GroundRules
21 CFR 878.3910: Noninflatable extremity splint.
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 878—GENERAL AND PLASTIC SURGERY DEVICES
- Subpart D—Prosthetic Devices
(a) Identification. A noninflatable extremity splint is a device intended to immobilize a limb or an extremity. It is not inflatable.
(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9. If the device is not labeled or otherwise represented as sterile, it is exempt from the current good manufacturing practice requirements of the quality management system regulation in part 820 of this chapter, except for requirements concerning records and complaint files under § 820.35 of this chapter.
Collected 2026-08-27T02:24:47Z. Source file · JSON