Opinion ID: 3010016
Heading Depth: 1
Heading Rank: 4

Heading: A. infra.

Text: We express no view on the validity of § 808.1(d)(1) because Shiley disclaimed all implied warranties as it was entitled to do under the Code. prohibition' limits the 1969 Act's pre-emptive scope to positive enactments by legislatures and agencies. Cipollone, 112 S. Ct. at 2620. D. Michael next argues that, while we could normally conclude that the FDA had imposed requirements on a manufacturer, the unique facts of this case preclude such a determination. Michael's argument is based on failings in the Premarket Approval and oversight process which arose because Shiley's heart valve was among the first mechanical devices approved under the MDA. According to Michael, these failings kept the FDA from imposing any requirements on Shiley. Michael claims that the lack of FDA requirements is proved by the absence of any specific regulations which govern heart valves as compared with the other medical devices. Cf. 21 C.F.R. § 813.1 - 813.170 (regulating the testing and manufacture of intraocular lenses); 21 C.F.R. § 870.1025 - 870.5925 (classifying and imposing requirements on various cardiovascular devices). To support this claim, Michael points to the FDA's statement that the MDA pre-empts state requirements only when the FDA has established specific counterpart regulations or there are other specific requirements applicable to a particular device under the act . . . . 21 C.F.R. § 808.1(d). The absence of regulations relating specifically to heart valves is not dispositive as long as the Shiley valve was subject to any requirement applicable under [the MDA] to the device. 21 U.S.C. § 360k(a)(1). While Shiley's premarket application may indeed have been flawed, there is ample evidence that the Shiley valve was subject to requirements under the MDA. First, it is clear that Shiley had to and did obtain a PMA prior to marketing the device. See 21 U.S.C. § 360e. After Premarket Approval was obtained, Shiley was subject to the labeling requirements of 21 C.F.R. § 801.1 - 801.16, which became effective February 13, 1976, and of 21 C.F.R. § 820.1 - 820.198, which defined the general good manufacturing practices (GMP) required of medical device manufacturers after July 21, 1978. See 41 Fed. Reg. 6896 (1976); 43 Fed. Reg. 31508 (1978). The FDA had the power to force notification of a previously unknown risk under 21 U.S.C. § 360h(a)5 and at least once threatened to use this power. 5 . 21 U.S.C. § 360h(a) reads in relevant part as follows: (a) Notification If the Secretary determines that-- (1) a device intended for human use which is introduced or delivered for introduction into interstate commerce for commercial distribution presents an unreasonable risk of substantial harm to the public health, and (2) notification under this subsection is necessary to eliminate the unreasonable risk of such harm and no more practicable means is available under the provisions of this chapter (other than this section) to eliminate such risk, the Secretary may issue such order as may be necessary to assure that adequate notification is provided in an appropriate form, by the persons and means best suited under the circumstances involved, to all health professionals who prescribe or use the device and to any other person (including manufacturer, importers, distributors, retailers, and device users) who should See app. 766-69. Even though these generally applicable regulations do not rise to the level of specificity present in the case of some other devices regulated by the FDA, we conclude that they present specific requirements applicable to a particular device under the act. 21 C.F.R. § 808.1(d). They therefore constitute proper bases for pre-emption under § 360k.