Mar 24, 2021
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.
The steps and corresponding web pages given in the resource document are as follows:
The resource center concludes with the advice to utilize the FDA’s Q-Submission program for device-specific questions about biocompatibility evaluation.
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How conformity to ISO 10993 can help address FDA medical device biocompatibility requirements for US market access