The FDA's Center for Devices and Radiological Health on Aug. 30 issued draft guidance on the performance criteria and testing methodologies devicemakers can use to support 510(k) submissions for facet screw systems.
Four details:
1. The FDA's safety and performance-based pathway allows devicemakers to pursue 510(k) clearance for certain devices based on performance criteria and voluntary consensus standards rather than direct comparison testing to predicate devices, according to the Regulatory Affairs Professional Society.
2. The facet screw systems draft guidance covers metallic bone screws and optional washer components designed to stabilize the spine. Facet screws that are combination products, resorbable devices and have coatings are not eligible for this pathway.
3. Devicemakers should conduct mechanical testing on finished products in accordance with American Society for Testing and Materials and sterilization testing under the International Organization for Standardization standards, the FDA said.
4. Biocompatibility testing should be performed in line with the Center for Devices and Radiological Health's biocompatibility guidance to evaluate cytotoxicity, sensitization, irritation or intracutaneous reactivity and acute systemic toxicity.
Click here for the 11-page FDA draft guidance on facet screw systems.