Left to Their Own Devices: Breakdowns in United States Medical Device Premarket Review

Using examples from recent FDA regulatory proceedings, Jonas Hines and colleagues critique the medical device premarket review and identify eight weaknesses in the process that should be remedied

Summary of statutory and regulatory issues, case exemplars, and necessary corrective actions.

a<p>Although these weaknesses are susceptible to shifts in agency discretionary practices, such changes are not sufficient; for consistent and meaningful improvement, these laws and regulations must be revisited and strengthened.</p

Class III 510(k) device types not fully reviewed by the FDA, 1976–2009.

<p><i>Note</i>: if a device was later determined to have more than one indication, the review was considered complete only after all indications had been reviewed.</p

Schematic representation of medical device premarket review mechanisms.

<p><i>Note</i>: Issues listed in circles. Issue 8 does not appear in Figure 1. SE, substantially equivalent. * The 1997 FDAMA exempted most class I devices and a small number of class II devices from 510(k) requirements. € If determined to be not substantially equivalent, the sponsor may submit a PMA application. Alternatively, a sponsor may request evaluation under the <i>de novo</i> pathway (see text). Δ Post-decision scheme not illustrated.</p