FDA Updates Mad Cow Disease Guidance For Medical Devices
Law360, New York (January 22, 2014, 5:51 PM EST) -- The U.S. Food and Drug Administration on Wednesday advised medical device makers on how to ensure that products made with animal components don't end up transmitting infectious diseases, expanding previous policies related to mad cow disease.
In the draft guidance, FDA officials updated its recommendations so they apply to all transmissible spongiform encephalopathies, or TSEs, not just the widely known version of the degenerative brain disorder that's linked to cattle.
A wide array of medical devices are derived from animal tissues. For example, bovine materials are used to make heart valves, dental implants, tear duct plugs and sutures.
The TSEs, which...
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