Introduction. The introduction of scientific achievements and modern technical capabilities are increasingly being introduced into practical health care, but regulatory documents do not always correspond to their requirements. The purpose of the study was the analysis of regulatory documents, regulating the activities of departments and offices of functional diagnostics. Material and methods. The descriptive method of statistics and the content analysis of the normative documents regulating the activities of the departments and cabinets of functional diagnostics for the period from 1924 to 2019 were used. Results. The analysis of the historical stages of the development of the functional diagnostics service in the Russian Federation and the regulatory support of the activities of specialized departments and offices showed that it is necessary to develop new regulatory documents, taking into account the modern capabilities of medical organizations in functional diagnostics. Conclusion. Current regulatory documents on security the work of the departments and cabinets of functional diagnostics has lost its relevance and requires the adoption of organizational decisions.