Biocompatibility is a complicated field and, for some, tongue-twisting term so it would serve good purpose to break it down to some degree.
Biocompatibility general means how material or materials react in relations to other host environments with which they come into contact. But the term, and assessment of its impact, become more complicated when it is tested in relations to human body. That is why one often hears the term “in vitro” testing, which is tests done outside the natural environment -usually on animals–before they are allowed to enter human body.
The issue becomes even more complicated when we speak of devices that are implanted, short term or long term, in our body. Take pacemakers, hip replacements, or prostheses.
So the question become who and how determines what is safe and what is not? The Food and Drug Administration FDA) which is mandated to approve the use of such material, relies on the International Organization for Standardization (ISO) to set the biocompatibility testing matrix. In doing so, the FDA has adopted ISO 10993 as medical device biocompatibility requirement criteria.
According to the FDA, “Biological evaluation of medical devices is performed to determine the potential toxicity resulting from contact of the component materials of the device with the body. The device materials should not, either directly or through the release of their material constituents: (i) produce adverse local or systemic effects; (ii) be carcinogenic; or (iii) produce adverse reproductive and developmental effects.” The requirements include FDA 510 biocompatibility testing for pre-market notification, approval, and examination.
Biocompatibility testing in California is as much a big issue as it is in other states in the country, and perhaps even more so given that the state has a reputation for innovation and being an incubator for startup companies of various natures. The record indicates that the number of such companies in CA is on the rise.