(a) This part establishes the requirements for medical device reporting for device user facilities, manufacturers, importers, and distributors. If you are a device user facility, you must report deaths and serious injuries that a device has or may have caused or contributed to, establish and maintain adverse event files, and submit summary annual reports. If you are a manufacturer or importer, you must report deaths and serious injuries that your device has or may have caused or contributed to, you must report certain device malfunctions, and you must establish and maintain adverse event files. If you are a manufacturer, you must also submit specified followup. These reports help us to protect the public health by helping to ensure that devices are not adulterated or misbranded and are safe and effective for their intended use. If you are a medical device distributor, you must maintain records (files) of incidents, but you are not required to report these incidents.
(b) This part supplements and does not supersede other provisions of this chapter, including the provisions of part 820 of this chapter.
(c) References in this part to regulatory sections of the Code of Federal Regulations are to chapter I of title 21, unless otherwise noted.
Notes of Decisions
Lori Nicholson v. Biomet, Inc., 46 F.4th 757 (8th Cir. 2022).
“8, 2022); see also 21 C.F.R. § 803.1 (a) (establishing requirements for medical device reporting).”
Worthy v. Collagen Corp., 967 S.W.2d 360 (Tex. 1998).
“21 C.F.R. § 803.1 (1997). The FDA is authorized to notify the public of risks presented by medical devices, 21 U.”
Silver v. Medtronic, Inc., 236 F. Supp. 3d 889 (M.D. Penn. 2017).
“” 21 C.F.R. § 803.1 ; (Doc. 1, ¶¶ 78-80). Thus, the claim does not seek to impose additional warning requirements on Medtronic and would not be expressly preempted.”
Rollins v. St. Jude Med., 583 F. Supp. 2d 790 (W.D. La. 2008).
“Also, 21 C.F.R. § 803.1 (a) requires manufacturers to "report deaths and serious injuries that [the manufacturer's] device may have caused or contributed to, .”
Armstrong v. Optical Radiation Corp., 30 U.C.C. Rep. Serv. 2d (West) 1084 (Cal. Ct. App. 1996).
“” (See 21 C.F.R. § 803.1 (a) (1995) [requiring report to FDA if “one of [the manufacturer’s] marketed devices (1) may have caused or contributed to a death or serious injury or (2) has malfunctioned and that the device .”
Angeles v. Medtronic, Inc., 863 N.W.2d 404 (Minn. Ct. App. 2015).
“See 21 C.F.R. § 803.1 -.58 (2014). Manufacturers must report specific adverse consequences, a summary of “[unpublished reports of data from any clinical investigation or nonclinical laboratory studies involving the device or related devices and known to or that reasonably should…”
United States v. Laerdal Mfg. Corp., 853 F. Supp. 1219 (D. Or. 1994).
· cites it 2× “21 C.F.R. § 803.1 (a). Under the MDR regulations, the manufacturer of a medical device who receives information that reasonably suggests that the device may have caused or contributed to a death or serious injury is required to notify the FDA by telephone within five calendar…”
Steele v. Depuy Orthopaedics, Inc., 295 F. Supp. 2d 439 (D.N.J. 2003).
“39 ; see also 21 C.F.R. § 803.1 (requiring manufacturer to report “deaths and serious injuries” related to the operation of the device, to “maintain adverse event files,” and to submit to FDA “specified followup and summary reports”).”
Parkinson v. Guidant Corp., 315 F. Supp. 2d 754 (W.D. Pa. 2004).
“…medical devices to complete whenever there is a medical device related event that could involve patient consequences. 21 C.F.R. § 803.1 .”
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