On 30th August 2021, the Center for Devices and Radiological Health released 2 new draft guidance related to Premarket, 510(k). i.e., Denture Base Resins – Performance Criteria for Safety and Performance Based Pathway and Facet Screw Systems – Performance Criteria for Safety and Performance Based Pathway.
Under Denture Base Resins – Performance Criteria for Safety and Performance Based Pathway framework, submitters planning to submit a 510(k) using the Safety and Performance Based Pathway for denture base resins will have the option to use the performance criteria proposed in this draft guidance to support substantial equivalence, rather than a direct comparison of the performance of the subject device to that of a predicate device.
Devices that are the subject of this guidance are denture base resins. These devices are Class II and are regulated under 21 CFR 872.3760, Denture relining, repairing, or rebasing resin, with the product code EBI.
Under Facet Screw Systems – Performance Criteria for Safety and Performance Based Pathway framework, submitters (you) planning to submit a 510(k) using the Safety and Performance Based Pathway for facet screw systems will have the option to use the performance criteria proposed in this draft guidance to support substantial equivalence, rather than a direct comparison of the performance of the subject device to that of a predicate device.
The facet screw systems that are the subject of this guidance consist of metallic bone screws and optional washer components. These devices are unclassified and are identified with the product code MRW (system, facet screw spinal device).
Check out Denture Base Resins & Facet Screw Systems guidances for more details.
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