In the case
of a heart ring called the Myxo ring, the manufacturers Edwards Lifesciences didn't seek clearance through the 510(k) — or any other process. Starting in 2006, the device was implanted in over a hundred people without FDA clearance, which current regulations allow. According to the agency, manufacturers with a cleared device on the market can make changes or modifications to the product without needing to submit an entire new application.
While patients didn't report any major complaints with the ring, many were troubled by the fact that a life-sustaining device could be on the market without any FDA supervision. Edwards Lifesciences maintained the ring was safe, but voluntarily recalled the device and applied for clearance.
In April 2009, after the Moxa ring had been subject to an FDA investigation and a Senate inquiry, the FDA retroactively cleared the device under a new name, saying it was safe. The agency said that Edwards Lifesciences should have sought clearance, but that they made an "honest attempt" to interpret the regulations.*
Implantable defibrillator leads are wires that connect defibrillators (devices similar to pacemakers) to the heart. Defibrillators automatically monitor and administer shocks to the heart, and a malfunction can cause the device to fire unexpectedly, or fail to fire when a patient's life depends on it. Over the past decade, the $10 billion dollar heart device industry has seen several high profile cases of malfunctioning products that posed severe risks to patients.