(a) An evaluation of the health hazard presented by a product being recalled or considered for recall will be conducted by an ad hoc committee of Food and Drug Administration scientists and will take into account, but need not be limited to, the following factors:
(1) Whether any disease or injuries have already occurred from the use of the product.
(2) Whether any existing conditions could contribute to a clinical situation that could expose humans or animals to a health hazard. Any conclusion shall be supported as completely as possible by scientific documentation and/or statements that the conclusion is the opinion of the individual(s) making the health hazard determination.
(3) Assessment of hazard to various segments of the population, e.g., children, surgical patients, pets, livestock, etc., who are expected to be exposed to the product being considered, with particular attention paid to the hazard to those individuals who may be at greatest risk.
(4) Assessment of the degree of seriousness of the health hazard to which the populations at risk would be exposed.
(5) Assessment of the likelihood of occurrence of the hazard.
(6) Assessment of the consequences (immediate or long-range) of occurrence of the hazard.
(b) On the basis of this determination, the Food and Drug Administration will assign the recall a classification, i.e., Class I, Class II, or Class III, to indicate the relative degree of health hazard of the product being recalled or considered for recall.
Notes of Decisions
Banfi Prods. Corp. v. United States, 40 Fed. Cl. 107 (Fed. Cl. 1997).
· cites it 5× “7 21 C.F.R. § 7.41 (a). At the time relevant to this case, the ad hoc committee consisted of scientists working at CFSAN, was known as the Health Hazard Evaluation Board (HHEB), and its reports were called Health Hazard Evaluations (HHE).”
Wash. Cnty. Health Care Auth., Inc. v. Baxter Int'l Inc., 328 F. Supp. 3d 824 (E.D. Ill. 2018).
· cites it 2× “" 21 C.F.R. § 7.41 (a). In so doing, the FDA evaluates "whether any existing conditions could contribute to a clinical situation that could expose humans or animals to a health hazard," and assesses the likelihood and seriousness of the consequences posed by the hazard.”
Clark v. Actavis Grp. HF, 567 F. Supp. 2d 711 (D.N.J. 2008).
“See 21 C.F.R. §§ 7.41 (a)-(b) (2008). In collaboration with the recalling firm, the FDA “review[s] the adequacy of a proposed recall strategy developed by a recalling firm and recommend[s] changes as appropriate.”
Gates v. Medtronic, Inc., 192 F. Supp. 3d 704 (W.D. Tex. 2016).
· cites it 2× “§ 360h(e)(2) (granting FDA authority over device recall orders and timetables); see also 21 C.F.R. § 7.41 (b) (describing FDA methodology in assessing device recall classification).”
Fisher Bros. Sales v. United States, 46 F.3d 279 (3rd Cir. 1995).
· cites it 2× “" 21 C.F.R. § 7.41 (a)(4),(5). already been conducted, the probability that contaminated grapes, if they existed, would be consumed, and probable consequences of any such consumption to the person poisoned, fruit consumers in general, and to the fruit industry as a whole.”
Washington Cnty. Health Care Auth., Inc. v. Baxter Int'l Inc. (N.D. Ill. 2018).
“21 C.F.R. § 7.41 (b). As the defendants point out, by initiating a fake recall in furtherance of an illegal agreement to restrict output would invite—require, actually—the government to scrutinize the artifice through which the unlawful collusion occurred.”
— 21 C.F.R. § 7.41(b) — 1 case
Banfi Prods. Corp. v. United States, 40 Fed. Cl. 107 (Fed. Cl. 1997).
“7 21 C.F.R. § 7.41 (a). At the time relevant to this case, the ad hoc committee consisted of scientists working at CFSAN, was known as the Health Hazard Evaluation Board (HHEB), and its reports were called Health Hazard Evaluations (HHE).”
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