FDA sets approval record, lays out 2019 strategy

FDA said today that it set a record for novel-device approvals in 2018, giving the nod to 106 new devices, breaking the previous record of 99. The agency also granted nine breakthrough device designation requests, for a total of 112 since the program’s inception in 2015.

Novel-device approvals in 2018 included an expanded approval of an automated insulin dosing system (Medtronic’s MiniMedG) to include children as young as age 7; the world’s smallest heart valve for newborns; the world’s first blood test (Banyan Biomarkers’ Brain Trauma Indicator) to evaluate mild traumatic brain injury (concussion); technologies using artificial intelligence to detect diabetic retinopathy in adults with diabetes (IDx’s IDxDR software) and for aiding providers in the detection of wrist fractures (Imagen Technologies’ OsteoDetect). The agency also approved the first artificial iris in the U.S. (HumanOptics’ CustomFlex) and permitted marketing of a new prescription medical device that measures eye movement as an aid in the diagnosis of concussion.

“Our success in providing patients with new treatments and diagnostics, and more options for effective health care, are not coming at the expense of the robust non-clinical and clinical science on which we rely to make our regulatory decisions,” wrote FDA Commissioner Scott Gottlieb, M.D., and Jeff Shuren, M.D., director of the Center for Devices and Radiological Health, in a statement. “For example, due in part to our efforts to strengthen the clinical trial enterprise and leverage real-world data, in some cases, we’re receiving clinical evidence more quickly and more efficiently and answering postmarket questions we would not have been able to easily address in the past.”

The FDA’ regulatory oversight came under intense public scrutiny in 2018, with the July debut of Netflix’s documentary The Bleeding Edge and, in late November, the International Consortium of Investigative Journalists’ Implant Files series. Both efforts prompted strong reactions from the agency, lukewarm ones from the industry.

The FDA will continue to move forward in 2019 with plans to implement the National Evaluation System for Health Technology (NEST) The agency said it also plans to drive competition for developing safer devices. It recently finalized guidance for an alternative 510(k) pathway initially (the “Safety and Performance-Based Pathway”), by which companies would demonstrate they meet safety and performance criteria developed by the FDA based on the performance of more modern predicate devices. The agency said it will also consider making “at least some” older devices ineligible as predicates.

Finally, in 2019, the agency expects to issue a proposed framework for the Safer Technologies Program (STeP), intended to encourage device tech that significantly improves safety as compared to current devices on the market.

“Our success in driving better safety and greater innovation depends, in part, on our ability to be innovative,” Gottlieb and Schuren wrote. “We need to be able to continually adapt our frameworks, try new approaches, and, where necessary, seek new authorities because science does not stand still.”

 

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