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All of the following statements about off-label device use are true except:

a. Physicians may use a device however they see fit, provided this use is in the best interests of the patient and is broadly within the standard of care

b. Companies sometimes generate significant revenues from the off-label use of their device

c. Start-ups should routinely evaluate strategies focused on off-label use as a mechanism for more quickly becoming cash-flow positive

d. Consultation with an experience regulatory experts is always advisable when evaluating issues related to off-label use of a company’s device

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