Q: What is PMA?
A: Premarket approval (PMA) is the most stringent type of premarket submission required by U.S. Food and Drug Administration (FDA). PMA approval is based on a determination by FDA that the PMA contains sufficient valid scientific evidence to assure that the device is safe and effective for its intended use(s).
In February 2015, the FDA issued a new regulation requiring that manufacturers submit PMAs for new and existing AEDs and accessories.
Q: The HeartStart MRx is not listed as a PMA approved device on the FDA website. Is this device not FDA approved?
A: The MRx is not PMA approved. The MRx devices in the United States that were legally sold under a 510(k) clearance can continue to be used by their owners. Philips will continue to offer HeartStart MRx batteries, pads, and hands free cables, only until February 3, 2021 in the United States.
Q: Must the HeartStart MRx be removed from customer sites in the United States?
A: HeartStart MRx devices installed at customer sites may remain in service.