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


CDRH’s Owen Faris: New Clinical Trials Program Will Speed Up IDE Approvals

This article was originally published in The Gray Sheet

Executive Summary

In an interview with “The Gray Sheet,” CDRH’s Acting Clinical Trials Director Owen Faris discusses the device center’s new pre-market clinical trials program aimed at speeding up approval times for investigational device exemptions and increasing the number of IDE trials in the U.S.


Related Content

FDA To Consider Patient Input For Benefit-Risk Decisions For IDEs
CDRH Touts Progress On Clinical Study Reviews
Editors' Picks: Six Themes From 2014
ODE Chief Foreman Departs Device Center; Maisel Will Fill In
FDA Abandons Proposal For Interactive, “Pre-Decisional” IDE
FDA Office Of Device Evaluation: People, Products On The Move
CDRH Focusing On New PMA Pathway, Clinical Trials Program In 2014/2015 Priorities
The Pre-Decisional IDE: FDA’s New Proposal To Help Studies Get Started Right





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