Devices & Diagnostics, Policy

JAMA medical device study highlights concerns with 21st Century Cures Act

“Most high-risk medical devices are being approved on the basis of a single pivotal trial, and these trials have clear weaknesses,” said Yale University public health researcher Joseph Ross.


High-risk medical devices may not undergo the appropriate regulatory screening before and after they’re approved, according to a recent JAMA study – highlighting a conspicuous point of contention to the House-approved 21st Century Cures Act.

The Act argues that if we speed up the approval of drugs and devices, more sick patients will benefit. But critics worry that speeding through the regulatory process will allow for potentially harmful products to make their way to patients.

The JAMA study, led by Yale University public health researcher Joseph Ross, strengthens this argument. It finds a great deal of variation in the pre-market approval (PMA) pathway. High-risk devices are those that support or sustain human life, prevent illness, or can be dangerous when used in patients.

“Further reducing the premarket requirements as proposed by the 21st Century Cures Act threatens to undermine the existing incentives that ensure that high-risk medical devices have been shown to be safe and effective prior to approval, without creating incentives to ensure that evidence is generated for these devices in the postmarket period,” Ross wrote to MedCity News in an email.

Indeed, this is a real point of concern about the Food and Drug Administration’s regulatory path for such high-risk devices. Critics worry that the clinical studies leading to approval lack the adequate rigor and are prone to bias.

“Most high-risk medical devices are being approved on the basis of a single pivotal trial, and these trials have clear weaknesses,” Ross said. High-risk medical device trials tend to study 250 patients on average; the follow-up lasts for a year or less, and most have no comparator group.

Most of the arguments for reducing the pre-market clinical trial requirements are actually coupled with proposals for better post-market study, Ross said. But that just isn’t happening. It leads one to question whether passage of the current state of 21st Century Cures might allow for devicemakers to further sidestep stronger PMA trials and post-market efficacy studies.

The study examined 28 high-risk devices that were approved in 2010 and 2011. On average, each device was tested in only two clinical studies before getting the FDA stamp of approval — most just gauged the basic functionality of the device, as opposed to their longterm clinical outcomes.

It’s key, Ross said, to improve our ability to collect information on medical devices after they’ve been on the market. He cited the example of the FDA building out a new Unique Device Identifier (UDI) system — a measure that in theory could help track the safety and efficacy of a medical device. But this will only be effective if electronic health records are adapted to include UDI information so such data can be tracked accurately.

In the meantime, there’s a fear that the speeding up of drug and device approvals through the 21st Century Cures Act — or through maintaining the FDA’s status quo — will just lead to more approvals of inadequately tested devices. After all, if it’s flawed now, what might happen should pre-market approval regulations become more lax? Already, it’s very rare for devicemakers to actually complete postmarket clinical studies, Ross said — including those that are required by the FDA.

“This suggests that there is little ‘new’ information to inform regulators, patients, physicians, or the manufacturers,” Ross said. “Until we have a better way to collect information on medical devices in the postmarket period, or more stringent clinical study requirements, it is hard to see how reducing the premarket requirements will lead to more informed patient decision-making.”