FDA Urges Device Sponsors to Use ISO-10993-1 for Assessing Biocompatibility Risks

September 14, 2020

The FDA has issued final guidance for devicemakers on the use of the ISO-10993-1 international standard for assessing the biocompatibility risks of devices that come into direct or indirect contact with the human body.

The guidance applies to premarket applications, humanitarian device exceptions, investigational device applications, premarket notifications and de novo requests, and provides clarification on the use of ISO 10993-1 for risk management.

When assessing device modifications, if a change could affect parts of the device with direct or indirect contact with the body, a biocompatibility evaluation should be conducted to assess the potential impact of the change, the agency said.

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