Medtech Insight is part of the Business Intelligence Division 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

CDRH's Expedited Access Pathway: 17 Devices And Counting

This article was originally published in The Gray Sheet

Executive Summary

A system using nerve stimulation to treat diaphragm atrophy in mechanical ventilation patients is the latest product to be granted EAP designation. FDA officials recently confirmed that 17 devices have been accepted to the expedited development pathway about a year after the program launched.

Advertisement

Related Content

US FDA Ready To Accept 510(k) Devices To Expedited Access/Breakthrough Pathway
PDUFA VII Already: Could Breakthrough Ideas Apply Outside Program?
Senate Panel Passes Breakthrough Device, Other Measures; FDA Funding Debated
FDA Hopes To Balance Upfront Time Investment With Easier Reviews In New PMA Program

Topics

Related Companies

Related Deals

Advertisement
UsernamePublicRestriction

Register

MT034783

Ask The Analyst

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

All set! This Question has been sent to 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