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]: lease, for the first time in his reply brief, thus, he has waived it. In most circumstances a litigant who fails to raise an argument until his reply brief wül be deemed to have waived that argument. Wilson v. O’Leary, 895 F.2d 378, 384 (7th Cir. 1990). This case is before us, however, on a motion for dismissal pursuant to Rule 12(b)(6). The inquiry we are faced with is whether the plaintiff can prove any set of facts to support his allegation. Conley v. Gibson, 355 U.S. 41, 45-46, 78 S.Ct. 99, 101-02, 2 L.Ed.2d 80 (1957). This court has held that when reviewing Rule 12(b)6) motions, we wül consider new factual allegations raised for the first time on appeal provided they are consistent with the complaint. See Hrubec v. National R.R. Passenger Corp., 981 F.2d 962, 963-64 (7th Cir.1992) (<HOLDING>); Dawson v. General Motors Corp., 977 F.2d 369, 
 Holding statements: (A) holding that a court in deciding a rule 12b6 motion may consider a document that is incorporated by reference into the complaint (B) holding that the essential inquiry in conversion of a rule 12b6 motion to a rule 56 motion is whether the appellant should reasonably have recognized the possibility that the motion might be converted into one for summary judgment or was taken by surprise and deprived of a reasonable opportunity to meet facts outside the pleadings (C) holding that a plaintiff may attempt to survive a rule 12b6 motion by adding essential new facts in a brief on appeal (D) holding that class claims that fail to meet the requirements of rule 23 may be properly dismissed by granting a rule 12b6 motion (E) holding that plaintiff cannot introduce new allegations or new facts in opposition to a motion to dismiss
[EX A]: (C)

[EX Q]: contents of Form 4549). 16 . Perez further argues that Form 4549 requires the explicit approval of the IRS’s District Director in order for it to be effective. He derives this argument from the last line of Form 4549, which states that the taxpayer understands "that this report is subject to acceptance by the District Director.” In this case, the Form 4549 was signed only by the IRS examiner. We reject Perez’s contention that an IRS examiner is not a duly authorized agent of the district director capable of accepting a Form 4549. In re Barry, 48 B.R. at 603 ("A revenue agent is a delegate of the district director authorized to accept waivers. His signature is sufficient 'acceptance' of this [IRS Form 4549] waiver.”). Cf. Holbrook v. United States, 284 F.2d 747 (9th Cir.1960) (<HOLDING>). 17 . See 26 U.S.C. §§ 6212-6213. 18 . 
 Holding statements: (A) holding that the point on appeal and the objection in the trial court must be the same in order for it to be preserved for appeal (B) holding that it is not (C) holding that it is not necessary for the irs commissioner to personally consent to a taxpayer waiver in order for it to be effective (D) holding officer personally liable because he agreed to personally guarantee payment on an account (E) holding that persons knowledge of his right to refuse a consent to search is a factor but not a necessary prerequisite to demonstrating a voluntary consent
[EX A]:
(C)