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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.
(Ref: More details at :
http://www.fda.gov/downloads/MedicalDevices/
ScienceandResearch/UCM521503.pdf)
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