Archives by Tag 'CDRH'
FDA finds Problems with Defibrillator Designs, Vows to Work with Manufacturers
By Marc J. Bern - Last updated: Monday, November 15, 2010
The U.S. Food and Drug Administration (FDA) announced today that the agency has identified problems in the manufacturing and design of external defibrillators, and will work with makers of these products to develop safer, more effective devices in its External Defibrillator Improvement Initiative. External defibrillators diagnose when a heart rhythm is abnormal or stopped and [...]
