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About Safety of
Materials Used in Medical Devices
 Materials
used in today’s medical devices vary as widely as the
devices themselves -whether the material is metal,
plastic, silicone, an animal-derived product or some
combination of these. Because, in the case of
implantable or insertable devices, these materials come
into contact with tissue or other parts of the body for
sometimes extended periods of time, agencies like US FDA
carry out a careful evaluation during their premarket
review to determine if there is a potential adverse
biological response resulting from contact of the
device’s component materials with the body and whether
the associated risks are unacceptable.
Specifically, they review information about the
materials used in the composition of the device and
require companies to include a biocompatibility
evaluation or risk analysis, as well as clinical
studies, when appropriate. These steps help to address
any risks that may be posed by, for example, the
potential presence of harmful chemicals or materials
that might trigger allergic or other adverse reactions
in some individuals. While such testing generally has
been a reliable predictor of a material’s safety, they
also recognize the importance of advancing the science
they rely on to evaluate device materials and patient
risk factors both before and after
devices enter the market to assure that it optimally
reduces risks to patients and maximize benefits.
Understanding of medical technologies evolves over time.
With increasing knowledge about long-term effects of
materials and as materials science advances and new
innovations become a reality, it’s imperative regulation
of devices evolves along with the advances to ensure
patients are protected.
Medical device manufacturers typically assess the
biocompatibility of a material by determining how the
human body may respond to the material they plan to use
in their device. Manufacturers have to perform an
evaluation of their device to determine if there is a
potential adverse biological response resulting from
contact of the device's materials with the body and
whether the associated risks are acceptable. This
risk-based approach typically includes an assessment of
the device, including the material components, the
manufacturing processes, the clinical use of the device
including the intended anatomical location, and the
frequency and duration of exposure. Information to
support the biocompatibility of the device is then
provided to the FDA based upon such evaluation. The
FDA’s biocompatibility guidance provides recommendations
on the information that should be provided.
(
https://www.fda.gov/news-events/press-announcements/statement-fda-commissioner-scott-gottliebmd-and-jeff-shuren-md-director-center-devices-and-3
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