FDA finalizes breakthrough device guidance, plugs new safety innovation pathway

The FDA has finalized its guidance on the agency’s breakthrough device designation—and has pitched a new pathway to reward devices that innovate on safety first, before any major gains in efficacy.

The new Safer Technologies Program, or STeP, was first outlined this past April in the FDA’s Medical Device Safety Action Plan, with the goal of encouraging development of safer technologies.

STeP would, in theory, pick up what the agency’s breakthrough designation leaves behind: products that may not meet the high criteria for cutting-edge tech, but that would nonetheless offer significant benefits in safety compared to current devices or diagnostics.

"For example, consider an orthopedic device that treats a condition that is not considered to be life-threatening or irreversibly debilitating," FDA Commissioner Scott Gottlieb, M.D.,  and CDRH Director Jeffrey Shuren said in an agency statement.

"This device would not meet the Breakthrough Devices Program criteria because it is not intended to treat a life-threatening or irreversibly debilitating disease or condition; however, we will consider whether a device like this could qualify for the planned STeP program if it had an innovative safety mechanism that was intended to reduce post-surgical complications," Gottlieb and Shuren said.

"Or, consider a medical imaging device that does not meet the breakthrough criteria but significantly reduces radiation exposure in comparison to similar devices, which would be both beneficial to patients and clinicians," they added.

The FDA plans to provide additional details on STeP in the next year, including on how it would apply the same principles of the breakthrough device program to products that reduce the rates of serious adverse events or safety issues, or address common failures or user errors.

The agency’s new final guidance (PDF) follows on from an October 2017 draft document and describes how the breakthrough devices program allows companies early and more frequent discussions with FDA officials during the development process. These "sprint discussions" allow for the faster resolution of issues such as testing protocols, feedback on data development plans, and requests for clinical protocol agreements. 

Since its launch in late 2016, 110 devices have received a breakthrough designation, with eight obtaining marketing authorizations, the agency said—such as the first blood test for a concussion, or an AI-powered eye exam device for detecting diabetic retinopathy.

"If the same programmatic benefits that encourage device manufacturers to create devices to treat or diagnose a life-threatening disease could be applied to bring innovation to medical device safety for less serious conditions, the potential public safety impact could be tremendous," Gottlieb and Shuren said.

According to Cowen analyst Eric Assaraf, the new final guidance follows the firm's thesis that "the FDA will continue to take deregulatory actions for innovative devices and safety concerns will be limited to headline risk."

Other documents expected in 2019 include final guidance on an expanded, abbreviated 510(k) program; the agency's "least burdensome" provisions; and the special 510(k) program for well-defined device modifications, as well as draft guidances on cybersecurity and software, Assaraf said.

Separately, the FDA recently published a biennial report (PDF) on the risk-based regulation of digital health tools, finding more benefits than risks to patients from the use of digital products.

The report, mandated by the 21st Century Cures Act, focuses on five types of software: administrative support, including e-prescribing software; healthy lifestyle apps; certain types of electronic patient records; software that transfers, stores or displays clinical laboratory tests or other device data and results; and clinical decision support software, such as those that identify potentially harmful drug interactions.

The agency detailed the adverse event reports it received for each and listed best practices to promote safety and proper use. 

These moves come after the FDA outlined its plans to modernize its 510(k) review pathway, in the shadow of an international journalistic investigation into 10 years of agency data that linked 1.7 million injuries and 83,000 deaths to approved and cleared devices.

While defending the merits of the 510(k) process, the agency described its plan to urge manufacturers to base their device submissions on newer previously cleared predicate devices. The FDA said nearly 20% of current clearances are based on predicates that are over 10 years old.

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