Are you ready for the FDA guidance on the design of Interoperable Medical Devices?
By Deb Bartel,
This post was recently updated on September 19, 2018
If your electronic medical device exchanges data with other devices, you need to read the new draft guidance just published by the FDA. This document contains recommendations intended to promote the safe and effective exchange of information between devices. Make sure you and your team are aware of these best practices, so you can incorporate them into your medical device.
What’s in this draft guidance document?
Within this guidance, “interoperability” is defined as the ability of two or more products, technologies or systems to exchange information and to use the information that has been exchanged.
Design Considerations
These specific development and design considerations should be taken into account:
- Technology to support the purpose for the data interface (e.g., send-only, receive-only, control)
- The expertise and limitations of expected users
- Risk identification, assessment, and mitigation
- Validation and verification to ensure that the devise is working correctly before delivery and continues to work in real use
- Labeling to ensure safe, predictable use
Download the FDA draft guidance here: Design Considerations and Pre-market Submission Recommendations for Interoperable Medical Devices
Do you need more help implementing these recommendations within your organization? Talk to our CSV experts to see how they can help.
About the Author:
Deb Bartel is a long-time leader of software quality and information system initiatives. Her expertise is built on 25 years of work in pharmaceuticals, medical device, chemicals, and textile manufacturing industries. She is a Principal at Praxis Life Sciences, where she is responsible for the Computer System Validation (CSV) and Software Quality Assurance (SQA) practice.
Deb has trained hundreds of Life Sciences professionals in risk-based computer system validation.
Copyright Policy
Unless otherwise noted, Praxis Life Sciences, LLC is the legal copyright holder of all (written, multimedia and graphic) material on this website and it may not be used, reprinted, (partially) modified or published without written consent. A link to Validation Center must appear in all copies of any artwork or content, including articles and press releases.
You are welcome to share this article on social media so long as you link back directly to this post (providing the link). No copy & paste of this content will be allowed under any circumstances.
