in Attachment “A,” 814 F.Supp. 31, 31 (E.D.Tenn.1992) (“[T]he Court finds that Sporicidin’s disinfecting products are devices within the meaning of the FFDCA, 21 U.S.C. § 321(h) because they are intended for the mitigation and prevention of disease in man.... ”); United States v. 22 Rectangular or Cylindrical Finished Devices, 714 F.Supp. 1159, 1166 (D.Utah 1989) (“[T]he FDA’s inclusion of surgical instrument sterilizers within its device jurisdiction is rational.... ”). In summary, the wor t a device, because the FDA does not require dentists to sterilize their hand-pieces. Defendant again misunderstands the scope of the FFDCA. Because Steri-Safe satisfies the intended-use requirement, it is a “device” whether or not the FDA requires sterilization. See Drown, 198 F.2d at 1006 (<HOLDING>). Finally, defendant argues that SteriDot
holding that a machine that allegedly eliminated lumps from womens breasts was governed by the ffdca even though the fda did not require the use of such a machine holding that printouts from a breath test machine are not hearsay but rather the mechanicallygenerated reports automatically created by the machine they do not constitute outofcourt statements by any person or the conclusion of a third party not before the court   internal citations omitted holding that allegations that injuries were caused by misuse of ekg machine did not fall within waiver provisions of ttca because plaintiff had not made affirmative allegation that ekg machine was incorrectly used or that its results were erroneous and reasoning that misuse of information produced by ekg machine caused injuries rather than device itself holding that the manufacture of a machine from a copyrighted technical drawing is clearly not copyright infringement holding that state trade secret law could not protect vending machine mechanism where machine was sold to third party