FDA to start regulating lab-developed tests

By: AP Email
By: AP Email
The agency says its proposal is designed to make sure the tests -- which are used to diagnose various diseases and conditions -- are safe, accurate and reliable.

MGN Online

WASHINGTON (AP) -- The Food and Drug Administration says it will begin regulating laboratory-developed tests, a growing class of medical diagnostics that have never before been subject to federal oversight.

The agency says its proposal is designed to make sure the tests -- which are used to diagnose various diseases and conditions -- are safe, accurate and reliable.

While the FDA has long reviewed test kits made by manufacturers, it has never exercised authority over tests developed and used in medical laboratories. Generally these tests were simple and not widely used.

But the FDA says laboratory tests have become increasingly sophisticated, often testing for genetic information, and now compete with manufactured tests that have undergone rigorous FDA review.

Under its proposal, FDA would review higher-risk laboratory tests before they could be marketed.


The comment sections of our web set are designed for thoughtful, intelligent conversation and debate. We want to hear from the viewers but we are not obligated to post comments we feel inappropriate or violate our guidelines. Here are some of the criteria you should follow when posting comments:

Comments cannot be profane or vulgar. Children and families visit this site. We will delete comments that use profanity or cross the lines of good taste.

We will delete all comments using hate speech. Slurs, stereotypes and violent talk aren’t welcome on our web site.

Comments should not attack other readers personally.

We will delete comments we deem offensive, in bad taste, or out of bounds. We are not obligated to post comments that are rude or insensitive.

We do not edit user-submitted comments.

As a host WEAU 13 News welcomes a wide spectrum of opinions. However, we have a responsibility to all our readers to try to keep our comment section fair and decent. For that reason WEAU 13 News reserves the right to not post or to remove any comment.
powered by Disqus
WEAU 13 NEWS 1907 S. Hastings Way Eau Claire, WI 54701 By Phone: Main Number (715) 835-1313 and (715) 832-3474. Tip Line (715) 839-WEAU - (715) 839-9328 Sports Line (715) 852-1537
Copyright © 2002-2014 - Designed by Gray Digital Media - Powered by Clickability 269402231 - weau.com/a?a=269402231
Gray Television, Inc.