FDA Looks to Future after ‘Record’ Year


Posted February 5, 2019

The Food and Drug Administration (FDA) is celebrating a “record year” with 106 new medical devices receiving approval in 2018. These novel devices include the first artificial iris available in the United States, the world’s smallest heart valve designed for newborns, and artificial intelligence technology to diagnose diabetic retinopathy.

The record number of approvals is the latest milestone in nearly a decade of improvement and helps demonstrate the FDA’s continuing work to “spur innovation” and improve patient safety—two missions that go hand-in-hand, according to FDA Commissioner Scott Gottlieb and Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health.

“We are equally committed to advancing safe and effective products that can address unmet medical needs to reduce the health effects from disease,” Gottlieb and Shuren said in a statement. “Both objectives are essential to meeting our public health mission, resulting in more lives saved and improved quality of life.”

As the FDA approved a record number of devices through original premarket approval (PMA), panel track supplement PMA, humanitarian device exemption, and the breakthrough devices program, it has forged ahead in its longstanding effort to modernize the premarket approval process and lower barriers to the development of innovative healthcare technology, according to the agency. These initiatives include:

  • The development of a new 510(k) pathway, known as the Safety and Performance Based Pathway, that relies on performance criteria rather than predicate devices to demonstrate safety and effectiveness.
  • The finalization of the FDA’s Breakthrough Devices Program, which provides extra support and a potentially smoother path to premarket clearance for devices receiving that designation.
  • A framework to streamline 510(k) reviews of certain lower-risk medical devices.
  • Improvements to the De Novo pathway.

The FDA intends to build on these initiatives throughout 2019 to “establish premarket pathways that foster innovations to enhance patient safety while continuing to build a more robust patient safety net in the U.S.” For example, the FDA said it plans to develop a proposed framework for a new Safer Technologies Program, which will apply the principles of the newly finalized Breakthrough Devices Program to innovative devices that don’t receive a breakthrough designation. The agency also will continue its work to implement the National Evaluation System for Health Technology, a system intended to improve postmarket surveillance through the use of real-world evidence.

“Our success in driving better safety and greater innovation depends, in part, on our ability to be innovative,” Gottlieb and Shuren said. “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.”