FDA To Lower Risk Category For Hemodialysis Devices

Law360, Washington (June 21, 2012, 2:37 PM EDT) -- The U.S. Food and Drug Administration released draft guidance Wednesday to lower the risk category associated with implanted blood access devices used for hemodialysis and provided additional instructions for manufacturers to comply with the new standards.

The devices have been considered class III — or the highest risk — devices since 1983, but the agency said its proposed controls could allow the products to be downgraded to class II. Affected devices include chronic hemodialysis catheters, AV shunt cannulae and subclavian catheters.

“FDA believes that special controls,...
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