Abstract
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.
Highlights
Medical devices encompass nearly every medical product that does not achieve its intended purpose through chemical action, from the simple to the complex (MRI machines), and from the safe to the risky [1,2]
N We provide a background on medical device premarket review and identify eight addressable weaknesses in the process
The agency permitted transcranial magnetic stimulation (TMS) to be reviewed under the 510(k) process with electroconvulsive therapy (ECT) as the predicate device, even though ECT involves the administration of electrical currents to induce a generalized seizure
Summary
Medical devices encompass nearly every medical product that does not achieve its intended purpose through chemical action, from the simple (tongue blades) to the complex (MRI machines), and from the safe (stethoscopes) to the risky (artificial hearts) [1,2]. The Center for Devices and Radiological Health (CDRH) at the Food and Drug Administration (FDA) is charged with ensuring the safety and effectiveness of medical devices. Amend 21 USC 1 360c to require treatment devices to meet the same standard as drugs Repeal 21 USC 1 360c(i)(1)(A)(ii) to prohibit such comparisons Repeal 21 USC 1 360c(f)(2) Complete classification of such devices, requiring PMA applications for those retained in class III. Is the predicate dev ice a class III preamendments dev ice or SE to such a dev ice?
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