New Medical Device Safety Plans Announced By FDA

Federal health regulators have released a new action plan, which is designed to help make medical devices safer, while spurring innovation at the same time. 

FDA Commissioner Scott Gottlieb issued a press release on April 17, announcing the agency’s new Medical Device Safety Action Plan (PDF).

According to Gottlieb, the plan will create a medical device patient safety net, attempt to streamline postmarketing changes, drive innovation, advance medical device cybersecurity, and take a Total Product Life Cycle approach to device safety.

“This new Action Plan outlines our vision for how the FDA can continue to enhance our programs and processes to assure the safety of medical devices,” Gottlieb said in the statement. “Our aim is to make sure that the new advances in technology that are enabling better capabilities and benefits are also harnessed to bring added assurances of safety, so that more patients can benefit from new devices and address unmet needs.”

One way the FDA hopes the new plan will help achieve that goal is by integrating the premarket and postmarket offices of the Center for Devices and Radiological Health (CDRH). This would result in the Total Product Life Cycle (TPLC) viewpoint for any medical device. Gottlieb indicates that this will help the agency’s experts optimize their ability to make decisions about the risks and benefits of medical devices.

“All medical devices have benefits and risks,” Gottlieb said. “And some of these risks are better understood once the device is more widely distributed and used under real-world conditions, in broader patient populations, and by a broader range of clinicians.”

However, the FDA has long been criticized for how much it relies on postmarket surveillance for detecting problems with both drugs and medical devices. Some say that it requires using the public as unwitting test subjects.

Some also note that the FDA is already struggling to adequately confirm the safety and efficiency of medical devices on the market today or under development. A study published in the Journal of the American Medical Association in August 2015 found that only a fraction of post-market clinical trials required by the FDA for high-risk medical devices are actually being completed.

Another analysis, published earlier in 2015 in The BMJ, warned that researchers found numerous discrepancies in data submitted to the FDA by medical device manufacturers seeking premarket approval for cardiovascular devices. Those discrepancies often included the number of participants varying in the actual study from the number reported to the FDA, substantially different results from similar FDA studies, and many of which were never peer-reviewed.

More recently, under Gottlieb, many critics have pointed to a number of steps the agency has taken which they say pointedly weakens patient protections in favor of industry profits.

In April 2017, the FDA indicated that it planned to allow some high-risk medical devices onto the market without having gone through clinical trials. And earlier this year the FDA announced it is considering plans that would allow medical device makers to just “summarize” malfunction reports instead of giving full detailed reports as currently required.