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


Extended comment period for IVDMIA guidance

This article was originally published in The Gray Sheet

Executive Summary

Stakeholders have until Oct. 17 to submit additional comments on FDA's draft guidance on in vitro diagnostic multivariate index assays. A 30-day comment period on the agency's revised draft, which would assert FDA enforcement over certain lab-developed tests, initially closed Aug. 27, but critics said there had been insufficient time to thoroughly evaluate the guidance's implications (1"The Gray Sheet" Sept. 3, 2007, p. 7)

Related Content




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