CDRH Announces Intent to Initiate the Reclassification Process for Most High Risk IVDs
FOR IMMEDIATE RELEASEJanuary 31, 2024 The following is attributed to Jeff Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health (CDRH) As CDRH moves into 2024 and beyond, the Center intends to initiate the reclassification process for...