FDA updates medical device biocompatibility guidance

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.

“FDA believes that these materials pose a very low biocompatibility risk because they have a long history of safe use in legally marketed medical devices that contact intact skin,” said FDA.

“The policy outlined in this Attachment describes a least burdensome approach for these devices that recommends specific material information to be included in a premarket submission in lieu of biocompatibility testing,” the agency added. “This approach also supports the principles of the ‘3Rs,’ to replace, reduce, and/or refine animal use in testing when feasible.”

FDA said the policy is based on its experience with the materials in question and relies on its Quality System Regulations and other policies to track potential biocompatibility issues with products that get to market.

The list of materials that are excluded from typical biocompatibility requirements may be used in medical devices, according to FDA, if the sponsor has provided certain assurances, such as the fact it has purchasing controls of the material’s suppliers and has investigated and reported any complaints associated with the materials. If sponsors provide such assurances, the materials would not need to be disclosed in premarket submissions and can include other processing chemicals and additives but cannot include color additives.

In total, FDA listed 24 polymers and three fabrics on the list of materials that do not need to meet typical biocompatibility requirements. The agency also encouraged stakeholders to recommend other materials that should be added to the list and said that it plans to reassess the list periodically.

“FDA recommends that external stakeholders submit comments to the docket to suggest the addition or removal of device materials or exclusion characteristics from the policy outlined in this Attachment, including a rationale,” said FDA. “FDA intends to review comments received in the docket and periodically assess whether any changes to this policy are warranted.”

The agency also recommended stakeholders include the generic chemical name, identify FDA medical device product codes, and give a rationale for why the material in question poses a low biocompatibility risk when asking regulators to add the material to its list.

Furthermore, FDA recommended that sponsors use its Q-Submission process to have early conversations about whether the materials on the list could be used in their product under circumstances beyond those identified in the guidance. RAPS.org