Contact Lens Manufacturers Association v. Food and Drug Administration

Congress enacted the Medical Device Amendments (MDA) of 1976 to extend the Food and Drug Administration’s (FDA) pre-market approval authority to include medical devices. No Class III device can be sold without pre-market approval from the FDA, which is a costly and time-consuming process. Devices introduced after the MDA was enacted are Class III devices unless they are substantially equivalent to a device already on the market. Under provisions labeled transitional, a Class III ranking automatically attaches to any device the FDA previously declared to be a new drug. The FDA may reclassify a transitional device upon valid scientific evidence of the device’s safety and effectiveness. Hard contact lenses had been marketed in the United States since the early 1950s, and there was a pending proposal to classify them as Class II devices. And since 1975, soft contact lenses were considered new drugs, placing them in Class III under the MDA’s transitional provisions. Consequently, before a manufacturer could market a particular rigid gas permeable (RGP) lens to the public, it had to demonstrate the safety and effectiveness of the lens to gain FDA pre-market approval. If, however, RGP lenses were Class I devices, a manufacturer would only have to show that its lens was substantially equivalent to another RGP already on the market. The Contact Lens Manufacturers Association (Association) sought review of an FDA order withdrawing the FDA’s previous proposal to reclassify RGP) lenses, which shared characteristics of both hard and soft contact lenses, to a less restrictive classification, presenting the court with a case of first impression under the MDA’s transitional provisions. The Association argued that the FDA’s decision was improper because the FDA disparaged studies it previously acclaimed and it refused to concede the safety and effectiveness of RGP lenses now on the market.