Are Regulators the Root of the Problem of Serious Device Recalls?

MedPage Today September 16, 2024
Nicole Lou

— Study lays out common gaps in evidence both before and after approval

Among cardiovascular devices that were deemed unsafe enough to warrant urgent regulatory action, many had been allowed to skip rigorous premarket clinical testing in the first place, a report showed.

Researchers identified 137 Class I recalls affecting 157 unique cardiovascular devices logged by the FDA from 2013 to 2022. Of these recalled devices, just 19.1% had undergone premarket clinical testing as part of their 510(k), premarket approval (PMA), or PMA supplement applications, reported Claudia See, MD, MBA, of the University of California San Francisco, and colleagues.

And when premarket testing was done, it usually involved studies using surrogate (79.4%) and composite measures (70.6%) for their primary endpoints.

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