NSA · Class III — High Risk (PMA approval required, life-sustaining) · Cardiovascular · 21 CFR 870.5310
Classification
FDA Product Code
NSA
Device class
Class III — High Risk (PMA approval required, life-sustaining)
Regulation
21 CFR 870.5310
Review panel
CV
Medical specialty
Cardiovascular
Submission type
2
GMP exempt
N
Life sustaining
Y
Implant
N
Third-party review
N
Definition
Automated external defibrillators are devices that use external pad-type electrodes to sense, detect, classify and treat (with an electrical shock) ventricular fibrillation. These devices are intended to be used on suspected victims of sudden cardiac arrest. A person in cardiac arrest is unresponsive and is not breathing normally. The device can be sold over-the-counter without a prescription. The device is to be used on adults and children who are either > 8 years old or > 55 lbs.