Preemption and Medical Devices
Regulation of Medical Devices
As with pharmaceutical litigation, and understanding of the central statutes and regulations governing medical devices is an essential element to understanding the preemption issues surrounding medical device litigation, and relatedly, the causes of action available to plaintiffs in medical device cases. Medical devices have been regulated since the Food, Drug and Cosmetic Act of 1938. But since the FDA lacked the authority to vet medical devices before they went on the market, FDA regulation of devices prior to 1976 was limited to after-the-fact regulation through enforcement of the Act’s misbranding and adulteration provisions. There was perhaps little need for comprehensive legislation that proactively regulated devices at the time, however, as it was drugs, not devices, that were ubiquitous. This changed in the 1960s and 1970, when medical devices (both the legitimate and the seemingly legitimate but not) began to figure prominently in medical care.[1] This changed with the passage of the Medical Device Amendments of 1976, which established the current framework for approval and regulation of devices in the United States.
Device Classes
Under the Food, Drug, and Cosmetic Act, a “device” is defined as “an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory” that is “intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease” “which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of its primary intended purposes.”[2]
Medical devices are divided into three separate classes: Class I (general controls), Class II (special controls), and Class III (premarket approval).
Class I
Class I devices receive the lowest level of regulatory scrutiny. They are devices for which general controls “are sufficient to provide reasonable assurance of the safety and effectiveness of the device.”[3] General controls include such things as establishment registration, device listing, premarket notification, and good manufacturing practices requirements. Because these devices are viewed as low-risk, they do not go through the premarket review process, and manufacturers are not required to apply for approval prior to selling them.
Even if there is insufficient information to determine whether the general controls are sufficient to ensure safety and effectiveness, and device may nevertheless be classified as Class I if it (1) is not used in “supporting or sustaining human life or . . . of substantial importance in preventing impairment of human health, and (2) “does not present a potential unreasonable risk of illness or injury.”[4]
Class I devices include things like Band-Aids and bedpans.
Class II
Class II devices are those that “cannot be classified as class I because the general controls by themselves are insufficient to provide reasonable assurance of safety and effectiveness of the device,” but “for which there is sufficient information to establish special controls to provide such assurance.”[5] Such special controls might take the form of performance standards, postmarket surveillance, or labeling requirements such as guidelines and recommendations for use.[6]
Class III
The third and final category of medical devices are Class III devices. They are devices that “cannot be classified as a class I device because insufficient information exists to determine that the application of general controls are sufficient to provide reasonable assurance of the safety and effectiveness of the device,” and “cannot be classified as a class II device because insufficient information exists to determine that the special controls . . . would provide reasonable assurance of [their] safety and effectiveness,” and are “purported or represented to be for a use in supporting or sustaining human life or for a use which is of substantial importance in preventing impairment of human health,” or present “a potential unreasonable risk of illness or injury, [are] to be subject . . . to premarket approval to provide reasonable assurance of [their] safety and effectiveness.”
There was a significant exception to this regulatory structure for devices that were on the market prior to 1976. Pacemakers, defibrillators, and artificial heart valves that would not receive regulatory approval today were able to stay on the market, and several of these devices spawned significant mass tort litigation.
The second significant exception to this regulatory scheme is Class III devices that are “substantially equivalent” to a device that has already received FDA approval.
Device Regulation
There are two very different paths by which the FDA approves most moderate- and high-risk (Class II and III?) devices: 510(k) notification and premarket approval. The terminology is suggestive of the main distinction between the two processes. Under 510(k), the manufacturer notifies the FDA that a device will be marketed and sold, whereas the premarket approval process is much more involved (and expensive.
The FDCA requires all device manufacturers to (1) register their facilities; (2) list their devices; and (3) follow general control requirements.
In 2015, the FDA approved 98% of premarket-approval devices and 85% of 510(k) devices.[7]
First, a note about terminology. 510(k) devices are so named because the premarket notification process through which such devices come to the market was contained in section 510 of the Food, Drug and Cosmetic Act. But the premarket notification provisions for 510(k) devices are codified at 21 U.S.C. 360. But the provisions for devices that must receive FDA approval before they can be sold (premarket approval or “PMA” devices) are codified at 21 U.S.C. § 360e.
510(k) Clearance
The essential element of the 510(k) clearance process (also called 510(k) notification) is the presence of a predicate, substantially equivalent device.
Premarket Approval
If a device is not eligible for 510(k) notification, it must go through a much more extensive (and expensive) approval process before it can be sold.[8]
A premarket approval application usually involves clinical data, meaning the device must be used in a preliminary, investigational phase. To use a device during clinical trials, the evaluator will (with a few exceptions) require an investigational device exemption (“IDE”).[9]
Even after a device is approved, the FDA may order post-approval studies. However, it is important to note that “the FDA has never issued a warning letter to a manufacturer for failing to start or complete a mandated PAS [post-approval study].”[10]
[1] See James T. O’Reilly & Katherine A. Van Tassel, 1 Food and Drug Administration § 3.8 (4th ed. 2018).
[2] 21 U.S.C. § 321(h)(1). Note that this definition tracks the definition of “drug,” but through contrast to what is a drug (the so-called “mode of action” distinction—whether the drug or device achieves its primary effect through chemical action. Notably, in making the distinction between drugs and devices, the “FDA has administratively developed a distinction . . . which favors classifying a product as a drug if its intended action is chemical, or based on highly complex technology, potential hazards of which may be reduced through new drug controls.” S. Rep. No. 94-33, at 6 (1975), reprinted in 1976 U.S.C.C.A.N. 1070, 1075. See also Genus Medical Technologies LLC v. United States Food and Drug Administration, 994 F.3d 631, 641–42 (D.C. Cir. 2021) (quoting S. Rep. No. 94-33).
[3] 21 C.F.R. § 820.
[4] 21 U.S.C. § 360c(a)(1)(A)(ii).
[5] 21 U.S.C. § 360c(a)(1)(B).
[6] 21 U.S.C. § 360c(a)(1)(B).
[7] Judith A. Johnson, FDA Regulation of Medical Devices i (Congressional Research Service 2016).
[8] As one treatise observes in discussing the FDA Safety and Innovation Act Amendments of 2012, Pub. L. No. 112-144, 126 Stat. 993:
The paradigmatic impact was on medical device clearance procedural changes. With a remarkable expenditure of energy, medical device manufacturers were able to totally disarm the FDA efforts and the Institute of Medicine proposals for altering the premarket process. The resulting absence of change means that the FDA clearance process followed since 1997 will remain in full effect.
James T. O’Reilly & Katherine A. Van Tassel, 1 Food and Drug Administration § 3.14 (4th ed. 2018).
[9] 21 C.F.R. § 812.
[10] Ian S. Reynolds et al., Assessing the Safety and Effectiveness of Devices After US Food and Drug Administration Approval: FDA-Mandated Postapproval Studies, 174 JAMA Internal Medicine 1773, [pincite] (Nov. 2014). [still accurate?]