U.S. FDA Releases Guidance on Expansion of Abbreviated 510(k) Program

Despite the month-long partial shut-down of the U.S. federal government, the Food and Drug Administration (FDA) managed to release a final version of its guidance on safety and performance criteria under its abbreviated review program for medical devices.

Posted to the FDA website on January 22, the guidance, “Safety and Performance Based Pathway: Guidance for Industry and Food and Drug Administration,” details an optional pathway under the agency’s Abbreviated 510(k) Program for certain, well-understood medical device types. According to the guidance, that “safety and performance-based pathway” can be used by applicants to demonstrate that their device meets requisite criteria to support claims of safety and effectiveness, while also reducing the burden required by direct comparison testing against a predicate device.

Like all guidance documents issued by the FDA, the “Safety and Performance Based Pathway” guidance is intended to reflect the agency’s current thinking on this issue and does not have the force of law.

Read the complete text of the final FDA guidance as posted to the FDA’s website.  Comments on the final guidance can be posted at www.Regulations.gov (reference Docket Number FDA-2018-D-1387).


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