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. § 807.100

FDA action on a premarket notification

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

(a) After review of a premarket notification, FDA will:

(1) Issue an order declaring the device to be substantially equivalent to a legally marketed predicate device;

(2) Issue an order declaring the device to be not substantially equivalent to any legally marketed predicate device;

(3) Request additional information; or

(4) Withhold the decision until a certification or disclosure statement is submitted to FDA under part 54 of this chapter.

(5) Advise the applicant that the premarket notification is not required. Until the applicant receives an order declaring a device substantially equivalent, the applicant may not proceed to market the device.

(b) FDA will determine that a device is substantially equivalent to a predicate device using the following criteria:

(1) The device has the same intended use as the predicate device; and

(2) The device:

(i) Has the same technological characteristics as the predicate device; or

(ii)(A) Has different technological characteristics, such as a significant change in the materials, design, energy source, or other features of the device from those of the predicate device;

(B) The data submitted establishes that the device is substantially equivalent to the predicate device and contains information, including clinical data if deemed necessary by the Commissioner, that demonstrates that the device is as safe and as effective as a legally marketed device; and

(C) Does not raise different questions of safety and effectiveness than the predicate device.

(3) The predicate device has not been removed from the market at the initiative of the Commissioner of Food and Drugs or has not been determined to be misbranded or adulterated by a judicial order.

[57 FR 58403, Dec. 10, 1992, as amended at 63 FR 5253, Feb. 2, 1998]
Notes of Decisions
Cited in 23 cases (3 in the last 5 years), 1994–2026 · leading case: PhotoMedex, Inc. v. Irwin, 601 F.3d 919 (9th Cir. 2010).
Sort: Relevance Newest Treatment
PhotoMedex, Inc. v. Irwin, 601 F.3d 919 (9th Cir. 2010). “§ 360 (k); 21 C.F.R. § 807.100 . In other words, that device receives “510(k) clearance” and can be put on the market.”
Ivy Sports Med., LLC v. Sylvia Mathews Burwell, 767 F.3d 81 (D.C. Cir. 2014). “See 21 C.F.R. § 807.100 . But if FDA disagrees with the proposed classification, the device 5 remains in Class III and must go through the pre-market approval process, unless FDA subsequently approves a petition for de novo classification.”
Rodriguez v. Stryker Corp., 680 F.3d 568 (6th Cir. 2012). “§ 360(k); 21 C.F.R. § 807.100 . Stryker received permission through the 510(k) process to market its pump with a single indication for use: “to provide continuous infusion of a local anesthetic directly into the intra-operative site for postoperative pain management.”
In Re Cryomedical Sciences, Inc. Sec. Litig., 884 F. Supp. 1001 (D. Maryland 1995). · cites it 2× “4 21 C.F.R. §§ 807.100 (a), 814.1(e); 21 U.”
United States v. Facteau, 89 F.4th 1 (1st Cir. 2023). “§ 360c(i)(1)(A); 21 C.F.R. § 807.100 (b). At least ninety days before introducing a new device to the market, a manufacturer seeking § 510(k) clearance must submit a premarket notification to the FDA.”
CardioVention, Inc. v. Medtronic, Inc., 483 F. Supp. 2d 830 (D. Minnesota 2007). “21 C.F.R. § 807.100 (b). CardioVention asserts that Medtronic’s 510(k) submission to the FDA is relevant because it lists CardioVention’s CORx as a “predicate device” and characterizes it as “substantially equivalent” to the Resting Heart.”
United States of Am.,plaintiff-Counter-Defendant-Appellee v. Snoring Relief Labs Inc.,defendant-Counter-Claimant-Appellant, 210 F.3d 1081 (9th Cir. 2000). “See 21 C.F.R. § 807.100 . Snoring Relief tried to become the first company to market a self-fitting, anti-snoring mouthpiece without a prescription.”
Ginochio v. Surgikos, Inc., 864 F. Supp. 948 (N.D. Cal. 1994). “see also 21 C.F.R. § 807.100 (b). 5 . Defendants cite some regulations which are not general controls but which are discretionary, but do not argue that the FDA has applied them to the Mieroloc device.”
Ivy Sports Med., LLC v. Burwell, 174 F. Supp. 3d 130 (D.D.C. 2016). “If the FDA determines that the device is substantially equivalent to an existing device, the agency issues a classification order “declaring the device to be substantially equivalent'to a legally marketed predicate device,” 21 C.F.R. § 807.100 (a)(1), which “allow[s] the *134…”
Baker v. Danek Med., 35 F. Supp. 2d 865 (N.D. Fla. 1998). · cites it 2× “§§ 360c(c)(2)(C),(f)(1); 21 C.F.R. § 807.100 (b). Because substantial equivalence is governed by Section 510(k) of the FDCA, 21 U.”
Ivy Sports Med., LLC v. Sebelius, 938 F. Supp. 2d 47 (D.D.C. 2013). “See also 21 C.F.R. § 807.100 (b). If the agency determines a new device is substantially equivalent to a predicate device, the new device is cleared and subject to the same regulatory Class controls as the predicate.”
James v. Diva Int'l, Inc., 803 F. Supp. 2d 945 (S.D. Ind. 2011). “21 C.F.R. § 807.100 . Additionally, the FDA regulations govern the form and substance of the information required for a submission under Section 510(k), including proposed labeling.”
Show all 23 citing cases →
— 21 C.F.R. § 807.100(a) — 1 case
Griffin v. Medtronic Inc (4th Cir. 1996).
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.