The US Food and Drug Administration (FDA) has updated its guidance on biocompatibility issues medical device sponsors should consider in their premarket submissions. This is the second time the agency has updated the guidance, which now includes an attachment that lists certain synthetic polymers and natural fabrics that do not need to meet biocompatibility requirements.
FDA first published the guidance in 2016 and revised it one before in 2020. The guidance outlines how sponsors can adhere to International Standard ISO 10993-1, which addresses medical device biocompatibility requirements. On 8 September, the agency again updated the final guidance to reduce unnecessary burdens on industry and itself by listing polymers and fabrics that may be exempt from biocompatibility testing and other requirements…
