Opinion ID: 172805
Heading Depth: 2
Heading Rank: 1

Heading: The Statutory and Regulatory System for Medical Device Reporting

Text: TMJ implants are medical devices within the meaning of 21 U.S.C. § 321(h). Through the Federal Food, Drug and Cosmetic Act, Congress empowered FDA to require every manufacturer of a medical device to establish and maintain such records, make such reports, and provide such information as the Secretary may by regulation reasonably require to assure that such device is not adulterated or misbranded and to otherwise assure its safety and effectiveness. 21 U.S.C. § 360i(a). Pursuant to this broad delegation of authority, Congress created an expansive reporting system under which FDA must require that every device manufacturer. . . [file an MDR] whenever the manufacturer. . . receives or otherwise becomes aware of information that reasonably suggests that one of its marketed devices may have caused or contributed to a death or serious injury. Id. § 360i(a)(1)(A). Congress clarified what types of events must be reported to FDA by defining a serious injury as one that is life threatening, results in permanent impairment of a body function or permanent damage to a body structure, or necessitates medical or surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure. Id. § 360i(a)(2)(A)(C). FDA has explained the purpose of the reporting requirement and its broad scope: To carry out its responsibilities, the agency needs to be informed whenever a manufacturer or importer receives or otherwise becomes aware of information about device problems. Only if FDA is provided with such information will it be able to evaluate the risk, if any, associated with a device and take whatever action is necessary to reduce or eliminate the public's exposure to this risk. 49 Fed.Reg. 36,326, 36,326 (Aug. 27, 1984). In response to public comments expressing concern that broad reporting requirements may impose unduly onerous burdens on medical device manufacturers, FDA reiterated the need for an expansive reporting system and adopted regulations that require manufacturers to file an MDR if they become aware of information suggesting that a device may have caused or contributed to a death or serious injury rather than the more limited language proposed that would have required manufacturers to file an MDR only in cases where they receive information suggesting that a device has caused or contributed to a death or serious injury. Id. at 36,331. FDA explained that the broader language was necessary because the agency needs to learn of instances in which there may be an association, as well as a causal connection, between the use of a device and a death or serious injury. Id. The implementing regulations to § 360i adopt the statutory definition of serious injury and define its crucial term permanent as irreversible impairment or damage to a body structure or function, excluding trivial impairment or damage. 21 C.F.R. § 803.3. The implementing regulations also define the phrase caused or contributed: Caused or contributed means that a . . . serious injury was or may have been attributed to a medical device, or that a medical device was or may have been a factor in a . . . serious injury, including events occurring as a result of: (1) Failure; (2) Malfunction; (3) Improper or inadequate design; (4) Manufacture; (5) Labeling; or (6) User error. [User] means a hospital, ambulatory surgical facility, nursing home, outpatient diagnostic facility, or outpatient treatment facility. . . . Id. Thus, focusing on the terms most relevant to this case, FDA mandates the filing of an MDR whenever the manufacturer of a medical device is aware of information that reasonably suggests its device (or an error on the part of the practitioner who or facility that implants or services the device) may have been a factor in the need to medically or surgically intervene in a particular individual's case, so long as the intervention is necessary to prevent irreversible, nontrivial impairment of a body function or irreversible, nontrivial damage to a body structure. The implementing regulations also describe when a manufacturer is not obligated to submit an MDR: when the manufacturer ha[s] information that would lead a person who is qualified to make a medical judgment reasonably to conclude that a device did not cause or contribute to a . . . serious injury. 21 C.F.R. § 803.20(c)(2). Put another way, if a qualified person rules out the device (or an error on the part of the practitioner who implants the device) as a factor in the need for medical or surgical intervention to prevent permanent harm to the body, and this conclusion is reasonable, then the manufacturer need not file an MDR. Particularly relevant to this case, however, is FDA's explanation that [n]owhere in . . . the act or its legislative history is FDA's authority limited to requiring only information about reportable events that have been confirmed by the manufacturer or importer of the device. 49 Fed.Reg. at 36,338. The submission of an MDR is not an admission that the device caused or contributed to the serious injury and a manufacturer may deny that its device caused the injury in their MDR. 21 C.F.R. § 803.16. Indeed, the standard form for the submission of an MDR includes a disclaimer to that effect. As part of this expansive reporting system, device manufacturers commonly receive information about their devices through FDA's MedWatch program. Under that program, any person may voluntarily report to FDA an adverse event or problem with a medical device. The voluntary MedWatch report form asks for the patient's name, a description of the event or problem, the name and manufacturer of the suspect device, and the name of the reporter. After FDA receives the report, the agency forwards it to the manufacturer identified on the report. If the reporter requests anonymity, however, regulations require FDA to redact any identifying information of the reporter before forwarding the report to the manufacturer. See id. § 20.63(f) (prohibiting FDA from disclosing any identifying information of a voluntary reporter). A manufacturer is responsible for investigating events described in MedWatch forms to evaluate the cause of the event and whether to submit an MDR for it. Id. § 803.50(b)(3). A manufacturer is not absolved of this duty when a MedWatch report contains incomplete or redacted information; in those circumstances, the manufacturer is required to file an incomplete report explaining why the report is incomplete and what steps the manufacturer has taken to obtain the relevant information. Id. Ultimately, the manufacturer is responsible for obtaining the relevant information to aid in its investigation and is required to supplement its report once it obtains such information. Id. § 803.50(b)(2), (3). Manufacturers must also maintain MDR event files that contain information regarding adverse events purportedly associated with their devices, including all documentation of the manufacturer's decisionmaking process used to determine whether the particular event is reportable. Id. § 803.18(b)(1)(i). Finally, manufacturers must permit FDA to access, copy, and verify its MDR files. Id. § 803.18(b)(2). Under 21 U.S.C. § 333(f)(1)(A), any person who violates [the MDR reporting requirements] shall be liable to the United States for a civil penalty. The penalty may not exceed $16,500 for each violation. 21 C.F.R. § 17.2. Liability for civil penalties requires proof that the violation was either a significant or knowing departure from the law, or that the violation posed a risk to public health. 21 U.S.C. § 333(f)(1)(B)(i).