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FDA Launches Online Center for Biocompatibility Testing

2021-11-26
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Recently, the FDA launched the Medical Device Biocompatibility Evaluation Resource Center, an online system designed to help users better understand and complete the biocompatibility evaluation of medical devices. This system is not intended to replace the international standard ISO 10993-1 “Biological evaluation of medical devices-Part 1: Evaluation and testing within a risk management process,”, but is based on the standard and the official guide FDA’s Biocompatibility Guidance on Use of ISO 10993- 1. On-line a visualized online guidance system.

The FDA recommends that users read the official guidelines for biocompatibility assessment, ISO 10993-1, guidelines for specific devices, and class II device classification control documents, and then follow the steps below to complete the biocompatibility assessment:

Step 1: Understand the basic elements of device biocompatibility

When is biocompatibility information needed? FDA conducts biocompatibility evaluation or evaluation of products. How does FDA conduct biocompatibility evaluation of products or evaluate biocompatibility points that FDA is concerned about? Biocompatibility glossary

Step 2: Determine the endpoint of the biocompatibility assessment

Endpoints are established according to device classification: surface contact devices, external substance exchange devices, and implanted devices. End points are established according to the continuous contact time: limited contact (within 24h), long-term contact (24h~30d), permanent contact (greater than 30d)

Step 3: Analyze the biocompatibility test literature

Record and analyze the declared devices and biocompatibility test literature for comparison, and also need to compare with the devices already on the market.

Comparative analysis of components, components and ingredients Comparative analysis of the entire device

Step 4: Write a test report for biocompatibility evaluation

The evaluation test report should contain the following content:

The contents of all test reports are prepared to be used for comparison. The test literature test parameters and acceptance criteria results analysis conclusions

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