As medical devices become more connected, they need to be able to safely, securely, and effectively exchange and use information among one or more devices, products, technologies, or systems. The FDA has added new content to our digital health webpages describing our efforts to promote safe interoperability of medical devices.
The FDA supports the smart, secure, and safe interaction among different medical devices and information systems. The agency has been collaborating with hospitals, health care providers, manufacturers, standards development organizations, and other interested parties to promote medical device interoperability.
FDA activities to promote the interoperability of medical devices include:
- Release of draft guidance, Design Considerations and Pre-market Submission Recommendations for Interoperable Medical Devices
- Collaboration with standards development organizations
- Engagement with other federal agencies, such as the Office of the National Coordinator for Health IT (ONC)
The FDA continues working toward development and availability of effective interactions between medical devices to improve patient safety, reduce errors and adverse events, encourage innovation, and facilitate new models of health care delivery.
Thank you,
Food and Drug Administration
Center for Devices and Radiological Health
Food and Drug Administration
Center for Devices and Radiological Health
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