USA – US FDA unveils online resource center for biocompatibility assessment

The US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) published its new Biocompatibility Assessment Resource Center this month to help companies navigate requirements relating to ISO 10993-1. Users of the website are advised to read the agency’s guidance document on evaluating and testing biocompatibility for medical devices, which was finalized in September 2020, in full. After this is complete, they are presented with a list of recommended steps along with the online resources to facilitate them. Rather than comprising a collection of all existing FDA resources on biocompatibility, the resource center provides a generalized procedural guide intended to be suitable for most companies…