## Facts

- Six not-for-profit processors collected, processed, preserved, and supplied human heart valve allografts for implantation into patients.
- A heart valve allograft is a human heart valve that has been processed and preserved so it can be stored until needed for implantation.
- The Medical Device Amendments to the Federal Food, Drug, and Cosmetic Act (FDCA) regulate “devices,” classify them by risk, and require premarket approval (PMA) for certain Class III devices.
- FDA regulations classified “replacement heart valves” as Class III devices; the regulatory definition included valves made of prosthetic materials, biologic materials (e.g., porcine), or combinations of both.
- In 1987, FDA issued a final rule requiring PMAs (or product development protocols) for pre-amendment replacement heart valves and devices found substantially equivalent to them.
- On June 26, 1991, FDA published a “Notice of Applicability of a Final Rule” (NAFR) stating that replacement heart valve allografts are subject to the existing PMA requirement for replacement heart valves and their equivalents.
- The processors contended FDA never meant to include human heart valve allografts within “replacement heart valves,” and argued allografts were not “implants” within the FDCA’s definition of “device.”
- The processors filed a petition for review directly in the Seventh Circuit, invoking FDCA provisions they claimed authorized direct appellate review of the NAFR.
- FDA moved to dismiss the petition, arguing the court of appeals lacked subject-matter jurisdiction; the processors also filed a separate district court action challenging the NAFR.

## Issues

1. Whether 21 U.S.C. § 360g(a) (or any other FDCA provision) grants the court of appeals jurisdiction to directly review the FDA’s NAFR stating that heart valve allografts are subject to the PMA requirement for replacement heart valves.
2. If the court of appeals lacks direct-review jurisdiction, whether the proper forum for challenging the NAFR is federal district court under general federal-question and Administrative Procedure Act review.

## Decision

- The Seventh Circuit dismissed the petition for lack of jurisdiction.
- The court held that courts of appeals have only the jurisdiction Congress expressly grants, and the FDCA provision invoked did not authorize direct appellate review of this type of agency action.
- The NAFR was treated as a notice clarifying the scope of an existing rule, not an “order” or other action Congress routed to direct review in the courts of appeals.
- Because no statute provided for direct review of the NAFR in the court of appeals, any challenge must be brought in district court, where review is available under an appropriate jurisdictional basis.

## Legal Principles

- A federal court of appeals may review agency action directly only when Congress has expressly provided that route of review.
- Specialized FDCA direct-review provisions are limited to the actions they name; they do not create general appellate jurisdiction over FDA statements or notices.
- When a statute does not specify direct appellate review for a given agency action, review ordinarily proceeds in federal district court (commonly through federal-question jurisdiction and the APA).

## Conclusion

Alabama Tissue Center v. Sullivan is a jurisdiction-only decision: the Seventh Circuit held it lacked statutory authority to hear a direct petition challenging FDA’s NAFR applying the PMA requirement for replacement heart valves to human heart valve allografts, leaving any substantive attack on the notice for district court review.


Alabama Tissue Center v. Sullivan, 975 F.2d 373 (1992)