Medtech Insight is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

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
UsernamePublicRestriction

AED downclassification?

This article was originally published in The Gray Sheet

Executive Summary

FDA may ask its Circulatory System Devices Panel to discuss the downclassification of automatic external defibrillators to Class II, the agency announces in the Oct. 28 Federal Register. The agency urges stakeholders to submit new safety and efficacy data on AEDs, currently designated Class III devices. A final rule downclassifying arrhythmia detectors and alarms to Class II with special controls, along with an accompanying guidance, also was issued Oct. 28. FDA announced its plans to reclassify arrhythmia detectors and alarms in December 2002, responding to petitions from AdvaMed, Quinton Instrument and Zymed Medical Instrumentation (1"The Gray Sheet" Dec. 23, 2002, p. 24)...
Advertisement

Related Content

Advertisement
UsernamePublicRestriction

Register

MT019241

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

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