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 E—Manufacturer Reporting Requirements

21 C.F.R. § 803.53

If I am a manufacturer, in which circumstances must I submit a 5-day report?

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You must submit a 5-day report to us with the information required by § 803.52 in accordance with the requirements of § 803.12(a) no later than 5 work days after the day that you become aware that:

(a) An MDR reportable event necessitates remedial action to prevent an unreasonable risk of substantial harm to the public health. You may become aware of the need for remedial action from any information, including any trend analysis or

(b) We have made a written request for the submission of a 5-day report. If you receive such a written request from us, you must submit, without further requests, a 5-day report for all subsequent events of the same nature that involve substantially similar devices for the time period specified in the written request. We may extend the time period stated in the original written request if we determine it is in the interest of the public health.

Notes of Decisions
Cited in 8 cases (1 in the last 5 years), 2006–2021 · leading case: Riegel v. Medtronic, Inc., 451 F.3d 104 (2d Cir. 2006).
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Riegel v. Medtronic, Inc., 451 F.3d 104 (2d Cir. 2006). · cites it 2× “21 C.F.R. § 803.53 . 11 the safety and effectiveness of the device.”
In Re Medtronic, Inc. Sprint Fidelis Leads Prods. Liab. Litig., 592 F. Supp. 2d 1147 (D. Minnesota 2009). “50 and 21 C.F.R. § 803.53 , regulations that were promulgated by the FDA in accordance with the FDCA.”
In re Smith & Nephew Birmingham Hip Resurfacing (BHR) Hip Implant Prods. Liab. Litig., 300 F. Supp. 3d 732 (D. Maryland 2018). “21 C.F.R. § 803.53 . The FDA may withdraw approval from a device if it determines, based on existing or new information, that "such device is unsafe or ineffective under the conditions of use prescribed, recommended, or suggested in the labeling thereof.”
Pinsonneault v. St. Jude Med., Inc., 953 F. Supp. 2d 1006 (D. Minnesota 2013). “50 was an attempt to enforce the MDA, ( 2011 WL 1485601 at *3), plaintiffs in this case rely on the same regulation relating to the MDR reporting requirements to support their failure-to-warn claim.”
Rowe v. Mentor Worldwide, LLC, 297 F. Supp. 3d 1288 (M.D. Fla. 2018). “52 ; 21 C.F.R. § 803.53 ; 21 C.F.R. § 803.56 ; 21 C.”
Gowin v. Smith & Nephew, Inc. (D. Maryland 2019). “50 , and to report these findings to the FDA within five days, 21 C.F.R. § 803.53 . If manufacturers want to make changes to a PMA approved device, they must submit an application for “supplemental premarket approval” to the FDA.”
Milanesi v. C.R. Bard, Inc. (S.D. Ohio 2021). “” 21 C.F.R. § 803.53 . This “adverse event information” includes any information that “reasonably suggests” that a manufacturer’s device “[m]ay have caused or contributed to a death or serious injury” or “[h] as malfunctioned and this device or a similar device that [they]…”
Gowin v. Smith & Nephew, Inc. (D. Maryland 2019). “50 , and to report these findings to the FDA within five days, 21 C.F.R. § 803.53 . If manufacturers want to make changes to a PMA approved device, they must submit an application for “supplemental premarket approval” to the FDA.”
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