GroundRules
21 CFR 884.2675: Fetal scalp circular (spiral) electrode and applicator.
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 884—OBSTETRICAL AND GYNECOLOGICAL DEVICES
- Subpart C—Obstetrical and Gynecological Monitoring Devices
(a) Identification. A fetal scalp circular (spiral) electrode and applicator is a device used to obtain a fetal electrocardiogram during labor and delivery. It establishes electrical contact between fetal skin and an external monitoring device by a shallow subcutaneous puncture of fetal scalp tissue with a curved needle or needles. This generic type of device includes nonreusable spiral electrodes and reusable circular electrodes.
(b) Classification. Class II (performance standards).
Collected 2026-08-27T02:24:47Z. Source file · JSON