Act of June 25, 1938, ch. X, sec. 1006 (as amended)
PRACTICE OF MEDICINE.
SEC. 1006. [21 U.S.C. 396] PRACTICE OF MEDICINE.
Nothing in this Act 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.
- Cross-references to the US Code
- 21 U.S.C. 396