Life Sciences Co-Head Quoted in Laboratory Economics on Laboratory Developed Tests Oversight Shifting to U.S. Congress

In The News
December 22, 2016

Life sciences practice co-head Gregory Levine (Washington, D.C.) was quoted in a December Laboratory Economics article on the uncertainty of regulating laboratory developed tests (LDTs) after the U.S. Food and Drug Administration (FDA) decided not to finalize its draft guidance issued in October 2014. The article cites a Ropes & Gray alert on LDT regulatory policy by the FDA.

Mr. Levine explains that in light of the FDA announcement, it is possible that the U.S. Congress could use the next round of Medical Device User Fee Amendments to establish a new LDT scheme if consensus can be reached.