On Feb. 11, the FDA released new draft guidance, helping Class II and III orthopedic device developers discern what type of information to include in their submissions for devices using ultrahigh molecular weight polyethylene material.
Here are six insights:
1. The draft guidance will be open for comments for the next 90 days.
2. The guidance is intended for companies seeking to characterize and test orthopedic devices that use UHMWPE materials, such as conventional UHMWPE, highly cross-linked UHMWPE and highly cross-linked UHMWPE containing vitamin E.
3. The FDA guidance includes what the agency believes should be featured in a 510(k), de novo requests, premarket approval applications, humanitarian device exemptions or investigational device exemption submissions to the FDA in order to characterize the UHMWPE material.
4. The FDA says when submitting PMA, HDE or IDE in de novo, the results for these properties and their projected impact on device performance "should be thoroughly discussed and supported with available literature and a scientific rationale and incorporated into the benefit/risk analysis for the device."
5. For class II devices in terms of biocompatibility, the guidance says if the subject device has identical UHMWPE materials and manufacturing processes as a predicate device, with the same type and duration of patient contact, the company should identify the predicate device as part of its biocompatibility evaluation in place of providing specific testing.
6. The FDA advises companies against "packaging UHMWPE-containing unstable free radicals in air-permeable packaging because shelf-aging may degrade the mechanical properties of UHMWPE. The shelf life of UHMWPE that has not been exposed to ionizing radiation, or that has been irradiated but packaged in inert environment, is limited by the integrity of the packaging material."
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