Opinion ID: 4436393
Heading Depth: 2
Heading Rank: 2

Heading: fda oversight of implanted

Text: MEDICAL DEVICES ¶14 Because the extent of the FDA’s oversight is significant to this analysis, we address the FDA’s regulation of medical devices. Before implanted medical devices like the ones made by Wright Medical may be marketed in the United States, the FDA categorizes 6 Cite as: 2019 UT 56 Opinion of the Court each device into one of three categories: Class I, II, or III, graded by their potential for causing serious injury. 3 See 21 U.S.C. § 360c(a)(1). ¶15 Class I devices are those that pose no unreasonable risk of illness or injury and are subject to only general control regulations.4 See id. § 360c(a)(1)(A). Class II devices are slightly more sophisticated devices that are regulated by special controls “necessary to provide adequate assurance of safety and effectiveness.” 5 Id. § 360c(a)(1)(B). ¶16 Unlike Class I and Class II devices, which present lesser risks, Class III devices include those that “present[] a potential unreasonable risk of illness or injury.” Id. § 360c(a)(1)(C)(ii)(II). These are devices “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.” 6 Id. § 360c(a)(1)(C)(ii)(I). ¶17 Because of the risk involved, all new Class III devices must undergo a process to provide “reasonable assurance” that the devices are effective and safe for medical use before they reach the market. Id. § 360c(a)(1)(C)(ii)(II). There are three methods of obtaining market approval for Class III devices. See id. § 360e. ¶18 The most rigorous is the premarket approval (PMA) process, which requires manufacturers to provide the FDA with comprehensive information about the device, including “full reports of all information, published or known to or which should reasonably be known to the applicant, concerning investigations which have been made to show whether or not [the] device is safe and effective.” Id. § 360e(c)(1)(A). The PMA process is focused on 3 These classifications were introduced in 1976 when Congress enacted the Medical Device Amendments (MDA), amending the Federal Food, Drug, and Cosmetic Act. 4 “Examples of Class I devices include stethoscopes, tongue depressors and ice packs.” Sasha B. Rieders, Note, State Law Tort Claims and the FDA: Proposing A Consumer-Oriented Prescription in Medical Device Cases, 25 CARDOZO L. REV. 1159, 1162 n.14 (2004). 5 Examples of Class II devices include oxygen masks, contraceptive devices, and tampons. Rieders, supra note 3, at 1162 n.14. 6Examples of Class III devices include pacemakers and prosthetic implants. Rieders, supra note 3, at 1162 n.16. 7 BURNINGHAM v. WRIGHT MEDICAL Opinion of the Court evaluating a device’s safety and efficacy. See id. This process “is a rigorous one.” Medtronic, Inc. v. Lohr, 518 U.S. 470, 477 (1996). After the manufacturers submit the required information, “the FDA then reviews [that information], spending an average of 1,200 hours on each submission.” Id. ¶19 In contrast, is a premarket notification process referred to as the “510(k) process.” 7 The 510(k) process allows a device to be cleared for market usage when the FDA determines that the device is “substantially equivalent” to a device already on the market. See 21 U.S.C. § 360e(b)(1)(B). This process allows manufacturers of devices that are substantially equivalent to devices already on the market to avoid the otherwise lengthy and costly PMA process. See id. § 360e(b)(1). ¶20 Notably, the FDA has not evaluated devices entering the market through the 510(k) process for safety and efficacy. The FDA’s substantial equivalence review is limited in scope, and the FDA considers “only whether the device is indeed the equivalent of a preexisting device—regardless of how unsafe or ineffective the grandfathered device happens to be.” Goodlin v. Medtronic, Inc., 167 F.3d 1367, 1369 n.1 (11th Cir. 1999) (citing Lohr, 518 U.S. at 478–80). Thus, the FDA does not “approve” devices entering the market through the substantial equivalence 510(k) process. 21 C.F.R. § 807.97 (“Any representation that creates an impression of official approval of a device because of complying with the [510(k)] premarket notification regulations is misleading and constitutes misbranding.”). Instead, the FDA “clears” devices entering the market through this path. 8 7 The term “510(k)” refers to the section number in the original Food, Drug, and Cosmetic Act. See Medtronic, Inc. v. Lohr, 518 U.S. 470, 478 (1996). United States Code section 360e and Code of Federal Regulations sections 807.81 through 807.100 contain the operative language of the 510(k) process. See generally 21 U.S.C. § 360e(b); 21 C.F.R. §§ 807.81–807.100. 8 See 510(k) Clearances, U.S. FOOD & DRUG ADMIN. (Sept. 4, 2018), https://www.fda.gov/MedicalDevices/ProductsandMedicalProced ures/DeviceApprovalsandClearances/510kClearances/default.htm referring to devices entering the market through the 510(k) process as “510(k) Clearances”). 8 Cite as: 2019 UT 56 Opinion of the Court ¶21 The new device does not need to be substantially equivalent to a device that passed the PMA process; rather, it is sufficient if the manufacturer can establish that the “marketed device to which a new device [is] compared . . . is a device that was legally marketed prior to May 28, 1976” (when the FDA implemented the present regulatory structure, the Medical Device Amendments (MDA)). Id. § 807.92(a)(3). As a result, a device that was grandfathered into legal marketability in 1976 can serve as the touchstone for future devices entering the market through the 510(k) process. See id. Additionally, new devices may receive 510(k) clearance by establishing substantial equivalence to a “device which has been found to be substantially equivalent through the 510(k) premarket notification process.” Id. Thus, the applicable regulations permit an unlimited line of products marching behind a grandfathered device, none of which has ever been subjected to the FDA’s scrutiny for safety or efficacy. ¶22 Furthermore, the 510(k) process relies on the manufacturer’s word. 9 The FDA is not involved in investigating the safety of the product undergoing the process. A finding of substantial equivalence and satisfaction of the 510(k) process “does not in any way denote official [FDA] approval of the device.” Id. § 807.97. 10 9 In the 510(k) process, manufacturers include in their application the following statement: I certify, in my capacity as (position held in company), of (company name), that I have conducted a reasonable search of all information known or otherwise available about the types and causes of safety or effectiveness problems that have been reported for the (type of device). I further certify that I am aware of the types of problems to which the (type of device) is susceptible and that, to the best of my knowledge, the following summary of the types and causes of safety or effectiveness problems about the (type of device) is complete and accurate. 21 C.F.R. § 807.94(a). 10 There is a third process, not implicated here, of gaining market approval by designating the device as innovative technology and marketing it under an “investigational device exemption” (IDE). See id. §§ 812.1–812.150. This method allows manufacturers to market a device before premarket approval “for the purpose of conducting (continued) 9 BURNINGHAM v. WRIGHT MEDICAL Opinion of the Court ¶23 The medical devices at issue in the federal case are Class III devices. Wright Medical used the 510(k) notification process to bring its hip implant devices to market, thus avoiding the PMA process. And the FDA cleared all of the devices at issue through the 510(k) process.