21 U.S.C. § 396

Current through P.L. 116-155 (8/8/2020)
Section 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.

21 U.S.C. § 396

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)1006,, 123 Stat. 1784.

EFFECTIVE DATESection effective 90 days after Nov. 21, 1997, except as otherwise provided, see section 501 of Pub. L. 105-115 set out as an Effective Date of 1997 Amendment note under section 321 of this title.