Coming Soon to a Laboratory Near You? FDA’s Proposed Framework for Laboratory Developed TestsHouston Medical Times October 2014
James Boiani, Senior Counsel in the Health Care and Life Sciences practice, in the firm's Washington, DC, office, authored an article titled “Coming Soon to a Laboratory Near You? FDA’s Proposed Framework for Laboratory Developed Tests” published by the Houston Medical Times.
Following is an excerpt:
On July 31, 2014, the U.S. Food and Drug Administration ("FDA”) announced plans to regulate laboratory developed tests (“LDTs”). LDTs are an integral part of healthcare today, serving as diagnostic tools for many serious diseases and genetic conditions, so it’s incumbent on everyone who is a physician, laboratorian, diagnostics developer, or future patient (which is all of us) to understand the proposed plan so we can consider its impact.