The FDA Will Overhaul Its Medical Device Approval Process Following Scathing Report

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The U.S. Food and Drug Administration (FDA) will update its review process for the approval of medical devices in the wake of a report that showed more than 80,000 injuries have been associated with medical devices for pain management since 2008.

Before the Thanksgiving holiday, the FDA said it will establish new goals regarding device safety that will ensure the regulatory agency is “consistently first” to identify and act upon safety signals related to medical devices. In its announcement, the FDA said it regulates more than 190,000 different devices manufactured by more than 18,000 companies. On average, the FDA said it approved approximately 12 new or modified devices every day. The agency noted that it attempts to carefully evaluate the safety of a device before approval, particularly as it relates to the 510(k) process, which is a premarket submission made to the FDA required to demonstrate that the device to be marketed is “at least as safe and effective” as a legally marketed device already on the market. The FDA said when it comes to approving a medical device it takes into consideration whether the benefits of the devices outweigh their risks to patients.

“Unfortunately, the FDA cannot always know the full extent of the benefits and risks of a device before it reaches the market. Even reasonably-sized premarket trials cannot be expected to reveal everything that could eventually become known about a novel medical device once it’s more widely distributed and used under real-world conditions, in broader patient populations, and by a broader range of clinicians,” FDA Commissioner Scott Gottlieb and Jeff Shuren, director of the Center for Devices and Radiological Health, said in a joint statement.

A recent investigation conducted by the Associated Press showed that some devices, particularly those aimed at treating patients with spinal-cord nerve-related pain, cause harm to as many, if not more, patients than they help.  The investigation showed that the devices caused shocks or burns to many patients and left them worse off than before. The AP noted that there have been at least 500 deaths associated with spinal implants, but the report said the data is not specific enough to point to the device being at fault, or the surgery itself.

While spinal-cord devices were highlighted in the report, the Associated Press noted that metal hip replacements and insulin pumps have actually logged more injury reports. According to the report, “across all types of medical devices, more than 1.7 million injuries and nearly 83,000 deaths were reported to the FDA over the last decade.”

The investigation also pointed to the FDA’s approval process for medical devices, particularly the expedited process that are related to the 510(k) process, which can allow for new devices to compare themselves to marketed products that are quite old. The AP said the expedited process can put people at risk, and then noted that the FDA typically “responds slowly when it comes to forcing companies to correct sometimes life-threatening products.”

In its announcement on its new goals for improving the regulatory process for medical devices, the FDA said it will include a “vigilant post-market surveillance system” for the “quick identification and evaluation of new or increased safety concerns.”

“Robust oversight of safety also requires, timely public communication about safety issues and effective interventions to address concerns. The FDA also must foster innovation that spurs the development of safer, more effective technologies and assures timely patient access,” the FDA said.

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