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After Record Year for Medical Device Innovation, FDA Looks Toward Patient Safety


In 2018, the U.S. Food and Drug Administration (FDA) approved 106 novel devices, surpassing the 40-year record of 99 set in 2017 and capping eight years of steady improvement, according to remarks from FDA Commissioner Scott Gottlieb, M.D.

Going forward, the regulator intends to fight for greater patient safety when it comes to medical devices — while still nurturing device innovation in healthcare’s increasingly high-tech evolution.

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“By continuing to enhance and implement the right tools and foster an environment that lets the FDA be innovative, while prioritizing patient safety, we’ll continue to deliver on our public health mission,” Gottlieb and Jeff Shuren, M.D., director of the Center for Devices and Radiological Health, wrote in a joint statement.

Last year, the FDA focused on assuring that medical devices on the U.S. market were high-quality, safe and effective. The agency also facilitated innovation to ensure patients and providers had timely access to such devices.

The FDA took public feedback to expand its April 2018 draft of the Medical Device Safety Action Plan, which emphasized the agency’s goal of enhancing device safety and its plans to further assure the safety and effectiveness of medical devices.

Since the start of the Breakthrough Device Designation program in 2015, the FDA has granted 112 requests, and in 2018 it approved or cleared nine breakthrough devices.

Among the devices approved by the FDA last year include the smallest heart valve for newborns, the first mHealth app to treat substance abuse disorders and the first blood test to evaluate mild traumatic brain injury. The agency also approved Eyebox, which measures eye movement as an aid in the diagnosis of concussion and technologies that use artificial intelligence to detect diabetic retinopathy in adults with diabetes.

The agency has also continued using non-clinical and clinical studies to make regulatory decisions.

Due to the FDA’s efforts to strengthen clinical trial enterprise and leverage real world data, the agency has received some clinical evidence more quickly and efficiently than before.

And the agency has no plans of halting its focus on medical device innovation in 2019.

This year, the FDA plans to implement the National Evaluation System for Health Technology to more efficiently generate better evidence for device evaluation and regulatory decision making.

The agency also hopes to establish premarket pathways to enhance patient safety by increasing competition for developing safer devices.

Guidelines like the Safety and Performance Based Pathway were established in 2018 for companies to demonstrate they meet safety and performance criteria based on the performance of more modern predicate devices. And this year, the FDA plans to issues a proposed framework for the Safer Technologies Program. This program will consider how to apply breakthrough device principles and features to products intended to treat or diagnose non-life-threatening diseases or conditions.

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