FDA Announces Record Rate of Novel Device Approvals in 2018


In the past 5 years, the administration has continually improved on the previous year's rate. More of the same should be anticipated in 2019.


In its return from the federal government shutdown on Monday, the US Food and Drug Administration (FDA) shared news that it had reached a record high of novel device approvals in 2018.

The 2018 final total of 106 devices—approved under Premarket Approval (PMA), panel track supplement PMA, de novo, Humanitarian Device Exemption (HDE), and breakthrough 510(k) pathways—topped last year’s previous high of 98 approved devices. Since 2014, the FDA has approved a new highest annual total of novel devices each year.

Among its novel approvals last year, the FDA also cleared 9 breakthrough designation devices. In a statement announcing the record rate, Commissioner Scott Gottlieb, MD, and Director of the Center for Devices and Radiological Health Jeff Shuren, MD, highlighted a series of innovative devices to receive approval under the administration’s “efficient, risk-based approach to total product life-cycle regulation.”

The highlighted novel devices shared by Gottlieb and Shuren included, among others:

  • The first blood test marketed for evaluating patients for concussions
  • The smallest mechanical heart valve approved for marketing in the world
  • The first artificial intelligence device for diabetic retinopathy detection
  • A standalone prosthetic iris for patients with a congenital condition
  • An automated insulin delivery monitoring system for pediatric diabetics

The pair praised the robust innovation in newly-approved devices, as well as the FDA’s commitment to ensuring their safety and benefit for patients.

“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,” they said in the statement. He noted the administration’s efforts to strengthen the average applicants’ clinical assessments and their providence of real-world data has led to a more efficient post-market process.

In this coming year, the FDA intends to implement the National Evaluation System for Health Technology (NEST), a program designed to nationally link and synthesize data from clinical registries, electronic medical records, and medical billing claims to improve the quality of real-world evidence available for healthcare providers and patients.

NEST, coupled with plans to establish more premarket pathways that would focus on improving national patient safety nets—such as the recently finalized Safety and Performance Based Pathway—or modernize current pathways, are anticipated to continue to optimize the regulation process.

The end result—in an era of burgeoning breakthroughs in digital health, 3D printing, and other technologies—could be a sixth straight year of record-breaking novel device approvals.

“Not only must we keep pace with this complexity and innovation, but we must also stay ahead of the new and evolving risks that can sometimes accompany novel products,” Gottlieb and Shuren said. “We must skate to where the puck will be, and, even better for patients, drive the puck to where it should be.”

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