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Dueling Journal Commentaries Revisit FDA Approval of Abiomed's Impella

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.

Is FDA’s "515 Program Initiative

" for preamendment devices leading to approvals of high-risk devices based on flawed evidence? This question is addressed by two expert commentaries posted online by JAMACardiologythis month focusing on FDA’s...

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