GroundRules
21 CFR 890.5700: Cold pack.
Where this section sits in the code
- Title 21—Food and Drugs
- CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES
- SUBCHAPTER H—MEDICAL DEVICES
- PART 890—PHYSICAL MEDICINE DEVICES
- Subpart F—Physical Medicine Therapeutic Devices
(a) Identification. A cold pack is a device intended for medical purposes that consists of a compact fabric envelope containing a specially hydrated pliable silicate gel capable of forming to the contour of the body and that provides cold therapy for body surfaces.
(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807. The device also is exempt from the current good manufacturing practice requirements of the quality management system regulation in part 820, except for requirements concerning records and complaint files under § 820.35 of this chapter.
Collected 2026-08-27T02:24:47Z. Source file · JSON