Biocompatibility tests are an important part of the medical profession and the public health arena in general. Medical device testinghas received more attention, in great part because the Food and Drug Administration (FDA) has made it mandatory.

The reason the FDA has made biocompatibility testing for medical devices mandatory is that these devices come into contact with our body, or are implanted in us. How they are made and how they might interact with our system could have life and death consequences.

That is why the FDA relies on ISO 10993 testing to ensure testing of medical devices are performed based on certain criteria. Those criteria are enumerated in biocompatibility testing matrixcharts that the FDA and iso 10993 biocompatibility stipulate.

The law stipulates that any new medical device should go through FDA 510 biocompatibility testing before it can be marketed commercially.

The FDA has tried to eliminate any margin of error by even specifically defining what a medical devices is, saying a device is as 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.

Given the importance of biocompatibility testing for the FDA, biocompatibility testing laboratoriesand companies around the nation, such as Biocomptesting, play an important role.

The California-based Biocomptesting (http://www.biocomptesting.com) takes pride in having made biocompatibility testing for medical devices its only bread and butter. To do the best they can, its staff ensure that they are always equipped with the latest information in their field of expertise.