[Download] "Northwest Tissue Center v. Donna E. Shalala 1 Secretary of United States Department of Health and" by United States Court of Appeals for the Seventh Circuit ~ Book PDF Kindle ePub Free
eBook details
- Title: Northwest Tissue Center v. Donna E. Shalala 1 Secretary of United States Department of Health and
- Author : United States Court of Appeals for the Seventh Circuit
- Release Date : January 27, 1993
- Genre: Law,Books,Professional & Technical,
- Pages : * pages
- Size : 93 KB
Description
BAUER, Chief Judge. In this appeal we revisit the United States Food and Drug Administration's (""FDA"") treatment of human heart valve allografts2 as devices under the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. §§ 301-394 (""the FDC Act"") and its implementing regulations. The district court dismissed the plaintiffs' complaint, ruling that it was mooted by our holding in Alabama Tissue Center v. Sullivan, 975 F.2d 373 (7th Cir. 1993). In Alabama Tissue, we dismissed a petition challenging an FDA notice interpreting one of its regulations because the notice was not a ""regulation"" subject to direct appellate review. Id. at 379. Although two of the plaintiffs' three claims were mooted by that ruling, we believe count three of the plaintiffs' complaint should not have been dismissed, and remand this case to the district court for proceedings consistent with this opinion. I. Background A. Statutory Framework Our review of the plaintiffs' claims requires us to delve into the bowels of the regulatory framework imposed by the FDC Act. The Medical Device Amendments of 1976 classify medical devices3 into three categories--Class I, II, and III--to reflect the devices' relative safety and effectiveness. 21 U.S.C. § 360c(a). Class I devices are the safest, followed by Class II, and then Class III. See 21 U.S.C. § 360c(a)(1). See also Becton, Dickinson, & Co. v. FDA, 589 F.2d 1175, 1177 (2d Cir. 1978) (discussing classification scheme). Examples of Class III devices include pacemakers, artificial heart valves, and other products intended to be implanted in the body or designed to sustain human life. 21 U.S.C. § 360c(2)(C)(i). The Act imposes significant restrictions on the marketing of Class III devices to minimize the risk of harm they pose to consumers. One of these requirements is premarket approval. 21 U.S.C. § 360e. Before a Class III device may be distributed commercially, manufacturers must submit extensive data to the FDA for review. The FDA examines the data and must approve the manufacturer's application before a device can be marketed. Id. Application for premarket approval is an onerous process, see 21 U.S.C. § 360e(c); Congress estimated that manufacturers would need thirty months to complete the process. 21 U.S.C. § 351(f)(2)(B)(i).