FDA Guide Lays Out LDT Enforcement Discretion For Public Health Threats

In light of its new rule asserting regulatory authority over laboratory-developed tests, FDA will continue to exercise enforcement discretion for some tests during public health emergencies (PHEs) and for emergent public health threats, the agency says, depending on public health needs, especially if unauthorized tests are the only options available to diagnose an emerging disease. FDA issued a new draft guidance Monday (April 29) describing the factors it plans to use in assessing whether to exercise enforcement discretion for unapproved...