Medtech Insight is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction

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

Related Content

Latest Headlines
See All
UsernamePublicRestriction

Register

MT020512

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel