Alabama Tissue Center of University of Alabama Health Service Foundation v. Sullivan

975 F.2d 373
CourtCourt of Appeals for the Seventh Circuit
DecidedSeptember 16, 1992
DocketNo. 91-2738
StatusPublished
Cited by1 cases

This text of 975 F.2d 373 (Alabama Tissue Center of University of Alabama Health Service Foundation v. Sullivan) is published on Counsel Stack Legal Research, covering Court of Appeals for the Seventh Circuit primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

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Alabama Tissue Center of University of Alabama Health Service Foundation v. Sullivan, 975 F.2d 373 (7th Cir. 1992).

Opinion

SHABAZ, District Judge.

Six not-for-profit heart valve allograft processors filed a petition for review with this Court contesting the “Notice of Applicability of a Final Rule” (“NAFR”) published by the Food and Drug Administration (“FDA”) on June 26, 1991 at 56 Federal Register 29,177. The NAFR states that replacement heart valve allografts are subject to the final rule issued by the FDA on May 13, 1987, which requires the filing of a pre-market approval application (“PMA”) for all preamendment replacement heart valves and their equivalents. A heart valve allograft is a human heart valve which has been processed and preserved so it can be stored until needed for implantation into a human recipient. Because we conclude that we lack jurisdiction to entertain the petition for review of the NAFR, we dismiss the petition.

BACKGROUND

Statutory Framework

Provisions establishing a detailed procedure for regulating medical devices were added to the Food, Drug and Cosmetic Act of 1938 by the Medical Device Amendments of 1976 (“FDC Act”). See 21 U.S.C. §§ 360c-360i. The FDC Act defines “device” as:

[A]n instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory, which is—
(1) recognized in the official National Formulary, or the United States Pharmacopeia, or any supplement to them,
(2) intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or
(3) intended to affect the structure or any function of the body of man or other animals, and
which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of any of its principal intended purposes.

21 U.S.C. § 321(h) (emphasis added).

Medical devices are divided into three classes. 21 U.S.C. § 360c(a). Class III devices are the most regulated of the three and require premarket approval in accordance with 21 U.S.C. § 360e. See 21 U.S.C. § 360c(a)(l)(C). A Class III device, in relevant part, is one which cannot be classified as Class I or II for insufficient information to reasonably assure its safety and effectiveness and it “is purported or represented to be for a use in supporting or sustaining human life or for a use which is of substantial importance in preventing impairment of [375]*375human health_” 21 U.S.C. § 360c(a)(l)(C). A Class III device can be exempted from premarket approval if an investigational device exemption (“IDE”) is obtained pursuant to 21 U.S.C. § 360j(g).

The FDA is required to classify a device in distribution before the enactment of the Medical Device Amendments of 1976 or substantially equivalent to a preamendment device. 21 U.S.C. § 360c. For such a device categorized as a Class III device, the FDA is first required to promulgate a regulation classifying the device pursuant to 21 U.S.C. § 360c(d)(l). The FDA must then promulgate a regulation to require premarket approval under 21 U.S.C. § 360e(b). The FDA cannot require an approved PMA for a preamendment device prior to thirty months after the classification regulation becomes effective or ninety days after the promulgation of the regulation requiring premarket approval, whichever is later. 21 U.S.C. § 351(f)(2)(B).

Administrative Proceedings

In 1979 the FDA issued a proposed regulation classifying replacement heart valves as Class III medical devices pursuant to 21 U.S.C. § 360c. The FDA received no comments on the proposed regulation and accordingly it became final as proposed on February 5, 1980 (“1980 Regulation”). The 1980 Regulation defines “replacement heart valves” as:

[A] device intended to perform the function of any of the heart’s natural valves. This device includes valves constructed of prosthetic materials, biologic valves (e.g., porcine valves), or valves constructed of a combination of prosthetic and biologic materials.

21 C.F.R. § 870.3925(a).

The FDA then issued a proposed regulation in 1986 requiring (i) the filing of a PMA or a product development protocol (“PDP”) for preamendment replacement heart valves and their equivalents; and (ii) an approved PMA or a declared and completed PDP for any other replacement heart valve prior to commercial distribution. The FDA received only one comment and that was unrelated to the proposed regulation. None of the petitioners commented. The regulation, which amended the 1980 Regulation, was finalized on May 13, 1987 (“1987 Regulation”). See 21 C.F.R. § 870.3925(c). The 1987 Regulation required the filing of a PMA or a PDP for preamendment replacement heart valves and their equivalents by December 9, 1987. Id.

In 1989, perhaps with some reason for doing so, the FDA began notifying the industry of its intent to subsequently regulate heart valve allografts, believing it to be within its authority pursuant to the pri- or regulation. For example, in October 1989 the Center for Devices and Radiological Health of the FDA participated in a workshop on human heart valves sponsored by the American Association of Tissue Banks. Further, on August 20 and 21, 1990 the Circulatory System Devices Panel, an advisory committee of the FDA, held a public hearing to assist the heart valve allograft processors in subsequently complying with the premarket approval. The FDA’s proposed guidelines concerning the regulation of heart valve allografts were discussed at this meeting.

On June 26, 1991 the FDA published the NAFR. The summary of the NAFR states:

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975 F.2d 373, Counsel Stack Legal Research, https://law.counselstack.com/opinion/alabama-tissue-center-of-university-of-alabama-health-service-foundation-v-ca7-1992.