FDA Personalized Medicine Chief: Direct-To-Consumer Tests Are Not LDTs

Direct-to-consumer tests are not laboratory developed tests and, therefore, won't be offered enforcement discretion under FDA's regulatory oversight, the agency's director of personalized medicine said in a recent interview with Inside Health Policy . FDA, in recent months, has sent a number of letters to DTC test providers requesting additional information on their products. While FDA does not anticipate issuing formal guidance, one of the pioneers in advancing the agency's regulatory policy on DTC tests believes FDA has been more...