Inconsistent Standards for FDA Approval of High-Risk Medical Devices 

A study examining the clinical studies backing the FDA approval of high-risk medical devices revealed a large variation in their number and quality, raising valid concerns about the approval process.


A medical device is an apparatus that diagnoses, cures, lessens, treats, or prevents disease by affecting the structure and function of the human body. It differs from a drug in that it achieves its intended effect without any chemical action on the body. The FDA stratifies medical devices into different categories based on the risks they pose. The high-risk category of medical devices are defined by the FDA as those that usually sustain or support life, are implanted, or present potential unreasonable risk of illness or injury. Examples of such devices include pacemakers, implanted weight-loss devices, medical imaging analyzers and cochlear implants. These devices face the toughest regulatory controls for approval from the FDA, which employs a Premarket Approval (PMA) pathway to establish the safety and effectiveness of the device.

In the study conducted, clinical studies of 28 such high-risk medical devices that received approval via the PMA pathway between 2010-2011 were tracked throughout the product lifecycle. This means studies beginning at the pre-market level required for approval, to the post-market studies that monitored the long-term outcomes of approved devices. The authors identified 286 clinical studies for the 28 devices, with 82 pre-market and 204 post-market studies, with obvious asymmetry in the number of pre-market clinical studies. The FDA used roughly one pre-market study per device to grant approval. A majority of the post-market studies too were initiated by the manufacturer (60%) and not mandated by the FDA (11.5 %). Only 6 of the 33 FDA-mandated post-market studies were reported completed. No post-market studies were uncovered for 5 of the devices, and three or fewer for 13 devices. Half the studies did not compare the device’s performance to an existing one.

What emerges from an analysis like this is the realization that there is a marked shift in the burden of proof required at the pre-market level to post-market surveillance. The risk to benefit ratio for high-risk devices are often understandably higher than others and might require an approach tailored to each specific device. While it is important to monitor the long term population based effects of high-risk medical devices, lowering the bar for their approval seems hardly the right way to go.

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