Dueling Journal Commentaries Revisit FDA Approval of Abiomed's Impella
This article was originally published in The Gray Sheet
The pieces in JAMA Cardiology consider the merits of FDA's "515 Program Initiative" to classify preamendment devices and its application to a minimally invasive ventricular assist device.
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The approval, the first for a percutaneous hemodynamic support device, frees Abiomed's hand to market the miniature blood pump to a relatively broad patient population, analysts note.
FDA issued a final order on Jan. 28 requiring manufacturers of automated external defibrillators to submit premarket approval applications to market their products. This will immediately apply to new AEDs, but manufacturers of devices already on the market have 18 months to submit PMAs for those devices as long as they notify the agency by April 29.
FDA is proposing to require pre-market approval applications for three class III, pre-amendment device types in the cardiovascular and neurologic device spaces.