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Company insight


Complete assurance of biocompatibility


Toxikon is a leading preclinical CRO, providing in vivo, in vitro and analytical testing services for pharmaceutical, biotechnology and medical device industries worldwide. It helps those companies gain approval for their products quickly and bring them to market successfully.


I


n 2018, the FDA launched the pilot ASCA programme as a way for there to be complete assurance in the testing being performed on medical devices to biocompatibility, basic safety and essential performance standards. This article will focus on the biocompatibility aspects of the programme. When a sponsor performs testing on an eligible device to one of the pilot programmes recognised consensus methods, FDA will accept a summary document to be submitted instead of a full study report as a part of a submission. A successful ASCA testing programme is a particularly important partnership between the device manufacturer and the test lab. After a testing laboratory has been accredited by an ASCA-recognised accreditation body, they apply to FDA for accreditation and, once approved, they can start performing ASCA selected studies. The lab may apply for accreditation to one study or all of them. The key to the pilot programme is using solid medical device and all testing is performed without deviation from FDA-recognised consensus standards.


Biocompatible standards included in ASCA programme FDA-recognised consensus standard


ISO 10993-4


ISO 10993-4 and ASTM F756 ISO 10993-5


ISO 10993-10


ISO 10993-10 and ASTM F720 ISO 10993-11


ISO 10993-11 and USP 151 ISO 10993-12


Test method(s)


Complement activation using a US-marketed ELISA kit


Direct and indirect haemolysis MEM elution cytotoxicity


Dermal irritation, intracutaneous reactivity irritation and closed patch sensitisation


Guinea pig maximisation sensitisation Acute systemic toxicity


Material-mediated pyrogenicity Sample preparation for all test types


it is also important to consider any device-specific vertical standards/FDA guidance documents as well as the 2020 FDA biocompatibility guidance. There is a significant quality backbone to the ASCA programme, which is heavily based upon ISO 17025 and all studies being conducted GLP.


“The FDA expects that manufacturer participation in this programme would potentially shave days off of the review of the biocompatibility portion.”


The following device types are ineligible to participate in the ASCA programme: absorbable and in situ polymerising devices, liquid devices, creams, gels, hydrogel devices, and devices containing nanomaterials. The biocompatibility standards being included in the pilot programme are in the table above.


Consider the standards


While the above methods are provided for the technical performance of each study,


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The quality system focus, along with only using recognised consensus standards, is designed to allow FDA to have complete confidence in staff training, metrological compliance of equipment, test device compatibility with the extraction process and test systems. As previously mentioned, if standard methods are used and no positive or unexpected results, findings or deviations occur, a summary report in lieu of a full GLP study report can be submitted with the ASCA specific declaration of


conformity. Events that could trigger a full report to be submitted include protocol deviations, but also post-extraction changes, such as rusting, particulate generation or device breakdown, or a positive observation. The impact of any of these events needs to be reported and related to clinical relevancy. In the declaration of conformity, the manufacturer will need to state where and when testing was performed, which standards were used, any issues brought up by the lab, and the resolution. The FDA expects that manufacturer participation in this programme would potentially shave days off of the review of the biocompatibility portion of a submission. As such, it will be important to use standard methods in order to get a ‘stamp of approval’. The programme will additionally help drive consistency in study performance and reporting between labs, as well as increase the direct line of communication between labs, FDA, and manufacturers. The first wave of approved labs is expected to be published in the spring of 2021. ●


https://toxikon.com Medical Device Developments / www.nsmedicaldevices.com


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