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FDA outlines safety and performance-based criteria for facet screw systems and denture base resins

Posted 30 August 2021 | By Joanne S. Eglovitch 

FDA outlines safety and performance-based criteria for facet screw systems and denture base resins

The US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) on Monday issued two draft guidances outlining the performance criteria and testing methodologies device makers can use to support 510(k) submissions for denture-based resins and facet screw systems under the agency’s safety and performance-based pathway.
 
FDA issued final guidance in September 2019 explaining the new safety and performance-based pathway, which allows device markers to seek 510(k) clearance for certain devices based on performance criteria and voluntary consensus standards rather than direct comparison testing to predicate devices. (RELATED: CDRH takes first step to operationalize new safety and performance based pathway, Regulatory Focus 19 September 2019).
 
This pathway is only for new devices that have the same indications for use and technological characteristics, and that do not raise different questions of safety and effectiveness than the predicate device.
 
Facet screw systems
 
The 11-page FDA draft guidance on facet screw systems covers metallic bone screws and optional washer components that are intended to stabilize the spine. Facet screw systems that are combination products, resorbable devices and have coatings are not eligible for this pathway.
 
FDA states that manufacturers should perform mechanical testing on finished products in accordance with the American Society for Testing and Materials (ASTM) 2193 standards. Manufacturers should also conduct sterilization testing that is aligned with the International Organization for Standardization (ISO) standards, including ISO 17665-1, ISO 11135-1 and 11137-1.
 
Biocompatibility testing should also be performed in line with CDRH’s biocompatibility  guidance to assess cytotoxity, sensitization, irritation or intracutaneous reactivity and acute systemic toxicity.
 
Denture base resins
 
FDA’s draft guidance on denture base resins covers devices intended to reline a denture surface, repair a fractured denture or form a new denture base. It applies to denture rebasing resins that are composed of methyl methacrylate.
 
For 3D printed denture resins, FDA also recommends adherence to ISO 20795-1, which covers identification of each workflow and systems, for printing parameters and for processes for leftover materials.
 
FDA also recommends adherence to ISO 20795-1 for mechanical and bench testing to assess ultimate flexural strength, flexural modules and stress intensity.
 
Products must also be assessed per the FDA’s biocompatibility guideline. In the new denture base draft guidance, FDA explained that “if the subject device is manufactured from the identical raw materials using identical manufacturing processes as a predicate device with the same type and duration of tissue contact, and any changes in geometry that are not expected to impact biological response, this is typically sufficient to establish substantially equivalent biocompatibility if documentation such as that outlined in Attachment F of the CDRH Biocompatibility Guidance is also provided.”  
 
Comments are being accepted anytime.
 
FDA draft guidance on facet screw systems
 
FDA draft guidance on denture base resins
 
FDA’s draft biocompatibility guideline
 

 

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