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In the draft guidance, FDA officials updated its recommendations so they apply to all transmissible spongiform encephalopathies, or TSEs, not just the widely known version of the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...
To view the full article, register now.
Law360 Pro Say Podcast
Check out Law360's new podcast, Pro Say, which offers a weekly recap of both the biggest stories and hidden gems from the world of law.