21 C.F.R. § 812.5

Labeling of investigational devices

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(a) Contents. An investigational device or its immediate package shall bear a label with the following information: the name and place of business of the manufacturer, packer, or distributor (in accordance with § 801.1), the quantity of contents, if appropriate, and the following statement: “CAUTION—Investigational device. Limited by Federal (or United States) law to investigational use.” The label or other labeling shall describe all relevant contraindications, hazards, adverse effects, interfering substances or devices, warnings, and precautions.

(b) Prohibitions. The labeling of an investigational device shall not bear any statement that is false or misleading in any particular and shall not represent that the device is safe or effective for the purposes for which it is being investigated.

(c) Animal research. An investigational device shipped solely for research on or with laboratory animals shall bear on its label the following statement: “CAUTION—Device for investigational use in laboratory animals or other tests that do not involve human subjects.”

(d) The appropriate FDA Center Director, according to the procedures set forth in § 801.128 or § 809.11 of this chapter, may grant an exception or alternative to the provisions in paragraphs (a) and (c) of this section, to the extent that these provisions are not explicitly required by statute, for specified lots, batches, or other units of a device that are or will be included in the Strategic National Stockpile.

[45 FR 3751, Jan. 18, 1980, as amended at 45 FR 58842, Sept. 5, 1980; 72 FR 73602, Dec. 28, 2007]

Notes of Decisions

Cited in 8 cases (1 in the last 5 years), 1995–2022 · leading case: Ada M. Martin & Harold L. Martin v. Telectronics Pacing Sys., Inc. Tplc, Inc. D/B/A Telectronics Pacing Sys. Telectronics Pty Ltd., 105 F.3d 1090 (6th Cir. 1997).

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Ada M. Martin & Harold L. Martin v. Telectronics Pacing Sys., Inc. Tplc, Inc. D/B/A Telectronics Pacing Sys. Telectronics Pty Ltd., 105 F.3d 1090 (6th Cir. 1997). · cites it 2× “” 21 C.F.R. § 812.5 (a). In addition, during the application process, the manufacturer must submit the label to the FDA for its review.”

Femrite v. Abbott Nw. Hosp., 568 N.W.2d 535 (Minn. Ct. App. 1997). · cites it 2× “, 21 C.F.R. § 812.5 (1996) (requiring investigational device to be labeled as such); 21 C.”

Connelly v. Iolab Corp., 927 S.W.2d 848 (Mo. 1996). “For example, 21 C.F.R. § 812.5 governs the contents of investigational device labels, and § 812.”

Bourquin v. Melsungen, 670 A.2d 1322 (Conn. App. Ct. 1996). “’ ”21 C.F.R. § 812.5 (a) (1995). Before any IDE may be used on a patient, an informed consent must be obtained.”

Guckin v. Nagle, 259 F. Supp. 2d 406 (E.D. Pa. 2003). “20 (b)(3), whether the product labeling is complete, 21 C.F.R. § 812.5 , and whether the consent materials comply with the provisions of 21 C.”

28 Ucc rep.serv.2d 531, prod.liab.rep. (Cch) P 14,411 Ada M. Martin Harold L. Martin v. Telectronics Pacing Sys., Inc., 70 F.3d 39 (6th Cir. 1995). “7 prevents the commercialization and promotion of in-vestigational devices, and prohibits any representation that “an investigational device is safe or effective for the purposes for which it is being investigated”; and § 812.”

Reinoehl v. Centers for Disease Control & Prevention (N.D. Ind. 2022). “166, and 21 CFR § 812.5 .” Alongside the CDC and Dr.”

Robinson v. Endovascular Tech., Inc., 190 Cal. App. 4th 1490 (Cal. Ct. App. 2010). “In addition to listing the relevant contraindications, hazards, adverse effects, warnings and precautions that must be included on the labeling, the FDA also requires that the labeling “shall not bear any statement that is false or misleading in any particular and shall not…”

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