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

Randomized Controlled Trials May Be Less Burdensome, FDA Guidance Says

This article was originally published in The Gray Sheet

Executive Summary

Randomized controlled clinical trials of medical devices represent, in certain circumstances, the least burdensome route for sponsors to gain FDA approval, the agency maintains.
Advertisement

Related Content

LBITF, FDA "Concept and Principles" Draft Attests Collaborative Effort
LBITF, FDA "Concept and Principles" Draft Attests Collaborative Effort
Post-Market Studies May Be "Least Burdensome" Alternative - Industry
Post-Market Studies May Be "Least Burdensome" Alternative - Industry
FDA Open To Industry Input On Separate IVD Least Burdensome Guidance
FDA Open To Industry Input On Separate IVD Least Burdensome Guidance
PMA May Be Least Burdensome Path For Digital Mammography - Feigal
PMA May Be Least Burdensome Path For Digital Mammography - Feigal
Ventricular Tachycardia Ablation Guidance Includes Randomized Studies
Ventricular Tachycardia Ablation Guidance Includes Randomized Studies
Advertisement
UsernamePublicRestriction

Register

MT012274

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