Contact Lens Manufacturers Association v. Food & Drug Administration of the Department of Health and Human Services

Opinion for the Court filed by Circuit Judge GINSBURG.

GINSBURG, Circuit Judge.

In 1938, Congress armed the Food and Drug Administration (FDA) with authority to prevent the marketing of hazardous drugs. By the mid-1970’s, however, it had become apparent that the legislature’s delineation of the FDA’s domain was too narrow to enable the agency to protect the public from some of the most dangerous health care products. Mindful of recent misfortunes involving faulty pacemakers and the Daikon Shield, Congress enacted the Medical Device Amendments of 1976 (Amendments or statute), Pub.L. No. 94-295,…