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

Firms Must Be Proactive About Live-Case Demo Plans For IDE Devices – FDA Draft Guidance

This article was originally published in The Gray Sheet

Executive Summary

FDA has released a draft guidance on the information that a device manufacturer should submit in an investigational device exemption application or supplement if it wants the device to be part of a live case demonstration.

You may also be interested in...



Lights, Camera … Surgery? FDA Lays Out IDE Live Presentation Rules

New final guidance from the US FDA sets out the agency’s expectations for the use of live-case presentations during device clinical trials, focusing on patient protection.

Live Transmission Of TAVR Found Safe, And More From Annual SCAI Conference

Interventional cardiologists presented new data at the annual meeting of The Society for Cardiovascular Angiography and Interventions supporting the safe use of live video transmission of transcatheter aortic valve replacement cases, and results from other late-breaking clinical trials.

Novartis Targets Ten Indications For Cosentyx

The Swiss giant is hoping to get seven more approvals for its blockbuster immunology drug over the next 10 years.

Topics

UsernamePublicRestriction

Register

MT032920

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