Bass, Berry & Sims attorney Danielle Sloane provided insight for an article published by G2 Intelligence related to the U.S. Food and Drug Administration’s (FDA) November 2016 announcement that it will not finalize its laboratory-developed test (LDT) guidelines by the end of the year. “Laboratories are collectively breathing a sigh of relief at the FDA’s announcement in conjunction with the knowledge that congressional action is also less likely to come to fruition under the new administration. However, the issues that drew the FDA’s concern remain, so I expect to see continued FDA vigilance in the market, particularly with respect to direct-to-consumer marketing of laboratory tests and situations in which the ordering practitioner is affiliated with the performing laboratories,” Danielle commented.

The full article, “FDA Oversight of LDTs Delayed for Consultation with New Administration, Stakeholders,” was published by G2 Intelligence on November 30, 2016, and is available online (subscription required).