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

ARRHYTHMIA MONITOR DIAGNOSTIC CAPACITY IS PRIMARY DOWNCLASSIFICATION FACTOR, FDA SAYS; HIMA DRAFT PETITION PROPOSES CLASS II FOR ALL ARRHYTHMIA MONITORS

This article was originally published in The Gray Sheet

Executive Summary

Arrhythmia monitors' diagnostic capacity will be a primary consideration for FDA in deciding which types of the preamendments Class III devices are eligible for downclassification, the agency says.
UsernamePublicRestriction

Register

MT006199

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