FDA releases performance criteria guidance for fracture fixation plates
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The FDA released guidance on performance criteria for orthopedic fracture fixation plates intended for osteosynthesis in support of the safety and performancebased pathway.
In the document, the FDA recommends submission of a static four-point bending test the worst-case bone plates for each anatomic region are selected for mechanical testing. A minimum of five samples should be tested for each worst-case plate being evaluated, according to the FDA. The document noted either all samples should meet or exceed the acceptance criteria listed by the FDA or the average of all samples should meet or exceed the acceptance criteria and the standard deviation should be 10% or less of the calculated averages to be considered a successful result.
The FDA also recommends submission of sterilization and reprocessing validation, which should demonstrate the cleanliness and sterility of the device and device-specific instruments. he document noted that all device and device-specific instruments should meet biocompatibility endpoints and be determined to have an acceptable biological response. The FDA noted the biocompatibility evaluation of any biocompatibility test samples with an adverse biological response should explain why the level of toxicity is acceptable and some comparison testing against a legally marketed predicate may be necessary to support the rationale.
Reference:
- Orthopedic fracture fixation plates – performance criteria for safety and performance based pathway. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/orthopedic-fracture-fixation-plates-performance-criteria-safety-and-performance-based-pathway?utm_medium=email&utm_source=govdelivery. Published April 11, 2022. Accessed April 12, 2022.
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