The US Food and Drug Administration (FDA) has launched a new webpage aimed at providing support and advice to medical device manufacturers on the steps needed to demonstrate device biocompatibility in submissions to the Agency.
The website introduces the subject by stating: “These resource pages are intended to explain terms and concepts important for the evaluation of biocompatibility of medical devices”, while explaining that it is not intended to replace the September 2020 FDA guidance on the use of ISO 10993-1.
The four steps outlined on the webpage are:
Step 1: Biocompatibility Basics
Step 2: Evaluation Endpoints
Step 3: Test Articles
Step 4: Test Report
Each step provides links to more detailed information on subpages of the resource center.
The webpage also advises manufacturers to refer to applicable device-specific guidance documents and Class II Special Controls Documents for any relevant, device-specific biocompatibility information.
The launch of the resource center comes a few months after the Agency published a new draft guidance relating to updates to the September 2020 FDA guidance, aimed at reducing the biocompatibility regulatory burden on manufacturers whose devices are in contact with intact skin only, where the contact material is included on a list within the guidance.