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 ...
The biocompatibility, or reaction of some zirconia ceramics, in particular 3mol% yttria stabilised tetragonal zirconia polycrystal (3Y-TZP) to physiological environments or simulated physiological ...
Durotomy frequently results in cerebrospinal fluid leakage, leading to serious secondary complications. Tissue adhesives have ...
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 ...
Photothermal therapy, as an emerging cancer treatment method, has attracted significant attention due to its advantages such ...
The contract research organization will launch an expanded ISO 18562 gas pathway testing program and ISO 10993-18 particulate ...
In April 2013, FDA released draft guidance for industry and FDA administration staff titled “Use of International Standard ISO 10993, ‘Biological Evaluation of Medical Devices Part 1: Evaluation and ...
Mg alloys have received considerable attention as biomaterials due to their biocompatibility, biodegradability, and density and elastic modulus comparable to bone. These qualities make them suitable ...
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