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
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 sectionof this title.