(a) If you are a manufacturer, you must report to us the information required by § 803.52 in accordance with the requirements of § 803.12(a), no later than 30 calendar days after the day that you receive or otherwise become aware of information, from any source, that reasonably suggests that a device that you market:
(1) May have caused or contributed to a death or serious injury or
(2) Has malfunctioned and this device or a similar device that you market would be likely to cause or contribute to a death or serious injury, if the malfunction were to recur.
(b) What information does FDA consider “reasonably known” to me?
(1) You must submit all information required in this subpart E that is reasonably known to you. We consider the following information to be reasonably known to you:
(i) Any information that you can obtain by contacting a user facility, importer, or other initial reporter;
(ii) Any information in your possession; or
(iii) Any information that you can obtain by analysis, testing, or other evaluation of the device.
(2) You are responsible for obtaining and submitting to us information that is incomplete or missing from reports submitted by user facilities, importers, and other initial reporters.
(3) You are also responsible for conducting an investigation of each event and evaluating the cause of the event. If you cannot submit complete information on a report, you must provide a statement explaining why this information was incomplete and the steps you took to obtain the information. If you later obtain any required information that was not available at the time you filed your initial report, you must submit this information in a supplemental report under § 803.56 in accordance with the requirements of § 803.12(a).
Notes of Decisions
Hughes v. Boston Sci. Corp., 631 F.3d 762 (5th Cir. 2011).
· cites it 3× “§ 360i(a)(l); 21 C.F.R. § 803.50 (a). The FDA may approve marketing of the Class III device subject to additional postapproval conditions, which the FDA may include in its PMA approval order.”
Dennis Godelia v. Zoll Servs., LLC, 881 F.3d 1309 (11th Cir. 2018).
· cites it 2× “20(c)”; (5) "Failure to report to us no later than 30 calendar days after the day that your firm received or otherwise became aware of information, from any source, that reasonably suggests that a device that your firm markets may have caused or contributed to a death or serious…”
Rosen v. St. Jude Med., Inc., 41 F. Supp. 3d 170 (N.D.N.Y. 2014).
· cites it 4× “Following the inspection, the FDA’s review revealed that “in some cases Defendants failed to submit MDR reports containing all information reasonably known to them in accordance with the provisions of 21 C.F.R. § 803.50 (b).” Id. ¶ 56 . “Specifically, the complaint files show…”
Riegel v. Medtronic, Inc., 451 F.3d 104 (2d Cir. 2006).
· cites it 2× “” 21 C.F.R. § 803.50 . In the event that a manufacturer learns that a reportable event “necessitates remedial action to prevent an unreasonable risk of substantial harm to the public health,” it is required to submit a report to the FDA within five days.”
Barone v. Bausch & Lomb, Inc., 372 F. Supp. 3d 141 (W.D.N.Y. 2019).
· cites it 3× “As a result, B & L "violated 21 C.F.R. § 803.50 (a) and the conditions set by the FDA's initial approval for the Crystalens.”
In Re Medtronic, Inc. Sprint Fidelis Leads Prods. Liab. Litig., 592 F. Supp. 2d 1147 (D. Minnesota 2009).
· cites it 2× “See 21 C.F.R. §§ 803.50 , 803.53. II. The FDCA’s express preemption clause In response to a bevy of state laws regulating medical devices largely enacted due to the failure of the Daikon Shield contraceptive in the 1970s, Congress passed the Medical Device Amendments to the FDCA…”
Gravitt v. Mentor Worldwide, LLC, 289 F. Supp. 3d 877 (E.D. Ill. 2018).
· cites it 3× “at ¶ 24 (citing, among other regulations, 21 C.F.R. §§ 803.50 , 814, 820.20, 820.198, 820.”
Joseph Mink v. Smith & Nephew, Inc., 860 F.3d 1319 (11th Cir. 2017).
“§ 360i; 21 C.F.R. §§ 803.50 (a), 814.84(b)(2). The Medical Device Amendments contain, among other things, two provisions that are central to this appeal.”
Ramirez v. Medtronic Inc., 961 F. Supp. 2d 977 (D. Ariz. 2013).
· cites it 2× “” 21 C.F.R. § 803.50 (a). Manufacturers must provide these reports ostensibly for all uses of a product, and therefore a manufacturer who learns of an adverse event that resulted from an off-label use must report that event to the FDA.”
Coleman v. Medtronic, Inc., 223 Cal. App. 4th 413 (Cal. Ct. App. 2014).
· cites it 2× “( 21 C.F.R. § 803.50 (a) (2013).) Applicants must also report new clinical investigations or scientific studies concerning the device of which the applicant knows or reasonably should have known.”
— 21 C.F.R. § 803.50(a) — 2 cases
— 21 C.F.R. § 803.50(a)(1) — 1 case
Dennis Godelia v. Zoll Servs., LLC, 881 F.3d 1309 (11th Cir. 2018).
“20(c)”; (5) "Failure to report to us no later than 30 calendar days after the day that your firm received or otherwise became aware of information, from any source, that reasonably suggests that a device that your firm markets may have caused or contributed to a death or serious…”
— 21 C.F.R. § 803.50(a)(2) — 1 case
Dennis Godelia v. Zoll Servs., LLC, 881 F.3d 1309 (11th Cir. 2018).
“20(c)”; (5) "Failure to report to us no later than 30 calendar days after the day that your firm received or otherwise became aware of information, from any source, that reasonably suggests that a device that your firm markets may have caused or contributed to a death or serious…”
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