Court Opinion

ID: 9486633
Source: CourtListenerOpinion
Date Created: 2023-08-05 11:54:48.542369+00
Date Added: 2024-06-11T17:51:50.596707
License: Public Domain

COOK, Senior District Judge,
concurring in part and dissenting in part:
The statute in question 21 U.S.C. § 321(h)1 provides that a device must be intended for use in the diagnosis of disease or in the cure, mitigation, treatment, or pre*1030vention of disease. The government concedes that it does not claim that a device which has no medical application could “qualify as a device under the FDCA.” Appellee Brief, p. 16. There is no evidence present in the record that the containers involved here had any medical application.2 They were used only to “transport the specimens to the lab for analysis”. Appellee Brief, p. 12. Again, the government characterizes them as “generic collection containers”. Appellee Brief, p. 5. They were used, along with other materials, merely to contain and transport the specimens from one location to another, where, upon arriving at their destination, a totally independent and separate testing protocol was applied. It is the testing protocol which is the diagnosis. . Under the facts of this case, the containers played no part in the protocol of diagnosis. If an item’s participation in the mere transportation and containment of a specimen means that the item constitutes a “device” under the statute and regulations, then it could be argued that all means of transportation and containment so used would also qualify as a “device”. If the containers were required to be of special design as part of the protocol, a stronger argument could be made that they serve a use in diagnosis. From the evidence before us, these containers were perfectly ordinary. The conclusion that these ordinary containers were “used” in diagnosis can only be reached in the most attenuated sense, in the same way that a truck or airplane might be “used” in the transportation and/or containment process. The majority quite rightly says that the act must be liberally construed consistent with its overriding purpose to protect the public health. However, the majority’s reading goes beyond liberality to all-inclusiveness. For the above reasons, I respectfully dissent from Part I.

. A "device'' is defined as "... an instrument, apparatus ... in vitro reagent, or other similar or related article, ... which is ... 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

. 21 C.F.R. § 864.3250 generally describes specimen storage and transport containers as Class 1 devices. However, the statute contains the additional definitional requirement of use in diagnosis.