In this task, you will be shown a prompt from a judicial decision and multiple holding statements derived from citations following text in a legal decision.  Holdings represent the governing legal rule when the law is applied to a particular set of facts. There are five answer choices for each citing text. The correct answer is the holding statement that corresponds to the citing text. The four incorrect answers are other holding statements. You should find the correct option. There is a <HOLDING> token in the position of the citing text prompt where the holding statement was extracted.

[EX Q]: of the statute, the FDA’s regulations, the FDA’s internal interpretation, and precedent all demonstrate that a sterilizer for dental hand-pieces is a “device” as that term is defined in 21 U.S.C. § 321(h). That being so, both SteriSafe and its accessory SteriDot are within the jurisdiction of the FFDCA. Defendant nevertheless posits three reasons why SteriSafe and SteriDot are not devices. First, defendant argues that the government failed to prove that dental handpieces transmit disease and, thus, that SteriSafe actually prevents disease. Such proof is not required. Congress had two purposes in enacting' the FFDCA: (1) to regulate products that actually prevent disease, and (2) to regulate products that falsely claim that they prevent disease. Because of those d 1006 (9th Cir.1952) (<HOLDING>). Defendant next argues that the Steri-Safe is 
 Holding statements: (A) holding that because the doctor who submitted an expert report did not demonstrate knowledge of cancer treatment he was not qualified to offer an opinion that an earlier diagnosis could have produced a better outcome for the plaintiff (B) holding that a machine that allegedly eliminated lumps from womens breasts was governed by the ffdca even though expert witnesses expressed the unanimous belief that appellants instruments are useless for diagnosis or treatment of any human ailment (C) holding the expert witnesses were protected by witness immunity to ensure expert objectivity (D) holding in a case where there was no evidence that the expert was incompetent or that the petitioners lawyers had any reason to question the experts professional qualifications that it was objectively reasonable for  trial counsel to rely upon the experts diagnosis (E) holding that the admissibility of expert testimony was governed by state law
[EX A]: (B)

[EX Q]: to that extent. Reed, supra, at 17, 104 S.Ct. 2901. The holding in Cage represents a degree of novelty sufficient to constitute cause. As such, Mercer has established cause to avoid otherwise procedurally defaulting on his claim challenging the reasonable doubt instruction. Sufficient prejudice to establish federal habeas jurisdiction also exists. In particular, the Supreme Court has held that the Fifth Amendment requirement of proof beyond a reasonable doubt in criminal cases is so intertwined with the Sixth Amendment right to a jury verdict that a constitutionally deficient jury instruction cannot produce a guilty verdict comporting with due process but, rather, requires reversal of a conviction. Sullivan v. Louisiana, 508 U.S. 275, 277-80, 113 S.Ct. 2078, 124 L.Ed.2d 182 (1993) (<HOLDING>). It follows that a claimed Cage violation 
 Holding statements: (A) recognizing that where the error involved defies analysis by harmless error standards or the data is insufficient to conduct a meaningful harmless error analysis then the error will not be proven harmless beyond a reasonable doubt (B) holding exclusion was harmless error (C) holding that when defendant properly objects to charge error reversal required unless error was harmless (D) holding that any error was harmless and thus not plain error (E) holding a cage violation could never be held harmless error and thus not amenable to harmless error review but rather required outright reversal
[EX A]: (E)

[EX Q]: Duke neither reported nor evaluated this diagnosis. Further, one month prior to the filing of this suit, Dr. Chen, a Duke cardiopulmonary radiolo error. II. Next, Duke argues that the trial court erred in denying its motion for JNOV because there was no competent evidence that “any of the treating physicians alleged to have been negligent was an agent of Duke.” A motion for JNOV is treated as a renewal of the motion for directed verdict. See Maintenance Equip. Co. v. Godley Builders, 107 N.C. App. 343, 353, 420 S.E.2d 199, 204 (1992); N.C. Gen. Stat. § 1A-1, Rule 50(b)(1) (1990). Thus, a movant cannot assert grounds on a motion for JNOV that were not previously raised in the directed verdict motion. See Lassiter v. English, 126 N.C. App. 489, 492-93, 485 S.E.2d 840, 842 (1997) (<HOLDING>). Because Duke never asserted this agency 
 Holding statements: (A) holding that some evidence was presented to support the jurys verdict that defendant breached contract and therefore trial court did not err in denying defendants motion for directed verdict or jnov (B) holding that objection made at directed verdict stage and in motion for new trial were timely (C) holding party that filed motions for summary judgment directed verdict and jnov preserved complaint drat issue should not have been submitted to jury even though party submitted jury questions on same issue (D) holding that a party must have made a directed verdict motion at trial on the specific issue which is the basis of the jnov (E) holding that the trial court erred in granting the school boards posttrial motion for directed verdict because although the school board timely moved for a directed verdict during trial it did not serve its motion for directed verdict until the eleventh day after the verdict
[EX A]:
(D)