Lab Group Eyes Suit Over FDA's LDT Plan; Upton Asks FDA To Help Craft Diagnostic Reg Alternative

The American Clinical Laboratory Association’s legal counselors told laboratory stakeholders Monday (May 4) that they are “ready, willing and able to litigate” against FDA over its proposed framework for laboratory-developed tests (LDTs) -- which brings such tests under the agency's medical device classification system -- soon after the House Energy and Commerce chair asked FDA to help lawmakers craft a new diagnostic regulatory framework for inclusion in the panel's 21st Century Cures bill. Chairman Fred Upton (R-MI) said at a...