21 U.S.C. § 396 — Practice of medicine

submitted 88 years ago by Pub. L. 105-115 to r/title-21-FOOD-AND-DRUGS · 108 words · no verdicts yet

in plain englishAI-generated · not legal advice

This law protects a doctor's right to prescribe legally marketed medical devices for any patient condition. It does not limit the Secretary's existing power to restrict how a device is sold, distributed, or labeled. It also does not change existing bans on promoting unapproved uses of devices.

Nothing in this chapter limits or interferes with a health care practitioner's authority to prescribe or give a patient any legally marketed device, for any condition or disease, within a legitimate health care practitioner-patient relationship. This section does not limit the Secretary's existing authority to create and enforce restrictions on how a device is sold, distributed, or labeled — as long as those restrictions are part of a "substantial equivalence" determination, a condition of approval, or a regulation. This section also does not change any existing rule against promoting unapproved uses of legally marketed devices.

the actual law source: uscode.house.gov ↗public domain

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.

Source credit: (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.)

history & why it existsrecord from the source credit

1938Enacted · Pub. L. 105-115 · 111 Stat. 2348
2009Amended · Pub. L. 111-31 · 123 Stat. 1784

A history note hasn’t been published yet. The record shows enactment by Pub. L. 105-115 on 1938-06-25.

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