---
kind: "section"
citation: "21 C.F.R. § 890.3480"
title: "21"
number: "890.3480"
heading: "Powered lower extremity exoskeleton."
url: "https://uscodex.org/cfr/21/890.3480"
---

# §890.3480. Powered lower extremity exoskeleton.

- (a) **Identification.** A powered lower extremity exoskeleton is a prescription device that is composed of an external, powered, motorized orthosis that is placed over a person's paralyzed or weakened limbs for medical purposes.
- (b) **Classification.** Class II (special controls). The special controls for this device are:
  - (1) Elements of the device materials that may contact the patient must be demonstrated to be biocompatible.
  - (2) Appropriate analysis/testing must validate electromagnetic compatibility/interference (EMC/EMI), electrical safety, thermal safety, mechanical safety, battery performance and safety, and wireless performance, if applicable.
  - (3) Appropriate software verification, validation, and hazard analysis must be performed.
  - (4) Design characteristics must ensure geometry and materials composition are consistent with intended use.
  - (5) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. Performance testing must include:
    - (i) Mechanical bench testing (including durability testing) to demonstrate that the device will withstand forces, conditions, and environments encountered during use;
    - (ii) Simulated use testing (i.e., cyclic loading testing) to demonstrate performance of device commands and safeguard under worst case conditions and after durability testing;
    - (iii) Verification and validation of manual override controls are necessary, if present;
    - (iv) The accuracy of device features and safeguards; and
    - (v) Device functionality in terms of flame retardant materials, liquid/particle ingress prevention, sensor and actuator performance, and motor performance.
  - (6) Clinical testing must demonstrate a reasonable assurance of safe and effective use and capture any adverse events observed during clinical use when used under the proposed conditions of use, which must include considerations for:
    - (i) Level of supervision necessary, and
    - (ii) Environment of use (e.g., indoors and/or outdoors) including obstacles and terrain representative of the intended use environment.
  - (7) A training program must be included with sufficient educational elements so that upon completion of training program, the clinician, user, and companion can:
    - (i) Identify the safe environments for device use,
    - (ii) Use all safety features of device, and
    - (iii) Operate the device in simulated or actual use environments representative of indicated environments and use.
  - (8) Labeling for the Physician and User must include the following:
    - (i) Appropriate instructions, warning, cautions, limitations, and information related to the necessary safeguards of the device, including warning against activities and environments that may put the user at greater risk.
    - (ii) **Specific instructions and the clinical training needed for the safe use of the device, which includes—**
      - (A) Instructions on assembling the device in all available configurations;
      - (B) Instructions on fitting the patient;
      - (C) Instructions and explanations of all available programs and how to program the device;
      - (D) Instructions and explanation of all controls, input, and outputs;
      - (E) Instructions on all available modes or states of the device;
      - (F) Instructions on all safety features of the device; and
      - (G) **Instructions for properly maintaining the device.**
    - (iii) Information on the patient population for which the device has been demonstrated to have a reasonable assurance of safety and effectiveness.
    - (iv) Pertinent non-clinical testing information (e.g., EMC, battery longevity).
    - (v) **A detailed summary of the clinical testing including—**
      - (A) Adverse events encountered under use conditions,
      - (B) Summary of study outcomes and endpoints, and
      - (C) Information pertinent to use of the device including the conditions under which the device was studied (e.g., level of supervision or assistance, and environment of use (e.g., indoors and/or outdoors) including obstacles and terrain).

## Notes

### Amendments

[80 FR 25529, May 4, 2015]

### Authority

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

### Source

Source: 48 FR 53047, Nov. 23, 1983, unless otherwise noted.

### Amendments

[80 FR 25529, May 4, 2015]