The #FDA has determined that the manufacturers have not demonstrated reasonable assurance of safety and effectiveness for these devices since the agency reclassified them in class III (high risk). #MedicalDevice

The #FDA has determined that the manufacturers have not demonstrated reasonable assurance of safety and effectiveness for these devices since the agency reclassified them in class III (high risk). #MedicalDevice

Source: Food and Drug Adminstration (FDA): CDRHNew - April 16, 2019 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news