The FDA’s proposed regulatory framework is based on a test’s level of risk to the patient.
The FDA has issued two documents: one describing the proposed regulatory framework and the other focusing on the notification process. Comments on each may be submitted by February 2, 2015 (visit
The packed ballroom looked like a plenary session at any big medical research meeting. But on the dais were representatives of the Food and Drug Administration (FDA), the subject was the Agency’s proposed regulation of laboratory-developed tests, and the attendees who lined up to ask questions for...