Getting your device to market is easier now that the FDA opened the Emergency Use Authorization (EUA) door due to the COVID-19 pandemic. But even the most-needed device won’t get an EUA if your submission is lacking. This webinar is your EUA roadmap.
Using ventilators and ventilator accessories as examples, Judith Meritz who has more than 30 years of experience representing pharmaceutical and medical device companies, will outline the key information you must include in your submission. You’ll learn what the FDA looks for in the crucial risk-benefit section.
Ms. Meritz will emphasize the specific requirements in the FDA’s guidance and interactive review template you must understand — and conform to — to be granted an EUA.
- What an emergency use authorization mans
- The scope of an EUA
- How the EUA’s criteria for safety, performance and labeling differs from the FDA’s regulatory medical device clearance and approval process
- The FDA’s thought process – and concerns raised – in recent EUA submissions