On Monday, November 15, 2021, the Food and Drug Administration (FDA) announced that the U.S. Department of Health and Human Services (HHS) repealed a policy established by the Trump administration that directed the FDA not to...more
The US Food and Drug Administration is working to facilitate emergency use authorization for coronavirus (COVID-19) medical devices, including diagnostic tests and respirators, while also working with the Federal Trade...more
On July 20, 2017, the Food and Drug Administration announced the clearance of “the first magnetic resonance imaging (MRI) device specifically for neonatal brain and head imaging in neonatal intensive care units (NICU)” to...more
Laboratory developed test (LDT) providers, previously exempt from U.S. Food and Drug Administration (FDA) oversight, under a new FDA proposal, must now consider if their LDTs constitute moderate-risk (Class II) or high-risk...more
Diagnostic medicine is experiencing new challenges at the USPTO and the U.S. Food and Drug Administration (FDA). Under a new FDA proposal, laboratory developed test providers, previously exempt from FDA oversight, must now...more