C.F.R. » Title 21 » CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES › SUBCHAPTER H—MEDICAL DEVICES › PART 807—ESTABLISHMENT REGISTRATION AND DEVICE LISTING FOR MANUFACTURERS AND INITIAL IMPORTERS OF DEVICES › Subpart E—Premarket Notification Procedures

21 C.F.R. § 807.97

Misbranding by reference to premarket notification

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Submission of a premarket notification in accordance with this subpart, and a subsequent determination by the Commissioner that the device intended for introduction into commercial distribution is substantially equivalent to a device in commercial distribution before May 28, 1976, or is substantially equivalent to a device introduced into commercial distribution after May 28, 1976, that has subsequently been reclassified into class I or II, does not in any way denote official approval of the device. Any representation that creates an impression of official approval of a device because of complying with the premarket notification regulations is misleading and constitutes misbranding.

Notes of Decisions
Cited in 46 cases (9 in the last 5 years), 1992–2023 · leading case: Barbara Kaiser v. Johnson & Johnson, 947 F.3d 996 (7th Cir. 2020).
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Barbara Kaiser v. Johnson & Johnson, 947 F.3d 996 (7th Cir. 2020). · cites it 2× “See 21 C.F.R. § 807.97 . Prolift’s clearance also contains several red flags.”
Riegel v. Medtronic, Inc., 451 F.3d 104 (2d Cir. 2006). · cites it 2× “” 21 C.F.R. § 807.97 (emphasis added). Once a device has entered the market pursuant to the § 510(k) process, its manufacturer has broader latitude to make changes on its own than does the manufacturer of a PMA-approved device.”
Christopher v. Depuy Orthopaedics, Inc. (In Re Depuy Orthopaedics, Inc., Pinnacle Hip Implant Prod. Liab. Litig.), 888 F.3d 753 (5th Cir. 2018). “" 21 C.F.R. § 807.97 . The process "provide[s] little protection to the public" because it is "focused on equivalence , not safety.”
Steele v. Collagen Corp., 54 Cal. App. 4th 1474 (Cal. Ct. App. 1997). · cites it 4× “" ( 21 C.F.R. § 807.97 (1996).) "[The] explicit statement [contained in 21 C.”
Ellen Mendes v. Medtronic, Inc., 18 F.3d 13 (1st Cir. 1994). “”); 21 C.F.R. § 807.97 (a finding of substantial equivalence “does not in any way denote official approval of the device”).”
PhotoMedex, Inc. v. Irwin, 601 F.3d 919 (9th Cir. 2010). “” 21 C.F.R. § 807.97 . PhotoMedex does not argue that Defendants’ “FDA approved” statement is in itself false or misleading on the ground that the FDA does not “approve” Class II devices in the way that it reviews and provides premarket approval of Class III devices, as…”
Jennifer Stamps v. Collagen Corp., 984 F.2d 1416 (5th Cir. 1993). “6305, 6307; 21 C.F.R. § 807.97 (FDA’s acceptance of claim of substantial equivalence does not denote official approval of the device)).”
Larsen v. Pacesetter Sys., Inc., 837 P.2d 1273 (Haw. 1992). “See also 21 C.F.R. § 807.97 (FDA’s acceptance of claim of substantial equivalence does not in any way denote official approval of the device).”
United States ex rel. Nowak v. Medtronic, Inc., 806 F. Supp. 2d 310 (D. Mass. 2011). “5 ; 21 C.F.R. § 807.97 . These limited indications must be listed on the label, and a manufacturer may only promote a device for cleared or approved indications.”
Lewis v. Johnson & Johnson, 991 F. Supp. 2d 748 (S.D. W. Va. 2014). “(“Any representation that creates an impression of official approval of a device because of complying with the premarket notification regulations is misleading and constitutes misbranding.”
Booker v. C. R. Bard, Inc. (In re Bard IVC Filters Prods. Liab. Litig.), 289 F. Supp. 3d 1045 (D. Ariz. 2018). “]" 21 C.F.R. § 807.97 . Plaintiffs certainly will be free to present evidence and argument that the 510(k) process is a comparative one that requires only substantial equivalence to a predicate device, that 510(k) regulations are not safety regulations, and-as Plaintiffs…”
Natalie Johnson v. C. R. Bard, Inc., 77 F.4th 641 (7th Cir. 2023). “(quoting 21 C.F.R. § 807.97 ). In Kaiser, we held that the defendants were not entitled to the Indiana presumption of non-defectiveness because there was no assurance that product safety had factored into the FDA’s clearance decision, which was based on the substan-…”
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