FDA Beefs-up ISO 10993-1 Guidance Via Risk-Based Approach

FDA is incorporating a risk-based approach for analyzing biocompatibility of medical devices that come into direct or indirect contact with the body.

The FDA’s final guidance provides specifics on how to conduct a biocompatibility assessment using the International Organization for Standardization (ISO)-10993. The document updates April 2013 guidance.

When assessing new devices, the sponsor should state if the device has direct or indirect tissue contact to determine if further biocompatibility testing is needed.

Similarly, when assessing device modifications, the sponsor should clarify if a modification results in a change to direct or indirect tissue contact. If a modification would result in direct or indirect contact, a biocompatibility evaluation should be conducted.

The document addresses how to evaluate sterile and non-sterile medical devices that come into contact with the body, including:

• Use of risk assessments for biocompatibility evaluations for a proposed medical device;
• Use of ISO 10993-1 and the FDA-modified matrix to determine relevant biocompatibility endpoints for an evaluation;
• Specific considerations for testing;
• Chemical assessment recommendations; and
• Considerations for labeling devices as “free.”

The final guidance provides specific information to include in:

• Device master files for biocompatibility evaluations;
• Summary biocompatibility documentation;
• Biocompatibility evaluation flow charts;
• Biocompatibility test reports; and
• Component and device documentation examples.

The ISO 10993-1 guidance can be found here: www.fdanews.com/06-15-16-FDAGuidanceISO10993-1.pdf. — Joya Patel