Medical Device Biocompatibility Standard Update

Key changes to U.S. FDA guidance on ISO 10993 for biocompatibility

The U.S. Food and Drug Administration recently updated its guidance on the ISO 10993 standard for biocompatibility, clarifying recommendations and requirements for medical device manufacturers.

New FDA guidance

The new FDA guidance, superseding final guidance issued by the agency in 2016, specifically covers ISO 10993-1, “Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process.” Major components of the guidance include risk management for biocompatibility evaluations; general biocompatibility testing considerations for medical device manufacturers; and test-specific considerations for cytotoxicity, sensitization, genotoxicity and other biocompatibility tests. The guidance applies to both sterile and nonsterile devices submitted for FDA premarket review.

Key updates

UL’s medical device testing engineers have analyzed the latest FDA guidance to determine key changes and updates that manufacturers should keep in mind:

• FDA has added a note under the “Risk Management for Biocompatibility Evaluation” section of the guidance, “Considering Available Information to Identify and Mitigate Risks,” indicating support of the “3 R’s” -- to reduce, refine and replace animal use in testing whenever feasible. Sponsors are also encouraged to consult with FDA when considering utilizing non-animal testing methods; FDA reviewers will determine whether such methods are appropriately equivalent.
• References to the agency’s guidance on its Breakthrough Devices Program for faster U.S. market access for qualifying devices and combination products have been added.
• Dates of issuance for referenced guidance documents have been removed.
• FDA has added URLs in place of active links for referenced guidances and other resources.

In addition, the latest FDA guidance notes that U.S. medical device market applicants may need to demonstrate compliance to additional biocompatibility standards beyond ISO 10993-1 in cases where more specific standards have been developed for certain device types.