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Bio Evaluation
Regard less of the med ical f ield you choose to inf luence through technological or any
other f orm of innovation, as long as your novel d evice will either d irectly or
ind irectly impact patients, biological evaluation introd uces regulations that help
keep humanity and other plants and animals saf e f rom harm. Due to the f act that
FDA is constantly f ind ing new ways to red uce potential harm to living organisms,
we have to be wary of their requirements f rom the early onset of the d evelopment
stages. A pragmatic biological evaluation d esign recognizes the ad herence to strict
guid elines as they have been spelled out in I SO 10993 S tand ard . Since this policy
targets scientists and other innovators spread out across the world , those of us who
are located within the bord ers of the US can ref er to the 2016 FDA Guid ance which
only has slight d if f erences when compared to the f ormer policy.
I n a nutshell, the 2016 FDA Guid ance helps innovators in the f ield of med icine to
incorporate human f actors d uring the assessment of their med ical d evice’s utility and
engineering (FDA). The consequence of ad hering to this guid eline to the letter is a
1 “When assessing new devices, the sponsor should specifically state if the device does not have
any direct or indirect tissue contact, and no further biocompatibility information would be
needed.”
2 “We also recognize that an ISO standard is a document that undergoes periodic review and is
subject to revision.”
3 “Such a process should generally begin with assessment of the device, including the material
components, the manufacturing processes, the clinical ...
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