3 New Device Guides for Performance-Based Pathway

FDA has posted three new guidances for device makers to use under its Safety and Performance-Based Pathway. Manufacturers have the option to use FDA-identified performance criteria to demonstrate that a device is as safe and effective as its predicate.

The guidance Spinal Plating Systems – Performance Criteria for Safety and Performance Based Pathway provides mechanical testing recommendations such as static compression bending, static torsion, and dynamic compression bending. “We recommend that you perform all testing on plate system designs that represent worst-case (e.g., most likely to loosen or fail) final design versions,” the agency says.

The next guidance, Orthopedic Non-Spinal Metallic Bone Screws and Washers - Performance Criteria for Safety and Performance Based Pathway, provides recommendations for bone screws used in orthopedic non-spinal fracture fixation, osteotomy, or small joint fusion or arthrodesis. And the guidance Magnetic Resonance (MR) Receive-only Coil – Performance Criteria for Safety and Performance Based Pathway covers MR receive-only coils that are intended for hydrogen/proton imaging. The devices are intended to have no patient contact or intended only for limited contact with intact skin (i.e., no endocavity coils).