Should you let surgeons use devices off label?

November 2009
Same-Day Surgery;Nov2009, Vol. 33 Issue 11, p110
Academic Journal
Surgeons can decide to use a medical device in a manner that has not been approved by the Food and Drug Administration (FDA), if steps are taken to protect themselves, their patients, and their facilities. • Read FDA guidance issued earlier this year on unapproved new uses of cleared medical devices. • Ensure that the data support off-label use of the device and that surgery with an approved device is not an option. • Ensure that informed consent and documentation is thorough.


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