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. § 807.81

When a premarket notification submission is required

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(a) Except as provided in paragraph (b) of this section, each person who is required to register his establishment pursuant to § 807.20 must submit a premarket notification submission to the Food and Drug Administration at least 90 days before he proposes to begin the introduction or delivery for introduction into interstate commerce for commercial distribution of a device intended for human use which meets any of the following criteria:

(1) The device is being introduced into commercial distribution for the first time; that is, the device is not of the same type as, or is not substantially equivalent to, (i) a device in commercial distribution before May 28, 1976, or (ii) a device introduced for commercial distribution after May 28, 1976, that has subsequently been reclassified into class I or II.

(2) The device is being introduced into commercial distribution for the first time by a person required to register, whether or not the device meets the criteria in paragraph (a)(1) of this section.

(3) The device is one that the person currently has in commercial distribution or is reintroducing into commercial distribution, but that is about to be significantly changed or modified in design, components, method of manufacture, or intended use. The following constitute significant changes or modifications that require a premarket notification:

(i) A change or modification in the device that could significantly affect the safety or effectiveness of the device, e.g., a significant change or modification in design, material, chemical composition, energy source, or manufacturing process.

(ii) A major change or modification in the intended use of the device.

(b)(1) A premarket notification under this subpart is not required for a device for which:

(i) A premarket approval application under section 515 of the act, or for which a petition to reclassify under section 513(f)(2) of the act, is pending before the Food and Drug Administration, or

(ii) There is a predetermined change control plan (PCCP) cleared under section 515C of the act, provided that the change is consistent with the PCCP.

(2) The appropriate FDA Center Director may determine that the submission and grant of a written request for an exception or alternative under § 801.128 or § 809.11 of this chapter satisfies the requirement in paragraph (a)(3) of this section.

(c) In addition to complying with the requirements of this part, owners or operators of device establishments that manufacture radiation-emitting electronic products, as defined in § 1000.3 of this chapter, shall comply with the reporting requirements of part 1002 of this chapter.

[42 FR 42526, Aug. 23, 1977, as amended at 72 FR 73601, Dec. 28, 2007; 89 FR 18792, Mar. 15, 2024]
Notes of Decisions
Cited in 49 cases (7 in the last 5 years), 1985–2023 · 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. § 807.81 (a); see also id. § 807.”
Riegel v. Medtronic, Inc., 451 F.3d 104 (2d Cir. 2006). · cites it 3× “” 21 C.F.R. § 807.81 (3)(i)-(ii) (emphasis added).”
United States v. Caputo, 288 F. Supp. 2d 912 (N.D. Ill. 2003). · cites it 6× “) In particular they assert that 21 C.F.R. § 807.81 is unconstitutionally vague.”
PhotoMedex, Inc. v. Irwin, 601 F.3d 919 (9th Cir. 2010). · cites it 3× “” 21 C.F.R. § 807.81 (a)(3). 4 An FDA guideline *926 document makes clear that responsibility is placed on the manufacturer to decide whether device changes necessitate a new 510(k) submission.”
Barbara E. Horn, of the Est. of Daniel Ray Horn, Deceased v. Thoratec Corp., 376 F.3d 163 (3rd Cir. 2004). · cites it 2× “Moreover, the range of changes that a manufacturer can make to a [§ 510(k) ] cleared device without getting prior authority from FDA is broader than for a[PMA] approved device.”
United States v. Facteau, 89 F.4th 1 (1st Cir. 2023). · cites it 4× “21 C.F.R. § 807.81 (a). This premarket notification submission includes a "510(k) summary" identifying the predicate device and describing the device submitted for clearance, including its "intended use.”
United States v. Caputo, 313 F. Supp. 2d 764 (N.D. Ill. 2004). · cites it 7× “” 21 C.F.R. § 807.81 (a)(3). 2 The FDA granted Abtox premarket clearance to market the Plazlyte sterilizer after determining that it was substantially equivalent to ethylene oxide sterilizers that were already on the market.”
United States v. Caputo, 517 F.3d 935 (7th Cir. 2008). · cites it 2× “The line between a “modification” (no approval needed) and a new device (which must be submitted independently for approval) is drawn in 21 C.F.R. § 807.81 . There are two principal inquiries: first, whether the changes “significantly affect the safety or effectiveness of the…”
Forman v. Meridian Bioscience, Inc., 387 F. Supp. 3d 791 (S.D. Ohio 2019). · cites it 2× “Nonetheless, Meridian recklessly and misleadingly stated in its November 2016 Form 10-K that all of its products, including all of the LeadCare products, were "cleared by the FDA.”
North Am. Med. Corp. v. Axiom Worldwide, Inc., 522 F.3d 1211 (11th Cir. 2008). “Compare 21 C.F.R. § 807.81 (a)(1) (2006), with 21 C.”
Kapps v. Biosense Webster, Inc., 813 F. Supp. 2d 1128 (D. Minnesota 2011). · cites it 2× “Under 21 C.F.R. § 807.81 , a new 510(k) application is required when a manufacturer makes “[a] change or modification in [a previously approved] device that could significantly affect the safety or effectiveness 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.”
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