By Stewart Eisenhart, Emergo Group
Medical device regulators at the US Food and Drug Administration have clarified guidance on how manufacturers should utilize the ISO 10993 standard for biological evaluations of medical devices.
The updated guidance replaces guidance the agency had finalized in 2016 that emphasized biological evaluations in conjunction with risk management considerations for sterile and non-sterile medical device premarket applications, including 510(k) premarket notifications, Premarket Approvals (PMA) and De Novo requests for designation. The guidance specifically addresses ISO 10993-1, “Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process.”
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