FDA Clarifies the Safety and Performance Based Pathway for devices eligible for Abbreviated 510(k)

In a draft Guidance Document issued in February 2019, FDA Clarifies the Safety and Performance Based Pathway for devices eligible for Abbreviated 510(k) . The updated guidance is found here: https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM604195.pdf