Biocompatibility testing is performed on medical devices to ensure that they will not cause any adverse effects once in contact with or implanted into a patient, and as a standard, all such devices ...

However, that costs time and money, and the document looks the same as the one on the FDA Web site. Due to the lack of easily obtainable information, an engineer or regulatory affairs officer may ...

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 ...