FDA proposes new market pathway for medical devices touting safety innovations

  • January 21, 2020

The Agency (the United States Food and Drug Administration – FDA) modeled the voluntary regulatory process after its selective Breakthrough Devices Program; however, with the goal of recognizing and rewarding innovation in areas that might not make the cut.  While the breakthrough program focuses on life-threatening diseases and unmet medical needs, the Safer Technologies Program — or “STeP” — will be designed for less-severe conditions but where previously approved products may carry serious treatment risks nonetheless.

The new program will include similar benefits, such as priority review and increased communication with FDA staff during the development process, as resources permit.  It will cover devices and device-led combination products undergoing premarket approval, de novo or 510(k) clearance reviews.  “We will do this without changing our statutory standards, data requirements or quality of review,” the FDA’s Device Center Director (CDRH), Jeff Shuren, said in a statement.  “Safety and innovation are both important priorities for the Agency.”

In a draft guidance describing the program, the FDA said it believes efforts to improve device safety will lead to improvements in overall clinical benefits, as well as fewer adverse events.  Devices that will be accepted under the program include those with “substantial safety innovations” designed to reduce known risks — including serious adverse events, device failures, use-related hazards or user errors.  This also includes devices designed to improve the safety of other medical devices or interventions.

While the FDA intends to apply many of the processes used in the breakthrough program to products expedited under STeP, should resources become strained, the Agency said it would prioritize the Breakthrough Devices Program due to its mandates under federal law.  Separately, the FDA published four (4) sets of performance criteria, built around specific device types, that manufacturers can use in lieu of a predicate device during a 510(k) submission.  They include:  conventional foley catheters; skin-based electrodes for reporting purposes; spinal plating systems; and orthopedic non-spinal metallic bone screws and washers.  “This new option for 510(k) clearance of certain well-understood device types will allow manufacturers to use objective performance criteria — established or recognized by the FDA — to demonstrate substantial equivalence of their new products or superior performance to those already legally on the market,” Shuren said.

“For example, if a manufacturer wants to market a new spinal plating system that falls within the scope of the guidance, with this new pathway, they would submit a 510(k) demonstrating that the safety and performance characteristics of their device are consistent with the new FDA-identified criteria,” he added.  “They would not need to provide a side-by-side performance assessment with a predicate device (substantial equivalence – SE).”  In some cases, previously approved, predicate devices may be older, and not contain modern technology or features, the FDA said.  “This new approach may also drive greater market competition to develop safer, more effective devices by providing the opportunity to demonstrate superior performance to the FDA-established benchmarks,” Shuren said.

REFERENCE:  Fierce BioTech; 19 SEP 2019; Conor Hale

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