---
kind: "section"
citation: "21 C.F.R. § 878.4685"
title: "21"
number: "878.4685"
heading: "Extracorporeal shock wave device for treatment of chronic wounds."
url: "https://uscodex.org/cfr/21/878.4685"
---

# §878.4685. Extracorporeal shock wave device for treatment of chronic wounds.

- (a) **Identification.** An extracorporeal shock wave device for treatment of chronic wounds is a prescription device that focuses acoustic shock waves onto the dermal tissue. The shock waves are generated inside the device and transferred to the body using an acoustic interface.
- (b) **Classification.** Class II (special controls). The special controls for this device are:
  - (1) Non-clinical performance testing must be conducted to demonstrate that the system produces anticipated and reproducible acoustic pressure shock waves.
  - (2) The patient-contacting components of the device must be demonstrated to be biocompatible.
  - (3) Performance data must demonstrate that the reusable components of the device can be reprocessed for subsequent use.
  - (4) Performance data must be provided to demonstrate the electromagnetic compatibility and electrical safety of the device.
  - (5) Software verification, validation, and hazard analysis must be performed.
  - (6) Performance data must support the use life of the system by demonstrating continued system functionality over the labeled use life.
  - (7) Physician labeling must include:
    - (i) Information on how the device operates and the typical course of treatment;
    - (ii) A detailed summary of the device's technical parameters;
    - (iii) Validated methods and instructions for reprocessing of any reusable components; and
    - (iv) **Instructions for preventing hearing loss by use of hearing protection.**
  - (8) Patient labeling must include:
    - (i) Relevant contraindications, warnings, precautions, adverse effects, and complications;
    - (ii) Information on how the device operates and the typical course of treatment;
    - (iii) The probable risks and benefits associated with the use of the device;
    - (iv) Post-procedure care instructions; and
    - (v) **Alternative treatments.**

## Notes

### Amendments

[83 FR 9699, Mar. 7, 2018]

### Authority

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

### Source

Source: 53 FR 23872, June 24, 1988, unless otherwise noted.

### Amendments

[83 FR 9699, Mar. 7, 2018]