Mayo Clinic IDE violations due to misinterpretation of custom device regs.
This article was originally published in The Gray Sheet
Executive Summary
MAYO CLINIC "MISINTERPRETATION" OF CUSTOM DEVICE DEFINITION resulted in violations of FDA investigation device regulations cited by FDA in an Oct. 23 FDA warning letter to the clinic. In the letter, FDA says that Rochester, Minnesota-based Mayo Clinic failed to obtain the necessary investigational device exemption and investigational review board approval for its study of an artificial hip implant.