The Food and Drug Administration (FDA) and Center for Devices and Radiological Health (CDRH) have announced efforts to modernize the 510(k) clearance pathway for medical device approval. Device manufacturers more frequently use the 510(k) pathway than other pathways to market. To gain market approval under 510(k), the manufacturer demonstrates that their device is substantially equivalent to an already marketed, or predicate, device. The 510(k) pathway is faster and easier than for devices that have no predicate. Modern devices are more technologically advanced than devices from even ten years ago. Because of its reliance on existing devices, there are concerns that following the 510(k) pathway may inhibit advancements in technology.
As part of the FDA’s Medical Device Safety Action Plan, steps to modernize the 510(k) clearance pathway include:
Guiding medical device manufacturers to 1) use more modern predicate devices or 2) objective performance criteria when developing new technologies and during comparative testing
Comparing newer devices to modern concepts of benefits and risks
Considering listing devices that are older than 10 years on the CDRH website to encourage development of newer devices with technological advances
Encouraging a market-based approach by allowing choice between older and newer devices, which hopefully drives innovation
Creating a premarket review procedure that is adaptive to future technological advances
Finalizing the guidance on allowing manufacturers to rely on certain safety and performance factors in an alternate 510(k) pathway and expanding its use
Newer medical devices are increasingly complex and the gap between them and older technology has grown. Relying on the old pathway may not be conducive to innovation. The new approach to medical device approval will be called the “Safety and Performance Based Pathway”, which will become the primary pathway for devices eligible for 510(k) review. This modernized approach will enhance CDRH’s review of safety and effectiveness, improve efficiency, and increase the transparency of the review process.
- The Clinical Pathways Team
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