Over a 10-year period, 137 Class I recalls, the most serious recall type with a risk of injury or death, affected 157 unique cardiovascular devices including automated external defibrillators, intra-aortic balloon pumps and implantable cardioverter defibrillators, TCTMD reported.
In total, 71.3% of the recalled devices came to market through the FDA’s 501(K) pathway, which doesn’t require new clinical or safety data. The remaining 28.7% were approved under the premarket approval and PMA supplement process.
Steve Nissan, MD, from Cleveland Clinic told TCTMD that the 501(K) pathway has seen its share of problems over the years.
“Many of these devices are approved that way, and that means they don’t undergo rigorous testing. When that happens, mistakes get made and ultimately patients get hurt,” Dr. Nissan said.
For now, the FDA has proposed changes to the 501(k) pathway, issuing new draft guidance which, if adopted, would tighten evidence requirements as a part of the submission process.
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