to the agency