High-risk cardiac devices are safe
Device 'supplement' applications are generally not accompanied by new clinical testing, with implications for patient safety
24-Jan-2014 -
The Food and Drug Administration (FDA) ensures that high-risk medical devices, such as implantable cardioverter-defibrillators and pacemakers, are safe and effective through its premarket approval (PMA) pathway, during which manufacturers must collect preclinical and clinical data before the ...
defibrillators
medical devices