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News: CDRH instigates operationalizing New Safety and Performance Based Pathway

The Food and Drug Administration's Center for Devices and Radiological Health initiates the first step to operationalize New Safety and Performance Based Pathway and has issued performance criteria and testing methodologies in four draft guidance documents for the devices that are within four class II device types.

The CDRH also released final guidance that updates the new pathway and further clarifies the information using Safety and Performance Based Pathway that the FDA will review in 510(k). The three types of guidance that the FDA allows includes Traditional, Special, and Abbreviated.