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# Draft Guide on Biocompatibility of Devices Contacting Skin
- URL: https://www.fdaweb.com/draft-guide-on-biocompatibility-of-devices-contacting-skin/
- Published: 2020-10-14T12:00:00.000Z
- Updated: 2026-09-14T16:32:31.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5147866

CDRH has released a [draft guidance](https://www.fda.gov/media/142959/download?ref=fdaweb.com) entitled *Select Updates for Biocompatibility of Certain Devices in Contact with Intact Skin*. The document proposes select updates to FDA’s current thinking on the type of biocompatibility information that should be provided in a premarket submission for certain devices made from common polymers and fabrics that come into direct contact or indirect contact with the human body to determine the potential for an unacceptable adverse biological response.

The guidance includes an attachment on biocompatibility that describes a least burdensome approach for certain devices that recommends specific material information to be included in a premarket submission in lieu of biocompatibility testing, which reduces animal testing. The approach is partially based on FDA’s review experience in premarket submissions with common polymers and fabrics. It also relies on certain parts of the Quality System Regulation and other postmarket controls to identify potential biocompatibility-related issues.