www.fdanews.com/articles/162268-fda-revises-standards-list
FDA Revises Standards List
February 7, 2014
The FDA has updated the list of consensus standards it references during premarket reviews. The dozens of revisions touch on areas including software, biocompatibility testing, orthopedics and anesthesia. Some standards have been withdrawn and replaced with a newer standard; others expand the extent of a standard’s recognition.
Devices & Diagnostics Letter
Devices & Diagnostics Letter