In a press release issued on November 26, 2018, the U.S. Food and Drug Administration (FDA) announced more details regarding an initiative to improve the 510(k) process. The modernization plan was previously announced as part of FDA’s Medical Device Safety Action Plan: Protecting Patients, Promoting Public Health released in April this year. FDA proposes two significant changes to the 510(k) process: expand the abbreviated 510(k) pathway and limit the use of predicates greater than 10 years old to establish substantial equivalence.
Abbreviated 510(k): Safety and Performance Based Pathway
First, FDA is working on finalizing a new guidance that would expand the use of the Abbreviated 510(k) pathway to allow manufacturers of certain well-understood device types to rely on objective safety and performance criteria to demonstrate substantial equivalence. This would serve as an alternative pathway that could be more efficient and proliferate modern criteria as the basis for the predicates used to support new products. In a statement, Scott Gottlieb (FDA commissioner) and Jeff Shuren (director of the Center for Devices and Radiological Health) stated: “We are planning to rename this new approach the ‘Safety and Performance Based Pathway’ to reflect its focus on advancing improved safety and performance of new products.” Under this approach, this means that device manufacturers could submit a new device and the FDA could find it to be as safe and effective as a predicate by directly comparing certain established performance characteristics. For devices eligible under this new pathway, it could mean the end of expensive mechanical testing or intensive data and literature searches in order to provide FDA with a direct comparison between two devices to establish substantial equivalence.
Limiting device predicates more than 10 years old
Second, FDA is considering limiting the use of predicates older than 10 years to further ensure the technology of medical devices continues to innovate and advance. In a statement released last week, FDA stated that “newer devices should be compared to the benefits and risks of more modern technology; that is why we’re looking at ways to promote the use of more recent predicates.” To be clear, the FDA is not stating that predicates older than 10 years old are unsafe, instead the agency is using this as an additional pressure point on device product developers to continuously improve on the safety and performance features of new medical devices. Also, this ensures new devices entering the market reflect modern technology and that consumers(doctors and patients) have more choices. Industry representatives have cautioned FDA that the use of older predicates is a valuable tool for device manufacturers and that just because the technology is ‘older’ the clinical and scientific information should not be considered invalid.
Overall, FDA hopes to encourage medical device manufacturers to innovate and meet the needs of patients with advancements in technology, safety, and efficacy with the implementation of these coming changes. As a medical device manufacturer, it is important to keep these upcoming changes in mind during new product and regulatory strategy development discussions. The medical device advisors at Pearl Pathways will continue to inform you of these changes and develop regulatory strategies that stay ahead of the changing regulatory landscape. Learn more about our services for medical device developers.