---
kind: "section"
citation: "21 C.F.R. § 884.4350"
title: "21"
number: "884.4350"
heading: "Fetal head elevator."
url: "https://uscodex.org/cfr/21/884.4350"
---

# §884.4350. Fetal head elevator.

- (a) **Identification.** A fetal head elevator is a prescription device consisting of a mechanism that elevates the fetal head to facilitate delivery during a Caesarean section.
- (b) **Classification.** Class II (special controls). The special controls for this device are:
  - (1) The patient-contacting components of the device must be demonstrated to be biocompatible.
  - (2) Performance data must demonstrate the sterility of patient-contacting components of the device.
  - (3) Performance data must support the shelf life of the device by demonstrating continued sterility, package integrity, and device functionality over the identified shelf life.
  - (4) Non-clinical performance data must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be tested:
    - (i) Reliability testing of device deployment and retrieval under relevant use conditions must be conducted.
    - (ii) Testing of the maximum force applied to the fetal head in an anatomic model must be conducted.
    - (iii) Testing of uniform application of the elevator mechanism on the fetal head must be conducted.
  - (5) Labeling must include the following:
    - (i) Contraindication for use in the presence of active genital infection;
    - (ii) Specific instructions regarding the proper placement and use of the device; and
    - (iii) **A shelf life.**

## Notes

### Amendments

[82 FR 60114, Dec. 19, 2017]

### Authority

Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 l , 371.

### Source

Source: 45 FR 12684, Feb. 26, 1980, unless otherwise noted.

### Amendments

[82 FR 60114, Dec. 19, 2017]