Bass, Berry & Sims attorney Danielle Sloane was quoted in a Becker’s Hospital Review article about federal oversight of laboratory developed tests (LDTs).
Danielle was quoted saying, “The FDA seems to be promoting the ‘notification’ avenue. As part of the notification, the laboratory will need to report to the FDA information about each LDT, including laboratory legal name, contact email address, test name, monthly test volume, a brief narrative describing the intended…clinical use of the test and more. The FDA will use the information gathered and work with industry experts to classify LDTs .”
The article, “FDA issues guidance for laboratory developed tests,” appeared on October 8 on Beckershospitalreview.com.
To read the article, click here.