---
kind: "section"
citation: "21 C.F.R. § 870.3600"
title: "21"
number: "870.3600"
heading: "External pacemaker pulse generator."
url: "https://uscodex.org/cfr/21/870.3600"
---

# §870.3600. External pacemaker pulse generator.

- (a) **Identification.** An external pacemaker pulse generator (EPPG) is a prescription device that has a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. This device, which is used outside the body, is used as a temporary substitute for the heart's intrinsic pacing system until a permanent pacemaker can be implanted, or to control irregular heartbeats in patients following cardiac surgery or a myocardial infarction. The device may have adjustments for impulse strength, duration, R-wave sensitivity, and other pacing variables.
- (b) **Classification.** Class II (special controls). The special controls for this device are:
  - (1) Appropriate analysis/testing must validate electromagnetic compatibility (EMC) within a hospital environment.
  - (2) Electrical bench testing must demonstrate device safety during intended use. This must include testing with the specific power source (i.e., battery power, AC mains connections, or both).
  - (3) Non-clinical performance testing data must demonstrate the performance characteristics of the device. Testing must include the following:
    - (i) Testing must demonstrate the accuracy of monitoring functions, alarms, measurement features, therapeutic features, and all adjustable or programmable parameters as identified in labeling;
    - (ii) Mechanical bench testing of material strength must demonstrate that the device and connection cables will withstand forces or conditions encountered during use;
    - (iii) Simulated use analysis/testing must demonstrate adequate user interface for adjustable parameters, performance of alarms, display screens, interface with external devices (e.g. data storage, printing), and indicator(s) functionality under intended use conditions; and
    - (iv) Methods and instructions for cleaning the pulse generator and connection cables must be validated.
  - (4) Appropriate software verification, validation, and hazard analysis must be performed.
  - (5) Labeling must include the following:
    - (i) The labeling must clearly state that these devices are intended for use in a hospital environment and under the supervision of a clinician trained in their use;
    - (ii) **Connector terminals should be clearly, unambiguously marked on the outside of the EPPG device.** The markings should identify positive (+) and negative (−) polarities. Dual chamber devices should clearly identify atrial and ventricular terminals;
    - (iii) The labeling must list all pacing modes available in the device;
    - (iv) Labeling must include a detailed description of any special capabilities (e.g., overdrive pacing or automatic mode switching); and
    - (v) Appropriate electromagnetic compatibility information must be included.

## Notes

### Amendments

[81 FR 22529, Apr. 18, 2016]

### Authority

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

### Source

Source: 45 FR 7907, Feb. 5, 1980, unless otherwise noted.

### Amendments

[81 FR 22529, Apr. 18, 2016]