C.F.R. » Title 21 » CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES › SUBCHAPTER H—MEDICAL DEVICES › PART 803—MEDICAL DEVICE REPORTING › Subpart A—General Provisions

21 C.F.R. § 803.10

Generally, what are the reporting requirements that apply to me?

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(a) If you are a device user facility, you must submit reports (described in subpart C of this part), as follows:

(1) Submit reports of individual adverse events no later than 10 work days after the day that you become aware of a reportable event:

(i) Submit reports of device-related deaths to us and to the manufacturer, if known, or

(ii) Submit reports of device-related serious injuries to the manufacturers or, if the manufacturer is unknown, submit reports to us.

(2) Submit annual reports (described in § 803.33) to us.

(b) If you are an importer, you must submit reports (described in subpart D of this part), as follows:

(1) Submit reports of individual adverse events no later than 30 calendar days after the day that you become aware of a reportable event:

(i) Submit reports of device-related deaths or serious injuries to us and to the manufacturer or

(ii) Submit reports of device-related malfunctions to the manufacturer.

(2) [Reserved]

(c) If you are a manufacturer, you must submit reports (described in subpart E of this part) to us, as follows:

(1) Submit reports of individual adverse events no later than 30 calendar days after the day that you become aware of a reportable death, serious injury, or malfunction.

(2) Submit reports of individual adverse events no later than 5 work days after the day that you become aware of:

(i) A reportable event that requires remedial action to prevent an unreasonable risk of substantial harm to the public health or

(ii) A reportable event for which we made a written request.

(3) Submit supplemental reports if you obtain information that you did not submit in an initial report.

Notes of Decisions
Cited in 14 cases (7 in the last 5 years), 2005–2023 · leading case: Jack McMullen and Barbara McMullen v. Medtronic, Inc.
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Jack McMullen and Barbara McMullen v. Medtronic, Inc. (2005) ca7 “§ 360i; 21 C.F.R. §§ 803.10 (c), 803.50. If Medtronic believed that a warning different from the one approved by the FDA was appropriate in light of an adverse event, it was required to seek FDA approval of any proposed changes.”
In Re Bausch & Lomb, Inc. Securities Litigation (2008) nywd “See 21 C.F.R. § 803.10 . 13 After conducting research on the identified lots, B & L informed HKDH in a letter that it had reviewed its manufacturing batch records and found nothing unusual, and that it had tested retained samples from the identified lots and discovered that they…”
Rowe v. Mentor Worldwide, LLC (2018) flmd “Admittedly, it is unclear if Rowe intended to allege this theory of liability given that the allegations are out of order. But the Court addresses it in an abundance of caution.”
Cline v. Advanced Neuromodulation Systems, Inc. (2014) gand “Indeed, Plaintiffs allegations do not explain if or how the FDA would disclose Defendant’s MDRs detailing internal reviews and revisions to the Model 3788 manufacturing process.”
Funke v. Sorin Group USA, Inc. (2015) cacd “) Sorin counters that the Valve first received pre-market approval in the United States on October 23, 2007, and that its post-market approval reporting obligations did not commence until that date.”
Howmedica Osteonics Corp. v. Trowbridge (2017) fladistctapp “50 (a); see also 21 C.F.R. § 803.10 (c). By contrast, voluntary reporters are physicians, consumers, or others who voluntarily report adverse events associated with medical devices to the FDA and manufacturers.”
(PS) Nichols v. Mentor Worldwide LLC (2021) caed “” 21 C.F.R. § 803.10 ; Stengel, 704 F.3d at 1226–27.”
(PS)Kline v. Mentor Worldwide LLC (2021) caed “” 21 C.F.R. § 803.10 ; Stengel, 704 F.3d at 1226–27.”
Redick v. Smith & Nephew, Inc. (2021) mdd “Under 21 C.F.R. § 803.10 (c), medical device manufacturers are obligated to submit MDRs to the FDA.”
Higgins v. Boston Scientific Corporation (2021) mnd “21 C.F.R. § 803.10 (c)(2)(i). Relator argues that BSC’s failure to report any setscrew/header issues as five-day MDRs was a material regulatory violation.”
Garcia v. Bayer Essure, Inc. (2022) nmd “ECF No. 15 at 5, 9. Plaintiff contends that “[g]eneral common law negligence claims imposed by a state regarding failure to provide adequate warnings on medical device manufacturers have consistently been held not expressly or impliedly preempted by the MDA because they are…”
Garcia v. Bayer Essure, Inc. (2023) nmd “at 7 (citing 21 C.F.R. §§ 803.10 ; 803.50; 803.52; 803.”
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