C.F.R. » Title 21 » CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES › SUBCHAPTER H—MEDICAL DEVICES › PART 880—GENERAL HOSPITAL AND PERSONAL USE DEVICES › Subpart F—General Hospital and Personal Use Therapeutic Devices

21 C.F.R. § 880.5725

Infusion pump

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(a) Identification. An infusion pump is a device used in a health care facility to pump fluids into a patient in a controlled manner. The device may use a piston pump, a roller pump, or a peristaltic pump and may be powered electrically or mechanically. The device may also operate using a constant force to propel the fluid through a narrow tube which determines the flow rate. The device may include means to detect a fault condition, such as air in, or blockage of, the infusion line and to activate an alarm.

(b) Classification. Class II (performance standards).

Notes of Decisions
Cited in 3 cases, 2002–2016 · leading case: Prather v. Abbot Labs., 960 F. Supp. 2d 700 (W.D. Ky. 2013).
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Prather v. Abbot Labs., 960 F. Supp. 2d 700 (W.D. Ky. 2013). “21 C.F.R. § 880.5725 (b). Prior to marketing a Class II medical device, the manufacturers must satisfy the FDA premarket approval process.”
Donna Ellis v. C. R. Bard, Inc., 311 F.3d 1272 (11th Cir. 2002). “See 21 C.F.R. § 880.5725 . However, no private right of action exists for a violation of the FDCA.”
United States ex rel. Witkin v. Medtronic, Inc., 189 F. Supp. 3d 259 (D. Mass. 2016). “21 C.F.R. § 880.5725 ; 42 C.F.R. § 405.201 (b); see Sec.”
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