On September 6, 2017, FDA-CDER & CBER issued a final guidance document entitled Design Considerations and Pre-market Submission Recommendations for Interoperable Medical Devices.
The guidance document defines an interoperable medical device as a device with the ability to exchange and use information through an electronic interface with another medical product or non-medical product.
During the design phase the guidance recommends applying these considerations to the interface:
- Purpose of the electronic interface
- The anticipated users
- Risk management
- Verification and validation
- Labeling considerations
- Use of consensus standards
Pre-market submission should include:
- A device description
- Risk analysis
- Verification and validation
- Labeling
The Federal Register announcement says that FDA recognizes that it would take up to 60 days to put the guidance document in place. Pre-market submissions for interoperable medical devices made after 60 days should include the information covered by the guidance.
FDA plans to hold a webinar on the guidance document on October 26, 2017.