(a) We may disclose to the public any report, including any FDA record of a telephone report, submitted under this part. Our disclosures are governed by part 20 of this chapter.
(b) Before we disclose a report to the public, we will delete the following:
(1) Any information that constitutes trade secret or confidential commercial or financial information under § 20.61 of this chapter;
(2) Any personal, medical, and similar information, including the serial number of implanted devices, which would constitute an invasion of personal privacy under § 20.63 of this chapter. However, if a patient requests a report, we will disclose to that patient all the information in the report concerning that patient, as provided in § 20.61 of this chapter; and
(3) Any names and other identifying information of a third party that voluntarily submitted an adverse event report.
(c) We may not disclose the identity of a device user facility that makes a report under this part except in connection with:
(1) An action brought to enforce section 301(q) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 331(q)), including the failure or refusal to furnish material or information required by section 519 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360i));
(2) A communication to a manufacturer of a device that is the subject of a report required to be submitted by a user facility under § 803.30; or
(3) A disclosure to employees of the Department of Health and Human Services, to the Department of Justice, or to the duly authorized committees and subcommittees of the Congress.
Notes of Decisions
Cited in
19
cases (
3 in the last 5 years), 1992–2025 · leading case:
Aaron v. Medtronic, Inc., 209 F. Supp. 3d 994 (S.D. Ohio 2016).
Aaron v. Medtronic, Inc., 209 F. Supp. 3d 994 (S.D. Ohio 2016).
“21 C.F.R. § 803.9 (a) (emphasis added). Thus, adverse-event reports, unlike the warnings on a device label, “are not automatically made public.”
Conklin Et Ux v. Medtronic Inc, 431 P.3d 571 (Ariz. 2018).
“Third, and relatedly, when the FDA exercises its discretion to release adverse event reports publicly, it does so only passively by uploading the reports to a database.”
Glover v. Bausch & Lomb, Inc., 343 Conn. 513 (Conn. 2022).
· cites it 2× “21 C.F.R. § 803.9 (a) [2016] . . . . Thus, [adverse event] reports, unlike the warn- ings on a device label, are not automatically made pub- lic.”
Rosen v. St. Jude Med., Inc., 41 F. Supp. 3d 170 (N.D.N.Y. 2014).
“Defendants argue that Plaintiff has failed to show causation because: (1) Plaintiff has not demonstrated how Defendants’ alleged reporting violations actually caused her injury; (2) even if Defendants had properly reported adverse events, they would not necessarily have reached…”
Warstler v. Medtronic, Inc., 238 F. Supp. 3d 978 (N.D. Ohio 2017).
“21 C.F.R. § 803.9 (a) (emphasis added). Thus, adverse-event reports “are not automatically made public.”
Freed v. St. Jude Med., Inc., 364 F. Supp. 3d 343 (D. Del. 2019).
“Ohio 2016) (citing 21 C.F.R. § 803.9 (a) ) (emphasis in original) (certain quotation marks and citations omitted); see also, e.”
Rollins v. St. Jude Med., 583 F. Supp. 2d 790 (W.D. La. 2008).
“10 , The undersigned notes Rollins' cites 21 C.F.R. § 803.9 (c) for the proposition that a manufacturer is required to submit the following information in an individual adverse event report: (1) brand name; (2) type of device; (3) manufacturer name and address; (4) operator of…”
Pinsonneault v. St. Jude Med., Inc., 953 F. Supp. 2d 1006 (D. Minnesota 2013).
“” See 21 C.F.R. §§ 803.9 (a), 803.16. According to plaintiffs’ counsel’s representations at the hearing on the motions to amend, St.”
Marmol v. St. Jude Med. Ctr., 132 F. Supp. 3d 1359 (M.D. Fla. 2015).
“…of an MDR "is not necessarily an admission that the device ... caused or contributed to the reportable event.” 21 C.F.R. §§ 803.9 (a), 803.16.”
In Re Mentor Corp. ObTape Transobturator Sling Prods. Liab. Litig., 632 F. Supp. 2d 1370 (M.D. Ga. 2009).
“111 ; 21 C.F.R. § 803.9 (b)(3). Defendant contends that it must redact the names of the reporting physicians in this case pursuant to one of these regulations which provides, in part, The names and any information that would identify the voluntary reporter or any other perspn…”
Mirak v. McGhan Med. Corp., 142 F.R.D. 34 (D. Mass. 1992).
“With respect to the MDR’s, even if Command Trust testifies at hearing scheduled before the Food and Drug Administration, although redacted summaries of the MDR’s are available to Command Trust, or anyone else for that matter, under the Freedom of Information Act, see 21 C.F.R. §…”
— 21 C.F.R. § 803.9(a) — 1 case
Rosen v. St. Jude Med., Inc., 41 F. Supp. 3d 170 (N.D.N.Y. 2014).
“Defendants argue that Plaintiff has failed to show causation because: (1) Plaintiff has not demonstrated how Defendants’ alleged reporting violations actually caused her injury; (2) even if Defendants had properly reported adverse events, they would not necessarily have reached…”
Annotations are extracted automatically from the opinions in the
Syfert caselaw corpus and ranked by authority, recency, and
treatment. Dots show Syfertize treatment of the citing case itself.