21 U.S.C. § 396

Practice of medicine

Nothing in this chapter shall be construed to limit or interfere with the authority of a health care practitioner to prescribe or administer any legally marketed device to a patient for any condition or disease within a legitimate health care practitioner-patient relationship. This section shall not limit any existing authority of the Secretary to establish and enforce restrictions on the sale or distribution, or in the labeling, of a device that are part of a determination of substantial equivalence, established as a condition of approval, or promulgated through regulations. Further, this section shall not change any existing prohibition on the promotion of unapproved uses of legally marketed devices.

( June 25, 1938, ch. 675, § 1006 , formerly § 906, as added Pub. L. 105–115, title II, § 214 , Nov. 21, 1997 , 111 Stat. 2348 ; renumbered § 1006, Pub. L. 111–31, div. A, title I, § 101(b)(2) , June 22, 2009 , 123 Stat. 1784 .)