Biocompatibility Assessment Medical Devices Materials

Basics of Biocompatibility: Information Needed for …

https://www.fda.gov/medical-devices/biocompatibility-assessment-resource-center/basics-biocompatibility-information-needed-assessment-fda

The FDA assesses the biocompatibility of the whole device and not just the component materials. Source: “This guidance considers the assessment of biocompatibility to be an evaluation of the ...

Medical Device Material Safety Summaries | FDA

https://www.fda.gov/medical-devices/science-and-research-medical-devices/medical-device-material-safety-summaries

The reports focus on answering five key questions about local and systemic response to specific materials commonly used in medical devices. ... Biocompatibility …

Biocompatibility Assessment Resource Center | FDA

https://www.fda.gov/medical-devices/premarket-submissions-selecting-and-preparing-correct-submission/biocompatibility-assessment-resource-center

Analysis of results. Conclusions. For device- and/or submission-specific biocompatibility questions, you may submit a pre-submission, as described in the Requests for Feedback …

Biocompatibility Evaluation Endpoints by Device …

https://www.fda.gov/medical-devices/biocompatibility-assessment-resource-center/biocompatibility-evaluation-endpoints-device-category

Note: On this page, FDA’s Biocompatibility Guidance on Use of ISO 10993-1 refers to Use of International Standard ISO 10993-1, "Biological evaluation of medical …

What Should I Put in a Test Report? | FDA

https://www.fda.gov/medical-devices/biocompatibility-assessment-resource-center/what-should-i-put-test-report

Safety of Metals and Other Materials Used in Medical …

https://www.fda.gov/medical-devices/products-and-medical-procedures/safety-metals-and-other-materials-used-medical-devices

The FDA accepted feedback through August 18, 2021 in a public docket FDA-2021-N-0334 . Numerous types of materials, including metals, polymers and …

Component and Device Documentation Examples

https://www.fda.gov/medical-devices/biocompatibility-assessment-resource-center/component-and-device-documentation-examples-test-articles-or-previously-marketed-devices

If the component documentation statement is true for all of the device component material formulations, processes, and sterilization methods (if applicable) in …

Biocompatibility Evaluation Endpoints by Contact …

https://www.fda.gov/medical-devices/biocompatibility-assessment-resource-center/biocompatibility-evaluation-endpoints-contact-duration-periods

Note: On this page, FDA’s Biocompatibility Guidance on Use of ISO 10993-1 refers to Use of International Standard ISO 10993-1, "Biological evaluation of medical …

Biocompatibility assessments for medical devices

https://pubmed.ncbi.nlm.nih.gov/28080154/

Abstract. Biocompatibility assessment provides key data supporting medical device development and marketing. Although regional and international guidance is available, …

Biocompatibility for Medical Devices | Solvay

https://www.solvay.com/en/chemical-categories/specialty-polymers/healthcare/assessing-biocompatibility-for-medical-devices-in-the-us

With that spirit in mind, we created this resource page to assist product development teams in meeting FDA biocompatibility assessment requirements the first time. ... 10993 test …