Issue Date: September 6, 2017
Issued by: Center for Devices and Radiological Health
Topic(s): 510(k), Anesthesiology , Neurological, Cardiovascular , General Hospital & Personal Use , Digital Health, Dental , Radiological Health
Status: Final
Design Considerations and Pre-market Submission Recommendations for Interoperable Medical Devices: Guidance for Industry and Food and Drug Administration Staff
As electronic medical devices are increasingly connected to each other and to other technology, the ability of these connected systems to safely and effectively exchange and use the information that has been exchanged becomes increasingly important. Advancing the ability of medical devices to exchange and use information safely and effectively with other medical devices as well as other technology offers the potential to increase efficiency in patient care. FDA intends to promote the development and availability of safe and effective interoperable medical devices. FDA is issuing this guidance to assist industry and FDA staff in identifying specific considerations related to the ability of electronic medical devices to safely and effectively exchange information and use exchanged information. This document highlights considerations that should be included in the development and design of interoperable medical devices and provides recommendations for the content of premarket submissions and labeling for such devices.
Download the Guidance Document
