(a) The holder of an approved PMA shall comply with the requirements of part 803 and with any other requirements applicable to the device by other regulations in this subchapter or by order approving the device.
(b) Unless FDA specifies otherwise, any periodic report shall:
(1) Identify changes described in § 814.39(a) and changes required to be reported to FDA under § 814.39(b).
(2) Contain a summary and bibliography of the following information not previously submitted as part of the PMA:
(i) Unpublished reports of data from any clinical investigations or nonclinical laboratory studies involving the device or related devices and known to or that reasonably should be known to the applicant.
(ii) Reports in the scientific literature concerning the device and known to or that reasonably should be known to the applicant. If, after reviewing the summary and bibliography, FDA concludes that the agency needs a copy of the unpublished or published reports, FDA will notify the applicant that copies of such reports shall be submitted.
(3) Identify changes made pursuant to an exception or alternative granted under § 801.128 or § 809.11 of this chapter.
(4) Identify each device identifier currently in use for the device, and each device identifier for the device that has been discontinued since the previous periodic report. It is not necessary to identify any device identifier discontinued prior to December 23, 2013.
[51 FR 26364, July 22, 1986, as amended at 51 FR 43344, Dec. 2, 1986; 67 FR 9587, Mar. 4, 2002; 72 FR 73602, Dec. 28, 2007; 78 FR 58822, Sept. 24, 2013]
Notes of Decisions
Riegel v. Medtronic, Inc., 451 F.3d 104 (2d Cir. 2006).
· cites it 7× “Additionally, the standard FDA “Conditions of Approval” accompanying a PMA order state that continued approval of the PMA “is contingent on the submission of postapproval reports required under 21 CFR 814.84 at intervals of 1 year from the date of approval of the original PMA.”
Riegel v. Medtronic, Inc., 552 U.S. 312 (2008).
· cites it 2× “These include the obligation to inform the FDA of new clinical investigations or scientific studies concerning the device which the applicant knows of or reasonably should know of, 21 CFR § 814.84 (b)(2), and to report incidents in which the device may have caused or contributed…”
Blunt v. Medtronic, Inc., 2009 WI 16 (Wis. 2009).
· cites it 4× “These include the obligation to inform the FDA of new clinical investigations or scientific studies concerning the device which the applicant knows of or reasonably should know of, 21 C.F.R. § 814.84 (b)(2), and to report incidents in which the device may have caused or…”
Elizabeth & Clifford Kemp v. Medtronic, Inc., 231 F.3d 216 (6th Cir. 2000).
· cites it 2× “Building on Count I, Count II alleges that Medtronic was required by the conditions of approval set forth in 21 C.F.R. § 814.84 to seek FDA approval for any change affecting the “safety and effectiveness of the device.”
Sherry Walker v. Medtronic, Inc., 670 F.3d 569 (4th Cir. 2012).
· cites it 2× “21 C.F.R. § 814.84 (b). "The FDA has the power to withdraw premarket approval based on newly reported data or existing information and must withdraw approval if it determines that a device is unsafe or ineffective under the conditions in its labeling.”
Waltenburg v. St. Jude Med., Inc., 33 F. Supp. 3d 818 (W.D. Ky. 2014).
· cites it 2× “§ 360i; 21 C.F.R. § 814.84 . These requirements include the obligation to submit periodic reports to the FDA informing the agency of any “[u]n-published reports of data from any clinical investigations or nonclinical laboratory studies involving the device” as well as any…”
White v. Stryker Corp., 818 F. Supp. 2d 1032 (W.D. Ky. 2011).
· cites it 2× “The standard FDA “Conditions of Approval” accompanying a PMA approval order state that continued approval of the PMA “is contingent on the submission of postapproval reports required under 21 C.F.R. 814.84 at intervals of 1 year from the date of approval of the original PMA.”
Ramirez v. Medtronic Inc., 961 F. Supp. 2d 977 (D. Ariz. 2013).
“For example, the manufacturer must update the FDA when it learns of investigations or scientific studies concerning its device, 21 C.F.R. § 814.84 (b)(2), or incidents where the device — used in any manner — “[m]ay have caused or contributed to a death or serious injury,” either…”
Clark v. Medtronic, Inc., 572 F. Supp. 2d 1090 (D. Minnesota 2008).
· cites it 2× “The manufacturer must also report the results of new scientific studies or investigations related to the safety or effectiveness of the device on an ongoing basis, 21 C.F.R. § 814.84 (b)(2), along with- any incidents where the device caused death or serious injury, or where it…”
Conklin Et Ux v. Medtronic Inc, 431 P.3d 571 (Ariz. 2018).
“(citing 21 C.F.R. § 814.84 (b)(2) ), "and to report incidents in which the device may have caused or contributed to death or serious injury[ ] or malfunctioned in a manner that would likely cause or contribute to death or serious injury if it recurred," id.”
McClelland v. Medtronic, Inc., 944 F. Supp. 2d 1193 (M.D. Fla. 2013).
· cites it 2× “Moreover, after PMA, manufacturers are subject to reporting requirements.”
Gelber v. Stryker Corp., 788 F. Supp. 2d 145 (S.D.N.Y. 2011).
“21 C.F.R. § 814.84 (b)(2). Manufacturers must also report incidents in which the device “[m]ay have caused or contributed to a death or serious injury” or “[h]as malfunctioned and this device or a similar device [marketed by the manufacturer] would be likely to cause or…”
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