{"data":{"id":"us/21-cfr-870.3600","jurisdiction":"us","citation":"21 CFR 870.3600","heading":"External pacemaker pulse generator.","body":"(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.\n(b) Classification. Class II (special controls). The special controls for this device are:\n(1) Appropriate analysis/testing must validate electromagnetic compatibility (EMC) within a hospital environment.\n(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).\n(3) Non-clinical performance testing data must demonstrate the performance characteristics of the device. Testing must include the following:\n(i) Testing must demonstrate the accuracy of monitoring functions, alarms, measurement features, therapeutic features, and all adjustable or programmable parameters as identified in labeling;\n(ii) Mechanical bench testing of material strength must demonstrate that the device and connection cables will withstand forces or conditions encountered during use;\n(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\n(iv) Methods and instructions for cleaning the pulse generator and connection cables must be validated.\n(4) Appropriate software verification, validation, and hazard analysis must be performed.\n(5) Labeling must include the following:\n(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;\n(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;\n(iii) The labeling must list all pacing modes available in the device;\n(iv) Labeling must include a detailed description of any special capabilities (e.g., overdrive pacing or automatic mode switching); and\n(v) Appropriate electromagnetic compatibility information must be included.","path":["Title 21—Food and Drugs","CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES","SUBCHAPTER H—MEDICAL DEVICES","PART 870—CARDIOVASCULAR DEVICES","Subpart D—Cardiovascular Prosthetic Devices"],"source_url":"https://www.ecfr.gov/api/versioner/v1/full/2026-08-25/title-21.xml","current_through":"2026-08-25","vintage":"","retrieved_at":"2026-08-27T02:24:47Z","sha256":"3150ca98c7918a6310df83af5c0781bfcbc2e264c26ff65bb4e7e1c7d3173331","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-870.3545","next":"us/21-cfr-870.3605"},"notice":"GroundRules: Original legal text. Not legal advice."}