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...
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Ahead of the 11 June UK spending review and its anticipated funding uplift for healthcare and life sciences, the MHRA announced an expansion of its digital expertise by creating a dedicated hub in Leeds, a renowned center of medtech excellence.
FDA moves forward with implementing previous draft guidance and will consolidate forms, but the agency estimates limited impact in the total reporting burden.
The US FDA's new draft guidance details the responsibilities of new owners of 510(k) clearances, including making timely updates device listings in FURLS and GUDID to maintain accurate information for safety alerts and recalls. Comments on the draft are accepted until 4 August.
