FDA Safety and Performance Based Pathway Performance Criteria

Today, the U.S. Food and Drug Administration (FDA) issued four draft guidances and updated a final guidance related to the Safety and Performance Based Pathway as part of our commitment to strengthening and modernizing the 510(k) program, as described in the FDA’s Medical Device Safety Action Plan.  As a first step towards operationalizing of the Safety and Performance Based Pathway, the FDA issued four draft guidances that identify performance criteria and testing methodologies for  certain devices within four class II device types: Conventional Foley Catheters Cutaneous Electrodes for Recording Purposes Orthopedic Non-Spinal Metallic Bone Screws and Washers  Spinal Plating Systems The FDA also updated the Safety and Performance Based Pathway final guidance.

Read the Guidance Upcoming webinar on this guidance  On November 7, 2019, the FDA will host a webinar on the Safety and Performance Based Pathway guidances for industry and others interested in learning more about these guidances. Registration is not necessary. Submit comments on this draft guidance  These draft guidances will be open for public comments for 90 days at www.regulations.gov under docket numbers FDA-2019-D-1647 (Spinal Plating Systems), FDA-2019-D-1649 (Cutaneous Electrodes), FDA-2019-D-1651 (Foley Catheters) and FDA-2019-D-1652 (Orthopedic Non-Spinal Metallic Bone Screws and Washers).    Questions? If you have questions about these guidances, contact the Division of Industry and Consumer Education.