Although not required by regulation, which of the following actions does FDA guidance recommend for clinical use of a HUD outside of its approved indication (s) ? a. Restrict use outside of approved indication (s) for situations that meet emergency use criteria. b. Obtain informed consent from the patient and ensure that reasonable patient protection measures are followed. c. Request that the HDE holder submit an HDE supplement to obtain FDA approval of use outside of the approved indication (s). d. Limit use outside of approved indication (s) as these uses count towards the FDA-assigned number of devices allowed to be shipped or sold in a year.
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