---
kind: "section"
citation: "21 C.F.R. § 882.1630"
title: "21"
number: "882.1630"
heading: "Cranial motion measurement device."
url: "https://uscodex.org/cfr/21/882.1630"
---

# §882.1630. Cranial motion measurement device.

- (a) **Identification.** A cranial motion measurement device is a prescription device that utilizes accelerometers to measure the motion or acceleration of the skull. These measurements are not to be used for diagnostic purposes.
- (b) **Classification.** Class II (special controls). The special controls for this device are:
  - (1) The technical parameters of the device, hardware and software, must be fully characterized and include the following information:
    - (i) Hardware specifications must be provided. Additionally, verification and validation testing as well as a hazard analysis must be performed.
    - (ii) Software must be described in detail in the Software Requirements Specification (SRS) and Software Design Specification (SDS). Additionally, software verification and validation testing as well as a hazard analysis must be performed.
  - (2) The device parts that contact the patient must be demonstrated to be biocompatible.
  - (3) The device must be designed and tested for electrical, thermal, and mechanical safety, and electromagnetic compatibility (EMC).
  - (4) Clinical performance testing must demonstrate the accuracy, precision, stability, and repeatability of measuring cranial motion per the intended use in the intended use environment.
  - (5) The labeling must include:
    - (i) **The intended use population and the intended use environment.**
    - (ii) Instructions for technicians to convey to patients regarding the collection of cranial acceleration data to ensure device measurement accuracy, precision, stability, and repeatability.
    - (iii) Information allowing clinicians to understand potential sources of variability in the measurement to help recognize and identify changes in the measurement.

## Notes

### Amendments

[82 FR 35071, July 28, 2017]

### Authority

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

### Source

Source: 44 FR 51730, Sept. 4, 1979, unless otherwise noted.

### Amendments

[82 FR 35071, July 28, 2017]