New FDA draft guidance for interoperable medical devices
FDA is issuing this draft guidance to assist industry and FDA staff in identifying specific considerations related to the ability of electronic medical devices to safely and effectively exchange and use exchanged information.
This draft guidance is not final nor is it in effect at this time, the FDA has extended the comment period for 30 days, until April 28, 2016.
The draft guidance, when finalized, will represent the current thinking of FDA on “Design Considerations and Pre-market Submission Recommendations for Interoperable Medical Devices”.