Medtech Insight is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

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

Guidance Pending To Help Clinical Labs Comply With FDA Manufacturing Regs

This article was originally published in The Gray Sheet

Executive Summary

FDA is developing guidance for clinical laboratories on how to comply with the device manufacturing quality system regulation

You may also be interested in...



AdvaMed Wants Across-The-Board Risk-Based Regulation For Diagnostics

Under an AdvaMed plan for expanding FDA regulation of diagnostic tests, tests that consist of new or unproven biomarkers on new technology platforms would likely require a pre-market approval application

Diagnostics In Brief

Pathwork tumor test: Molecular diagnostic firm receives FDA clearance July 29 for its Pathwork Tissue of Origin Test, used to determine the origin of hard-to-identify tumors. The test uses an Affymetrix microarray, cleared along with the tumor test, to measure the uncertain tumor's gene expression pattern and compare it to a panel of 15 known tumor types, including bladder, breast and colorectal. Pathwork is finalizing details to make the IVD kit available later this year; the test is already available as a service through the firm's lab. The test is the second in vitro diagnostic multivariate index assay (IVDMIA) cleared by FDA, after Agendia's MammaPrint breast cancer recurrence test

FDA Genetic Test Oversight Is On The Rise, But How Far Can It Go?

It looks increasingly likely that FDA will play a larger role in genetic test oversight, though policymakers may soon have to decide just how much more the agency can and should do

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

MT027388

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