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FDA Releases Final Guidance Modernizing the 510(K) Pathway

Tuesday, January 22, 2019  
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FDA Releases Final Guidance Modernizing the 510(K) Pathway

The U.S. Food and Drug Administration (FDA) announced new steps today that it will take to strengthen the 510(k) regulatory pathway. The modernized pathway will expand manufacturer conformity to FDA-recognized consensus standards in the approvals process and is the next step to implement the actions described in the joint statement from FDA Commissioner Scott Gottlieb and CDRH Director Jeff Shuren from November 26.

The agency released final guidance that establishes the framework for the Safety and Performance Based Pathway. Under the pathway, manufacturers would have the option to demonstrate aspects of substantial equivalence by showing that a new device meets FDA-identified performance criteria that reflect current technological principles and the safety and performance of modern predicate devices. The guidance updates the existing pathway to ensure that the performance characteristics of new devices are evaluated against a set of objective, transparent and well-validated safety and performance metrics.

Additionally, the FDA will identify the types of devices and the applicable performance criteria for the Safety and Performance Based Pathway through future guidance. Upon publication of the first device-specific guidances, Commissioner Gottlieb explained the agency will communicate with stakeholders through a webinar to further explain how the new pathway will be implemented. The FDA intends to periodically review the device types and applicable performance criteria to ensure they remain appropriate.