FDA to Certify Labs Instead of Reviewing Most Lab-Developed Tests

The FDA will soon launch a program for certifying laboratories that develop diagnostic tests, in lieu of drafting rules for the tests themselves, an official said.

The new approach, which FDA Commissioner Scott Gottlieb will describe in the next few weeks in his online blog, will be modeled after the FDA’s pilot approval process for digital health products, Sean Khozin, associate acting director of the agency’s Oncology Center of Excellence, said at the Harvard Personalized Medicine Conference Nov. 16. The Food and Drug Administration will release official guidance about the lab-developed tests (LDT) certification program in “the coming months,” Khozin ...