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# 3 New Device Guides for Performance-Based Pathway
- URL: https://www.fdaweb.com/3-new-device-guides-for-performance-based-pathway/
- Published: 2020-12-11T12:00:00.000Z
- Updated: 2026-09-14T16:39:57.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5148288

FDA has posted three new guidances for device makers to use under its [Safety and Performance-Based Pathway](https://www.fda.gov/regulatory-information/search-fda-guidance-documents/safety-and-performance-based-pathway?ref=fdaweb.com). 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*](https://www.fda.gov/media/130867/download?ref=fdaweb.com) 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*](https://www.fda.gov/regulatory-information/search-fda-guidance-documents/orthopedic-non-spinal-metallic-bone-screws-and-washers-performance-criteria-safety-and-performance?ref=fdaweb.com), 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*](https://www.fda.gov/media/133250/download?ref=fdaweb.com)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).