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...
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...