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To spare the legal explanation, it is technically acceptable for a doctor to prescribe non-FDA-approved drugs if certain precautions are met [4]: After review, if the [doctor] decides that there is sound medical evidence and it is in the patients best interest to use a non-FDA approved device, he or she should conduct and document a thorough and careful informed consent discussion

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Milewicz DM, Braverman AC, De Backer J, Morris SA, Boileau C, Maumenee IH, Jondeau G, Evangelista A, Pyeritz RE