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. § 807.87

Information required in a premarket notification submission

Read at: eCFRecfr.gov CornellLII GovInfogovinfo.gov CasesGoogle Scholar

Each premarket notification submission shall contain the following information:

(a) The device name, including both the trade or proprietary name and the common or usual name or classification name of the device.

(b) The establishment registration number, if applicable, of the owner or operator submitting the premarket notification submission.

(c) The class in which the device has been put under section 513 of the act and, if known, its appropriate panel; or, if the owner or operator determines that the device has not been classified under such section, a statement of that determination and the basis for the person's determination that the device is not so classified.

(d) Action taken by the person required to register to comply with the requirements of the act under section 514 for performance standards.

(e) Proposed labels, labeling, and advertisements sufficient to describe the device, its intended use, and the directions for its use. Where applicable, photographs or engineering drawings should be supplied.

(f) A statement indicating the device is similar to and/or different from other products of comparable type in commercial distribution, accompanied by data to support the statement. This information may include an identification of similar products, materials, design considerations, energy expected to be used or delivered by the device, and a description of the operational principles of the device.

(g) Where a person required to register intends to introduce into commercial distribution a device that has undergone a significant change or modification that could significantly affect the safety or effectiveness of the device, or the device is to be marketed for a new or different indication for use, the premarket notification submission must include appropriate supporting data to show that the manufacturer has considered what consequences and effects the change or modification or new use might have on the safety and effectiveness of the device.

(h) A 510(k) summary as described in § 807.92 or a 510(k) statement as described in § 807.93.

(i) A financial certification or disclosure statement or both, as required by part 54 of this chapter.

(j) For a submission supported by clinical data:

(1) If the data are from clinical investigations conducted in the United States, a statement that each investigation was conducted in compliance with applicable requirements in the protection of human subjects regulations in part 50 of this chapter, the institutional review boards regulations in part 56 of this chapter, or was not subject to the regulations under § 56.104 or § 56.105, and the investigational device exemptions regulations in part 812 of this chapter, or if the investigation was not conducted in compliance with those regulations, a brief statement of the reason for the noncompliance.

(2) If the data are from clinical investigations conducted outside the United States, the requirements under § 812.28 of this chapter apply. If any such investigation was not conducted in accordance with good clinical practice (GCP) as described in § 812.28(a) of this chapter, include either a waiver request in accordance with § 812.28(c) of the chapter or a brief statement of the reason for not conducting the investigation in accordance with GCP and a description of steps taken to ensure that the data and results are credible and accurate and that the rights, safety, and well-being of subjects have been adequately protected.

(k) For submissions claiming substantial equivalence to a device which has been classified into class III under section 513(b) of the act:

(1) Which was introduced or delivered for introduction into interstate commerce for commercial distribution before December 1, 1990; and

(2) For which no final regulation requiring premarket approval has been issued under section 515(b) of the act, a summary of the types of safety and effectiveness problems associated with the type of devices being compared and a citation to the information upon which the summary is based (class III summary). The 510(k) submitter shall also certify that a reasonable search of all information known or otherwise available about the class III device and other similar legally marketed devices has been conducted (class III certification), as described in § 807.94. This information does not refer to information that already has been submitted to the Food and Drug Administration (FDA) under section 519 of the act. FDA may require the submission of the adverse safety and effectiveness data described in the class III summary or citation.

(l) A statement that the submitter believes, to the best of his or her knowledge, that all data and information submitted in the premarket notification are truthful and accurate and that no material fact has been omitted.

(m) Any additional information regarding the device requested by the Commissioner that is necessary for the Commissioner to make a finding as to whether or not the device is substantially equivalent to a device in commercial distribution. A request for additional information will advise the owner or operator that there is insufficient information contained in the original premarket notification submission for the Commissioner to make this determination and that the owner or operator may either submit the requested data or a new premarket notification containing the requested information at least 90 days before the owner or operator intends to market the device, or submit a premarket approval application in accordance with section 515 of the act. If the additional information is not submitted within 30 days following the date of the request, the Commissioner will consider the premarket notification to be withdrawn.

[42 FR 42526, Aug. 23, 1977, as amended at 57 FR 18066, Apr. 28, 1992; 59 FR 64295, Dec. 14, 1994; 63 FR 5253, Feb. 2, 1998; 83 FR 7385, Feb. 21, 2018; 89 FR 18793, Mar. 15, 2024]
Notes of Decisions
Cited in 52 cases (7 in the last 5 years), 1985–2026 · leading case: Buckman Co. v. Plaintiffs' Legal Comm., 531 U.S. 341 (2001).
Sort: Relevance Newest Treatment
Buckman Co. v. Plaintiffs' Legal Comm., 531 U.S. 341 (2001). · cites it 4× “Section 510(k) submissions must include the following: "Proposed labels, labeling, and advertisements sufficient to describe the device, its intended use, and the directions for its use," 21 CFR § 807.87 (e) (2000); "[a] statement indicating the device is similar to and/or…”
Walter Shuker v. Smith & Nephew PLC, 885 F.3d 760 (3rd Cir. 2018). “§ 360 (k) ; 21 C.F.R. § 807.87 . In many cases, § 510(k) approval rests not on proof of the device's safety, but merely on a finding that a device is "substantially equivalent" to a preexisting approved medical device.”
prod.liab.rep. (Cch) P 14,158 Dorothy Marie Reeves v. Acromed Corp., Acromed Corp., 44 F.3d 300 (5th Cir. 1995). · cites it 3× “21 C.F.R. § 807.87 . The Pre-Market Notification process requires applicants to submit descriptions of their devices and other information necessary for the agency to determine whether the devices are substantially equivalent.”
United States Ex Rel. Nowak v. Medtronic, Inc., 806 F. Supp. 2d 310 (D. Mass. 2011). · cites it 2× “§ 360 ; 21 C.F.R. § 807.87 (k). To obtain 510(k) clearance to market a device, the manufacturer must submit a premarket notification, including a certified “statement that the submitter believes, to the best of his or her knowledge, that all data and information submitted in the…”
United States v. Facteau, 89 F.4th 1 (1st Cir. 2023). · cites it 2× “" 21 C.F.R. §§ 807.87 (h), 807.92(a)(3)-(5).”
In Re Orthopedic Bone Screw Prods. Liab. Litig., Plaintiffs Legal Comm., Appellant, 159 F.3d 817 (3rd Cir. 1998). · cites it 2× “See 21 C.F.R. § 807.87 . For a device to be approved under the § 510(k) process, the FDA must determine that the new device has the same intended use as the predicate device and that it possesses the same technological characteristics or is as safe and effective as the predicate…”
Sekisui Am. Corp. v. Hart, 15 F. Supp. 3d 359 (S.D.N.Y. 2014). · cites it 3× “See 21 C.F.R. § 807.87 . See Tr. at 425:10-23, 426:4-16 (Timothy Ulatowski).”
Kubicki ex rel. Kubicki v. Medtronic, Inc., 293 F. Supp. 3d 129 (D.C. Cir. 2018). “at 83 (citing 21 C.F.R. § 807.87 ). It is important to recognize that "[t]he § 510(k) notification process is by no means comparable to the PMA process; in contrast to the 1,200 hours necessary to complete a PMA review, the § 510(k) review is completed in an average of only 20…”
prod.liab.rep. (Cch) P 14,318 Sam Feldt v. Mentor Corp., 61 F.3d 431 (5th Cir. 1995). · cites it 2× “As with the application for PMA, applicants must also submit their proposed labeling, 21 C.F.R. § 807.87 , for the FDA to determine compliance with general labeling regulations.”
Elizabeth & Clifford Kemp v. Medtronic, Inc., 231 F.3d 216 (6th Cir. 2000). “§ 1001 makes it a crime to make a fraudulent statement to a federal agency, and that 21 C.F.R. § 807.87 (J) requires every pre-market notification to contain a statement that the information contained therein is believed by the manufacturer to be truthful.”
Ivy Sports Med., LLC v. Sylvia Mathews Burwell, 767 F.3d 81 (D.C. Cir. 2014). “; 21 C.F.R. § 807.87 . If FDA agrees that the new device is substantially equivalent to an existing Class I or Class II device, it issues a classification order allowing the device to be marketed subject to appropriate restrictions.”
Lewis v. Johnson & Johnson, 991 F. Supp. 2d 748 (S.D.W. Va 2014). “They also argue that a third affirmative defense does not apply because it relates only to mandatory safety regulations, and no such regulations exist in this case. B. The FDA 510(k) Approval Process The TVT is a Class II medical device regulated by the FDA.”
Show all 52 citing cases →
— 21 C.F.R. § 807.87(e) — 1 case
Richardson v. Miller, 44 S.W.3d 1 (Tenn. Ct. App. 2000).
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.