FDA to Lower Risk Classification of Some Medical Devices
Tuesday, May 5, 2015
Source: Smart Brief
The FDA's Center for Devices and Radiological Health said it will place a larger emphasis on postmarket information in reviewing the 21 medtech product codes that were identified as candidates for reclassification from Class III to Class II. The agency is looking to make the process of filing for premarket approval less expensive and more effective for medtech firms.