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

IVDs May Lose IDE Exemption Under BIMO Reengineering Reg Changes

This article was originally published in The Gray Sheet

Executive Summary

Sponsors of in vitro diagnostic device clinical trials would be required to obtain investigational device exemptions from FDA under a regulation change currently being considered by the agency's bioresearch monitoring (BIMO) reengineering team.

You may also be interested in...



FDA Pre-Announced BIMO Inspections Could Reduce Process Delays

The bioresearch monitoring (BIMO) reengineering team within FDA's Center for Devices and Radiological Health is considering the use of pre-announced inspections of sponsors of medical device clinical investigations.

Health And Wellness Trademark Review 1 December, 2020

Trademarks are registered and published for opposition with the US Patent and Trademark Office and are published weekly in the agency's Official Gazette.

Ipsen CEO Outlines Strategy For Long-Term Success

While analysts are struggling to look further than generic competition facing the French firm's best-seller Somatuline, new chief David Loew tells Scrip that intelligent lifecycle management and focused external deals will drive Ipsen's growth.

UsernamePublicRestriction

Register

OM013133

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

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