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Penumbra Class I Recall Again Raises Concerns About 510(k) Pathway, Device Creep

A case study of the Penumbra JET 7 class I recall in JAMA has again raised concerns about shortcomings in the US FDA’s 510(k) pathway in the medical community.

Facade at headquarters of pharmaceutical and medical device manufacturing company Penumbra on Bay Farm Island, Alameda, California

The recent class I recall of Penumbra’s JET 7 perfusion catheter highlights the need to reform the 510(k) device clearance pathway, according to researchers in the Journal of the American Medical Association and the journal’s editors. The pathway has come under criticism in recent years from researchers and news reports as medical devices have become more complex and the number of recalls has increased.

Kushal Kadakia, an MD candidate at Harvard School of Medicine who spent a short stint at the US Food and...

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