Grapefruit USA Inc (GPFT)

[BuyOnDips]

Additionally, the researchers discovered, 12% of the recalled devices that were approved under the 510(k) process were originally marketed for "risky or life-sustaining Class III (defined as implantable or life-sustaining) indications, which are required by law to undergo a full PMA regulatory review."

These 510(k) approved devices that were recalled "were used by tens of millions of patients, exposing them to potential harm and adding substantial costs to medical care," the authors wrote.

For example, the average cost for the FDA to review a 510(k) submission "was estimated at $18,200, while a PMA submission cost the agency $870,000 to review," they wrote.

Of these recalls, the largest group were for cardiovascular use and 35 – involving 31 separate devices – and most were automated external defibrillators (AEDs) approved for resuscitation of patients in cardiac arrest. About one in five of the one million AEDs in circulation have been recalled, "and hundreds of people died due to AED malfunction," the researchers wrote. Of these 35, 23 were cleared through the 510(k) process.

The second largest high-risk recall category involved 27 general hospital devices, such as insulin pumps, intravenous infusion devices and patient lifts. Of these, 20 (74%) were cleared through the 510(k) process.

The third largest high-risk recall category involved devices used in anesthesia, including mechanical ventilators. All were cleared by the 510(k) process or were exempt.