C.F.R. » Title 21 » CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES › SUBCHAPTER A—GENERAL › PART 7—ENFORCEMENT POLICY › Subpart A—General Provisions

21 C.F.R. § 7.3

Definitions

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(a) Agency means the Food and Drug Administration.

(b) Citation or cite means a document and any attachments thereto that provide notice to a person against whom criminal prosecution is contemplated of the opportunity to present views to the agency regarding an alleged violation.

(c) Respondent means a person named in a notice who presents views concerning an alleged violation either in person, by designated representative, or in writing.

(d) Responsible individual includes those in positions of power or authority to detect, prevent, or correct violations of the Federal Food, Drug, and Cosmetic Act.

(e) [Reserved]

(f) Product means an article subject to the jurisdiction of the Food and Drug Administration, including any food, drug, and device intended for human or animal use, any cosmetic and biologic intended for human use, any tobacco product intended for human use, and any item subject to a quarantine regulation under part 1240 of this chapter. Product does not include an electronic product that emits radiation and is subject to parts 1003 and 1004 of this chapter.

(g) Recall means a firm's removal or correction of a marketed product that the Food and Drug Administration considers to be in violation of the laws it administers and against which the agency would initiate legal action, e.g., seizure. Recall does not include a market withdrawal or a stock recovery.

(h) Correction means repair, modification, adjustment, relabeling, destruction, or inspection (including patient monitoring) of a product without its physical removal to some other location.

(i) Recalling firm means the firm that initiates a recall or, in the case of a Food and Drug Administration-requested recall, the firm that has primary responsibility for the manufacture and marketing of the product to be recalled.

(j) Market withdrawal means a firm's removal or correction of a distributed product which involves a minor violation that would not be subject to legal action by the Food and Drug Administration or which involves no violation, e.g., normal stock rotation practices, routine equipment adjustments and repairs, etc.

(k) Stock recovery means a firm's removal or correction of a product that has not been marketed or that has not left the direct control of the firm, i.e., the product is located on premises owned by, or under the control of, the firm and no portion of the lot has been released for sale or use.

(l) Recall strategy means a planned specific course of action to be taken in conducting a specific recall, which addresses the depth of recall, need for public warnings, and extent of effectiveness checks for the recall.

(m) Recall classification means the numerical designation, i.e., I, II, or III, assigned by the Food and Drug Administration to a particular product recall to indicate the relative degree of health hazard presented by the product being recalled.

(1) Class I is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.

(2) Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.

(3) Class III is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.

(n) Consignee means anyone who received, purchased, or used the product being recalled.

[42 FR 15567, Mar. 22, 1977, as amended at 43 FR 26218, June 16, 1978; 44 FR 12167, Mar. 6, 1979; 77 FR 5176, Feb. 2, 2012]
Notes of Decisions
Cited in 10 cases (1 in the last 5 years), 2008–2023 · leading case: Wash. Cnty. Health Care Auth., Inc. v. Baxter Int'l Inc., 328 F. Supp. 3d 824 (E.D. Ill. 2018).
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Wash. Cnty. Health Care Auth., Inc. v. Baxter Int'l Inc., 328 F. Supp. 3d 824 (E.D. Ill. 2018). · cites it 3× “" 21 C.F.R. § 7.3 (m)(1). A Class II recall "is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious health consequences is remote.”
New Jersey Carpenters Pension & Annuity Funds v. Biogen Idec Inc., 537 F.3d 35 (1st Cir. 2008). “” 21 C.F.R. § 7.3 (j). A recall is "a firm's removal or correction of a marketed product that the [FDA] considers to be in violation of the laws it administers and against which the agency would initiate legal action.”
Blanco v. Baxter Healthcare Corp., 64 U.C.C. Rep. Serv. 2d (West) 790 (Cal. Ct. App. 2008). “” ( 21 C.F.R. § 7.3 (m)(l) (2007).) 5 We have received two requests for judicial notice.”
Cline v. Advanced Neuromodulation Sys., Inc., 17 F. Supp. 3d 1275 (N.D. Ga. 2014). · cites it 2× “” 8 21 C.F.R. § 7.3 (g). Manufacturers are free to remove or correct a distributed product on their own initiative, but “[a] firm that does so because it believes the product to be violative is requested to notify” the FDA.”
Velazquez v. Abbott Labs., 901 F. Supp. 2d 279 (D.P.R. 2012). “” 21 C.F.R. § 7.3 (g). . Exhibit B, FDA Notice of September 27, 2010; Exhibit C, id.”
Freedman v. Saint Jude Med., Inc., 4 F. Supp. 3d 1101 (D. Minnesota 2014). “” 21 C.F.R § 7.3(g), (m)(l). By that time, SJM’s silicone-insulated leads, thousands of which remained implanted in patients, were the subject of intense scrutiny, and concern was growing that SJM’s Optim-insulated leads could be prone to the same problems.”
Washington Cnty. Health Care Auth., Inc. v. Baxter Int'l Inc. (N.D. Ill. 2018). · cites it 2× “” 21 C.F.R. § 7.3 (m)(1). A Class II recall “is a situation in which use of, or exposure to, a 6 Nor is this an impossible requirement; the plaintiffs acknowledge, for instance, that there is public information that would bear on the question (and which they intend to pursue).”
ASEA/AFSCM Local 52 health v. St. Jude Med., LLC, 362 F. Supp. 3d 642 (D. Me. 2019). “¶ 105 (quoting 21 C.F.R. § 7.3 (m) ). Proposed class members include TPPs that paid for the defective devices and/or are responsible for the costs of removing and replacing the defective devices.”
ASEA/AFSCME Local 52 Health Benefits Trust v. St. Jude Med., LLC (D. Minnesota 2019). “¶ 105 (quoting 21 C.F.R. § 7.3 (m)). 3 St. Jude has offered to reimburse patients for expenses not covered by insurance relating to device removal and replacement.”
Asby v. Medtronic, Inc. (E.D.N.C. 2023). “” 21 C.F.R. § 7.3 (m)(2); see Compl. ff 21, 472 The complaint also alleges that, around the time of the recall, the FDA issued a report on malfunctions of surgical staplers which included data on staplers “designed, manufactured, and marketed by Defendants.”
— 21 C.F.R. § 7.3(g) — 1 case
Freedman v. Saint Jude Med., Inc., 4 F. Supp. 3d 1101 (D. Minnesota 2014). “” 21 C.F.R § 7.3(g), (m)(l). By that time, SJM’s silicone-insulated leads, thousands of which remained implanted in patients, were the subject of intense scrutiny, and concern was growing that SJM’s Optim-insulated leads could be prone to the same problems.”
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