Americans spend billions of dollars annually on health and fitness medical products, such as heart rate monitors, blood pressure kits, body massagers and relaxation aids. These products are typically purchased without prescription in such places as pharmacies, health food stores or shops selling sports and exercise equipment. With the boom in e-commerce over the Internet, dozens of web sites have sprung up virtually overnight where consumers can directly purchase these quasi-medical devices.
The sellers of these health and fitness medical products encourage consumers to purchase devices to track their heart rates or blood pressure during exercise. These same products are also sold for "cardiac rehabilitation" or use after surgery. The danger obviously exists that some consumers may use such products irresponsibly as a substitute for regular visits to their doctors or may not know how to properly use these devices. As a result, consumers may misdiagnose their medical conditions or fail to seek necessary medical treatment.In light of the increasing popularity of these quasi-medical devices, the question whether the Food and Drug Administration ("FDA") should regulate the manufacture and marketing of these devices to ensure public safety has become increasingly important. The answer depends in part on whether the FDA even has jurisdictional authority over such devices. As discussed below, it is unclear to what extent the FDA can or will attempt to assert jurisdiction over such health and fitness products that are marketed directly to the consumer over the Internet or in stores. The reason for this uncertainty is that few, if any, courts have addressed the issue in the context of the exploding market for such products.
FDA Jurisdiction
Pursuant to the Federal Food, Drug and Cosmetic Act ("FDCA"), 21 U.S.C. ' 321(h), so-called "medical devices" are placed into one of three categories, depending upon the degree of regulation necessary to ensure their safety and effectiveness. Devices creating the lowest risk are placed in Class I and subject to minimal regulation, whereas devices placed in Class II create a higher level of risk than those in Class I and are subject to additional controls to ensure their safety. 21 U.S.C. ' 360c(a)(1)(A), (B).
Class III devices pose the greatest risk and thus command the most scrutiny. Importantly, any device that was not on the market before May 28, 1976, is automatically classified as a Class III device unless it falls within one of several exceptions not relevant here. 21 U.S.C. ' 360c(f)(1). Class III devices cannot be marketed unless either: (1) the manufacturer submits a "premarket notification" arguing that its device should be reclassified as Class I or II because it is substantially equivalent to an existing device so categorized and the FDA finds the devices are in fact so equivalent; or (2) the manufacturer has submitted to the FDA an application for premarket approval (PMA) and receives approval. 21 U.S.C. ' 360c.
PMA requires the manufacturer to file an application demonstrating that the device is safe and effective and describing the components and properties of the device, the methods used in manufacturing and packaging the device, and the proposed labeling for the device. 21 U.S.C. ' 360e(c)(1). Additionally, PMA allows only that particular applicant to market the device. With limited exceptions, if another manufacturer desires to market its own version of the same device, it must go through the PMA process anew. Under this broad regulatory scheme, the pertinent issue is whether the types of health and fitness devices now commonly being sold directly to consumers constitute "medical devices."
The FDCA defines a "medical device" as any "contrivance" (a) intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, or (b) intended to affect the structure or any function of the body . and which does not achieve its primary intended purposes through chemical action . and which is not dependent upon being metabolized for the achievement of its primary intended purposes." 21 U.S.C. ' 321(h)(2), (3). In determining whether a product is a "medical device," the critical factor is the objective intent of the manufacturer as manifested by "labeling claims, advertising matter, or oral or written statements by [the manufacturer or its representatives]." 21 C.F.R. ' 801.4 (1994). Accordingly, the FDA will assert jurisdiction over those products that have an intended diagnostic or therapeutic use or effect.
Expansive Interpretation of "Device"
Not many cases or regulatory rulings offer insight as to how the FDA will address the recent explosion of direct sales to consumers of heart monitors or similar devices, and those cases that provide a measure of guidance generally pre-date the Internet. In practice, the FDA has liberally construed its statutory authority, asserting jurisdiction over some products that are not widely regarded by laypersons to be "medical devices." Specifically, the FDA has asserted jurisdiction over an E-meter (a polygraph-like device used by the Church of Scientology allegedly to cure disease) and a vinyl-covered bed with speakers mounted on the sides. FDA jurisdiction has also been successfully asserted over devices that are not part of a prelude to medical treatment.
For example, in United States v. Undetermined No. of Unlabelled Cases, 21 F.3d 1026 (10th Cir. 1994), the district court held that specimen containers used for HIV-testing constituted medical devices even though the testing was for insurance risk assessment and not for medical diagnosis, and even though the containers were used merely to contain and transport specimens from one location to another, had no medical application, and played no part in the protocol of diagnosis. The 10th Circuit upheld the district court's determination, concluding that the "plain meaning of 'diagnosis' disregards context and bears no connection to medical treatment." Specifically, the 10th Circuit held that the fact that "insurance companies rather than health professionals considered [the laboratory's] findings to make business rather than medical decisions did not erase the diagnostic character of [the laboratory's] activities or the containers' use."
Consistent with this expansive definition of "diagnosis," a few courts have also held that instruments used to test or screen for symptoms prior to formal identification of a condition or disease are "medical devices." See United States v. 25 Cases, 942 F.2d 1179 (7th Cir. 1991). At issue in 25 Cases were circular latex bags filled with a layer of silicone lubricant that were to be placed over a woman's breast during self-examinations to improve her ability to feel abnormalities beneath the skin. The manufacturer argued that its bags were used before actual diagnosis since they merely helped the woman in detecting abnormalities which may or may not be symptoms of a disease. The 7th Circuit rejected the manufacturer's distinction between screening and diagnosis as untenable, noting that the legislative history of the Act supported an interpretation of "diagnosis" that includes the "looking into a situation prior to the time when the cure or mitigation shall begin." Significantly, this case did not deal with more mundane devices such as heart monitors or blood pressure gauges, which have commonly been sold to consumers without prescription.
Some courts have also liberally construed what it means to "affect the structure or any function of the body," as part of the definition of "medical device." In United States v. Universal Management Services, Inc., 191 F.3d 750 (6th Cir. 1999), the 6th Circuit affirmed the district court in holding that devices that could send electrical currents into selected body parts were intended to affect the structure or function of the body, and thus were "devices" within the meaning of the Act. The electrical devices were marketed as pain relieving devices, designed to "stimulate excitatory cells which release electrical potentials which set off a chain of . reactions that send messages to the brain creating a responsive reaction that organizes peptides to return the body to homeostasis." After observing that pain is a function of the body, the court reasoned that intent to relieve pain is intent to affect that function. Once again, however, this case dealt with a more sophisticated and invasive diagnostic device than a consumer heart monitor, and, hence, may not provide guidance as to whether the FDA can or should regulate such simple monitoring devices.
Similarly, in United States v. 23, More or Less, Articles, 192 F.2d 308, (2d Cir. 1951), the Second Circuit held that a phonograph record designed to alleviate insomnia was a device within the meaning of the FDCA. The manufacturer guaranteed that the record would alleviate insomnia by inducing "blissful sleep" by the power of suggestion. Although the medical experts who testified at trial agreed that insomnia is not a disease, but a symptom of a disease, the court deemed this testimony irrelevant. The court stated that it is axiomatic that sleep is a function of the body and thus held that products designed to affect this function fall within the scope of the statute.While this is a very simplified glance at the FDCA, the import of the above regulatory scheme and the relevant case law can be seen.. First, it is unclear whether the FDA can or will attempt to exercise jurisdiction over the millions of health and fitness monitoring devices now being sold over the Internet. Second, practitioners would be well-advised to remember that the FDA has interpreted "device" in an expansive manner and the courts have given broad deference to the FDA's interpretation of the statute. Thus, the possibility exists that the FDA may successfully assert jurisdiction over these types of quasi-medical devices.
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