FDA’s Response to COVID-19
Fundamentals of Obtaining Emergency Use Authorizations

An FDAnews FREE Webinar • Sponsored by ComplianceQuest
Wednesday, Jan. 27, 2021 • 1:30 p.m. - 2:15 p.m. EST

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 free webinar is your EUA roadmap.

Using ventilators and ventilator accessories as examples, Judith Meritz, a partner at Meritz & Muenz LLP 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. She’ll make sure you understand what the FDA looks for in the crucial risk-benefit section, so you can obtain an EUA for your device.

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.

Webinar Takeaways:

  • What an emergency use authorization means
  • The scope of an EUA
  • How the EUA’s criteria for safety, performance and labeling differs from the FDA’s regular medical device clearance and approval process
  • The FDA’s thought process — and concerns raised — in recent EUA submissions

This is your opportunity to obtain an EUA to get your device to market. Don’t miss this free webinar. Join us by registering today.


Who Will Benefit

  • Regulatory professionals
  • Engineers
  • Regulatory counsel
  • Product registration and development staff
  • Vice presidents
  • Heads of regulatory
  • Regulatory staff
  • Quality staff
  • Legal staff
  • Marketing staff
  • Engineering staff

Sign Up for FREE Below

Meet Your Presenter

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Judith Meritz

Partner
Meritz & Muenz LLP

Judith Meritz, a Partner at Meritz & Muenz LLP, has more than 30 years of experience representing pharmaceutical and medical device companies. She specializes in strategic planning and compliance mediation concerning the FDA and other international regulatory agencies. Ms. Meritz has held key regulatory and legal positions for companies including Medtronic, Covidien, Henry Schein and the American Red Cross and she chaired the medical device practice at two Washington, D.C. law firms. She has been a key player in interactions with the FDA, drafted inspection responses to numerous FDA 483s and warning letters and led companies to achieve successful outcomes and avoid further enforcement actions. Ms. Meritz taught at the FDA CDRH college on inspection readiness, adverse events and acceptable corrective actions. Recently, she assisted several medical device companies with their submissions for EUA ventilators and ventilator accessories.