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About Modernizing Biocompatibility and Biological Risk Evaluation of Medical Device Materials


FDA’s Center for Devices and Radiological Health (CDRH) has identified “Modernizing biocompatibility and biological risk evaluation of device materials” as one of the CDRH’s top ten regulatory science priorities for FY2017. The regulatory science priorities serve as a guide for making strategic intramural research funding decisions to ensure that CDRH research is focused on needs that are relevant and critical to medical devices and radiation-emitting products.


To determine the safety profile of implantable or patient-contacting medical devices, it is critical to perform biocompatibility evaluation to assess the risk of adverse events. This helps us understand and address the risks posed by the potential presence of harmful chemicals or immune response triggers such as contaminants, manufacturing materials, residues and byproducts as well as device degradation byproducts.


While animal studies have historically been used to predict long-term safety and effectiveness, tests for carcinogenicity, reproductive toxicity and systemic toxicity are expensive, time consuming, use large numbers of animals and sometimes do not provide results that are easily translatable into a human risk assessment. New, less burdensome approaches that are more patient-centric and predictive of real world device performance are needed to modernize and transform biocompatibility evaluation of medical devices and their materials. The biocompatibility review of device materials could be further enhanced by developing acceptance criteria, which could include multidisciplinary evidence obtained from integrating chemical characterization, computational modeling, device surveillance and emerging risk assessment tools. Modernizing biocompatibility and biological risk evaluation will reduce healthcare costs and patients would have access to safer devices faster.


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