In this discussion, any biological effect of ultrasound that is accompanied by temperature increments less than 1 degrees C above normal physiologic levels is called a mechanical effect. However, one should keep in mind that the term mechanical effect also includes processes that are not of a mechanical nature but arise secondary to mechanical interaction between ultrasound and tissues, such as chemical reactions initiated by free oxygen species generated during cavitation and sonoluminescence. Investigations with laboratory animals have documented that pulsed ultrasound can produce damage to biological tissues in vivo through nonthermal mechanisms. The acoustic output used to induce these adverse bio-effects is considerably greater than the output of diagnostic devices when gas bodies are not present. However, low-intensity pulsed ultrasound is used clinically to accelerate the bone fracture repair process and induce healing of nonunions in humans. Low-intensity pulsed ultrasound also has been shown to enhance repair of soft tissue damage and accelerate nerve regeneration in animal models. Although such exposures to low intensity do not appear to cause damage to exposed tissues, they do raise questions about the acoustic threshold that might induce potentially adverse developmental effects in the fetus. To date, bioeffects studies in humans do not substantiate a causal relationship between diagnostic ultrasound exposure during pregnancy and adverse biological effects to the fetus. However, the epidemiologic studies were conducted with commercially available devices predating 1992, having outputs not exceeding a derated spatial-peak temporal-average intensity (ISPTA.3) of 94 mW/cm2. Current limits in the United States allow an ISPTA.3 of 720 mW/cm2 for obstetric modes. At the time of this report, available evidence, experimental or epidemiologic, is insufficient to conclude that there is a causal relationship between obstetric diagnostic ultrasound exposure and adverse nonthermal effects to the fetus. However, low-intensity pulsed ultrasound effects reported in humans and animal models indicate a need for further investigation of potentially adverse developmental effects.