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Biocompatibility Testing: FDA Criteria (2015-06-10)
We all interact with the medical world in different ways. Sometimes we go to a dentist to repair a cavity or have a root canal. Sometimes we go to a lab to have blood tests done. In both cases, we are subject to needles and surgical drills.
But it could be more complicated. What if, heavens forbid, you have to amputate a leg or an arm and then use an artificial prostheses? What if you develop heart problems and have to wear pacemakers.
The Food and Drug Administration (FDA) says, “If a product is labeled, promoted or used in a manner that meets the following definition in section 201(h) of the Federal Food Drug & Cosmetic (FD&C) Act it will be regulated by the Food and Drug Administration (FDA) as a medical device and is subject to pre-marketing and post-marketing regulatory controls.”
Biocompatibility testing for medical devicesis mandatory but what is a device? The FDA says it is an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory, which is:
· intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or
· intended to affect the structure or any function of the body of man or other animals, and which does not achieve its primary intended purposes through chemical action within or on the body.
Biocompatibility tests are performed based on certain biocompatibility testing matrix. Biocompatibility testing laboratories around the country have the great responsibility of conducting many of these tests to ensure that medical device manufacturers have abided by the regulations.
Biocompatibility testing in California has grown in line with the overall industry’s growth nationwide. There are an increasingly number of companies in the state that perform such tests to certify them before they can be used by medical practitioners.
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