Medical Devices

For medical devices US-FDA recommends,

“that the following exposure information should be provided: An exposure assessment for each chemical (including any related impurities) to which the patient has direct or indirect contact. … This includes chemicals that can migrate from the surface or bulk of the device.“(citation from FDA Guidance for Industry and Food and Drug Administration Staff: Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process", dated 16/04/2016)

To fullfil this obligation, a state-of-the-art toxicological risk evaluation is needed, which includes an exposure assessment based on data from the supplier or analytical studies.
In Europe the new Medical Device Regulation 2017/745 together with the revised version of ISO 10993-1 from 2018 is setting new standard for the assessment of medical devices. The requirements have increased, but an intelligent testing strategy will also offer new options in mitigating of animal studies. As paradigm shift can be noticed, that the biological safety evaluation is now a flexible process based on a profound chemical - physical characterization of the material. The assessment of "black-box materials" with an unknown composition is no longer to be accepted.
As a result the requirements for biocompatibility assessments in USA and EU became more similar.