Researchers warn that the AvertD test may “give clinicians and patients false and potentially harmful information.”| Mad In America
How to determine if your product meets the definition of a device.| U.S. Food and Drug Administration
Use CDRH’s Customer Collaboration Portal secure website to send eSTAR and eCopy premarket submissions and track progress of 510(k) submissions online.| U.S. Food and Drug Administration
Automated External Defibrillators with information on proposed order: premarket approval for automated external defibrillator system| U.S. Food and Drug Administration