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.
Notes of Decisions
Cited in 65
cases (10 in the last 5 years), 1998–2025 · leading case: Walter Shuker v. Smith & Nephew PLC, 885 F.3d 760 (3rd Cir. 2018).
Walter Shuker v. Smith & Nephew PLC, 885 F.3d 760 (3rd Cir. 2018). “" 21 U.S.C. § 396 . And physicians' ability to prescribe legally marketed devices as they see fit means that " 'off-label' usage," or use "for some other purpose than that for which [a device] has been approved by the FDA," is "an accepted and necessary corollary of the FDA's…”
Buckman Co. v. Plaintiffs' Legal Comm., 531 U.S. 341 (2001). “" 21 U. S. C. § 396 (1994 ed., Supp. V). Thus, the FDA is charged with the difficult task of regulating the marketing and distribution of medical devices without intruding upon decisions statutorily committed to the discretion of health care professionals.”
United States v. Caronia, 703 F.3d 149 (2d Cir. 2012). “21 U.S.C. § 396 (protecting physician authority to prescribe or administer any legally-marketed device to patient).”
Caplinger v. Medtronic, Inc., 784 F.3d 1335 (10th Cir. 2015). “Congress spoke directly to off-label uses in 21 U.S.C. § 396 . There legislators went out of their way to protect the liberty of doctors and patients to use approved devices in any 5 Neither do we understand our colleague’s separate writing as taking a different view.”
In Re Gilead Sciences Sec. Litig., 536 F.3d 1049 (9th Cir. 2008). “See 21 U.S.C. § 396 ; Buckman Co. v. Plaintiffs’Legal Comm.”
Riley v. Cordis Corp., 625 F. Supp. 2d 769 (D. Minnesota 2009). “” 21 U.S.C. § 396 (1994 ed., Supp. V). Thus, the FDA is charged with the difficult task of regulating the marketing and distribution of medical devices without intruding upon decisions statutorily committed to the discretion of health care professionals.”
The Judge Rotenberg Educ. Ctr., Inc. v. FDA, 3 F.4th 390 (D.C. Cir. 2021). “The petitioners contend that banning a medical device for a particular purpose regulates the practice of medicine in violation of 21 U.S.C. § 396 . We agree, grant the petitions for review, and vacate the FDA’s rule.”
United States Ex Rel. Nathan v. Takeda Pharm. North Am., Inc., 707 F.3d 451 (4th Cir. 2013). “See 21 U.S.C. § 396 . However, under the Federal Food, Drug, and Cosmetic Act, 21 U.”
United States v. Solvay Pharm., Inc., 871 F.3d 318 (5th Cir. 2017). “See 21 U.S.C. § 396 (“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…”
Mendez v. Shah, 28 F. Supp. 3d 282 (D.N.J. 2014). “”) (citing 21 U.S.C. § 396 (1994 ed., Supp. V) (emphasis added)).”
United States v. Michael Kaplan, 836 F.3d 1199 (9th Cir. 2016). “” (quoting 21 U.S.C. § 396 )). Kaplan’s argument that his reuse of the single-use guides was merely a permissible off-label use that cannot be criminally prosecuted fails for two reasons: the allegations of adulteration and the purpose of the off-label use.”
Clements v. Sanofi-Aventis, U.S., Inc., 111 F. Supp. 3d 586 (D.N.J. 2015). “Congress spoke directly to off-label use in 21 U.S.C. § 396 . There, as the Tenth Circuit Court of Appeals recently stated, the legislators went out of their way “to protect the liberty of doctors and patients to use approved devices in any manner they wish — including off-label…”
Annotations are extracted automatically from the opinions in the
Syfert caselaw corpus and ranked by authority, recency, and
treatment. Dots show Syfertize treatment of the citing case itself.