FDA Official Gives Policy Update On Lab-Developed Tests
Executive Summary
Most laboratory-developed tests have no regulatory predicates, said FDA's Elizabeth Mansfield, hinting that many may require pre-market submissions that go beyond FDA's 510(k) review standards once the agency initiates plans for active oversight of the category.
You may also be interested in...
FDA's Seyfert-Margolis On Companion Diagnostics Guidance
Industry is anxiously awaiting guidance from FDA on the development of companion diagnostics for drugs that will inform efforts to move towards personalized medicine.
White House To Deliver 25 Million Face Masks To Low-Income Americans
The White House will be spending $86m to provide tens of millions of coronavirus masks to poorer American households.