The focused, large amplitude pressure fields produced by ESW lithotripsy devices were shown in the early 1980s to provide an efficient means for fragmenting urinary tract calculi. More recently, orthopedic applications of intense pressure pulses for pain relief and fracture healing have been developed. Under the US Medical Device Amendments of 1976, ESW therapy devices were deemed Class III, meaning that a pre-market application typically would be supported by both pre-clinical and clinical studies. This classification still applies, except for ESW lithotripters indicated for fragmenting kidney and ureteral calculi. These devices were reclassified to Class II in 2000, resulting in a simpler path to market in which a demonstration of substantial equivalence to a currently marketed device is sufficient. As part of its regulatory responsibility to address the safety and effectiveness of these devices, particularly with regard to acoustic output, the US Food and Drug Administration has recognized two International Electrotechnical Commission (IEC) standards for ESW lithotripters, one covering field measurements (IEC 61846) and the other dealing with labeling and other safety aspects (IEC 60601-2-36). Although these standards were designed primarily for lithotripsy, the FDA has used them where applicable in the regulatory analysis of other ESW therapy devices.