White Paper: Medical

The New FDA Draft Guidance for Biocompatibility of Certain Devices in Contact with Intact Skin

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In October 2020, the FDA released a new draft biocompatibility guidance document that focuses on the biological evaluation of devices in contact with intact skin. As a draft document, it is therefore open for comments and possible changes. Release of this guidance signifies another step from the FDA toward their 3R animal initiative (reduce, refine, and replace animal use in testing when feasible).

The main substance of the document is to give examples of well-known, low-risk, skin-contacting materials that can be evaluated without testing (the nice list of materials), while also pointing out certain materials that have high enough risk that still require biocompatibility testing (the naughty list). Along with the naughty and nice list, the FDA also gives considerations around supplier and process controls that must be evaluated in your submission when using this new avenue of no testing for skin contacting devices.

The guidance also gives instructions how to request a certain material to be added to the nice list or to be removed from the naughty list. The FDA intends to review these suggestions and periodically assess whether any changes to guidance are warranted. If changes are warranted, the FDA will issue an updated guidance.

This white paper describes sections of the FDA document including suggestions on how to use supplier control and quality systems to address risks associated with residuals on skin-contacting medical devices. It also highlights information that should be included in a premarket submission while following the guidance, recommendations on what should be included in the Device Master Record (DMR), and recommended labeling information to help with devices used in patient populations that may not have the ability to recognize adverse biological responses.

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