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FDA Works to Modernize 510(k) Process, Takes Aim at Predicates, De Novo Pathways

By John Gagliardi

I began my career in the medical device and pharmaceutical industries in 1970 and have had the opportunity to see FDA’s 510(k) process evolve first-hand. From a standpoint of effectiveness and efficiency, the Premarket Notification process has certainly had its ups and downs since its origins in 1976.

Why the history lesson?

Because after 42 years, FDA announced several changes to keep up with new technologies and more sophisticated approaches to healthcare.

For medical device companies, the most important of these changes came in 4Q18 when as part of its new Medical Device Safety Action Plan, FDA announced a strengthened and more modern 510(k) pathway, used for clearance of low- to moderate-risk devices. This new pathway has a focus on predicate medical devices 10 years old or less. This framework is aimed at efficiently advancing beneficial technology to patients, while congealing FDA’s high standards for safety and efficacy. FDA is reaffirming its commitment to protecting patients by minimizing avoidable risks and advancing device technologies that are delivering growing benefits.

The Need for Modernization

In 4Q18, FDA broadcasted changes to modernize the 510(k) clearance pathway, which accounts for the majority of devices that FDA reviews every year. In 2017, the Center for Devices and Radiological Health (CDRH) cleared 3,173 devices through the 510(k) pathway, representing 82% of the total devices cleared or approved.

The Safety and Performance Based Pathway (finalized by FDA on January 22), focuses on progressively improving safety and performance of new products. The submitting company would demonstrate that a novel device meets modern performance-based criteria that have been established or recognized by FDA and reflect current technological principles in the industry. New devices that come to market under the 510(k) pathway should either account for advances in technology or demonstrate that they meet more modern safety and performance criteria. At the same time, the agency is reportedly going to pursue additional actions that will allow it to sunset outdated predicates, especially in cases where the industry has seen safer or more effective technology emerge. 

The 510(k) process allows FDA to recognize that medical devices exist across a continuum of complexity and risk, and that the scope of premarket review should reflect this risk-based approach. This is a contemporary slant to the regulation. A one-size-fits-all regulatory approach wouldn’t optimize public health outcomes, wouldn’t be efficient in advancing beneficial new technologies to patients and wouldn’t allow FDA to effectively prioritize its scientific resources.

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