FDA Guidance: Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices
Date: 2014-12-10
Source: fda.gov
Abstract:
The Food and Drug Administration (FDA) recognizes that the progression to digital health offers the potential for better, more efficient patient care and improved health outcomes. To achieve this goal requires that many medical devices be interoperable with other types of medical devices and with various types of health information technology. The foundation for such inter-communication is hardware and software that transfer, store, convert formats, and display medical device data or medical imaging data.
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