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

Mass-Spec Dx Makers Should Look To FDA's Multiplex, Multivariate Approach For Regulatory Tips

This article was originally published in The Gray Sheet

Executive Summary

As FDA develops a framework for liquid chromatography-mass spectrometry diagnostics, the agency's previously circulated policies on multiplex test instrument systems and in vitro diagnostic multivariate index assays offer hints as to what LC-MS companies can expect.


Related Content

FDA Addresses Pre-Submission Meetings In Draft Guidance
Agendia Boasts Expanded Clearance, Reimbursement For Breast Cancer Test
FDA Takes Second Stab At Multivariate Diagnostic Oversight Guidelines


Related Companies




Ask The Analyst

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

All set! This Question has been sent to 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

Add a personalized Question to your Analyst