"Safe" and "effective" are defined as follows: Safety: condition of presenting reasonably low risk of harm, injury, or loss when utilized in the specified indication; effectiveness: producing a desired, beneficial effect under the conditions of actual use. Categories for response to a DATTA question are defined as follows: established—technology demonstrated and accepted as safe and effective by the pracitcing medical community; investigational—largely confined to use under research protocol; unacceptable—risk/benefit ratio is unfavorable; indeterminate—no consensus to date, evidence insufficient for a definitive decision, may warrant further study.
Questions and Answers. JAMA. 1988;260(12):1779-1782. doi:10.1001/jama.1988.03410120125042