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

IVD PRINCIPAL INVESTIGATORS MUST SIGN OFF ON CLINICAL STUDY DATA

This article was originally published in The Gray Sheet

Executive Summary

IVD PRINCIPAL INVESTIGATORS MUST SIGN OFF ON CLINICAL STUDY DATA used in support of 510(k)s and premarket approval applications for in vitro diagnostic devices, FDA says in a draft "points to consider" document presented Sept. 23 to a joint meeting of the Clinical Chemistry and Toxicology Devices Panel and the Microbiology Devices Panel. The document refers to the procedure as "similar to the requirement of peer-reviewed medical journals."
Advertisement
Advertisement
UsernamePublicRestriction

Register

MT002886

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