The U.S. Food and Drug Administration (FDA) published an updated final guidance on the use of International Standard ISO 10993-1, “Biological evaluation of medical devices - Part 1: Evaluation and ...
This story was originally published on MedTech Dive. To receive daily news and insights, subscribe to our free daily MedTech Dive newsletter. The document, which the FDA released Thursday, is the ...
Medical device manufacturers use cytotoxicity testing to help prove that devices that come into contact with the human body are biocompatible. Testing results are critical for gaining market access, ...
The evolution of medical-grade thermoplastic polyurethanes (TPUs) continues to reshape possibilities for device manufacturers seeking materials that combine flexibility, durability and ...
Silicone elastomers are well accepted in the healthcare industry. They meet biocompatibility standards and have advantageous properties like purity, clarity, strength, and chemical compatibility, as ...
In April 2013, FDA released draft guidance for industry and FDA administration staff titled “Use of International Standard ISO 10993, ‘Biological Evaluation of Medical Devices Part 1: Evaluation and ...
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