FDA Submissions for Interoperable Medical Devices

FDA Submissions for Interoperable Medical Devices – Comment Period Extended for Draft Guidance

Additional information on FDA’s recommendations for interoperable medical devices is available in our blog post entitled “A Closer Look at FDA’s Draft Guidance Regarding Premarket Submissions for Interoperable Medical Devices.”

On January 26, 2016, the FDA published a draft guidance entitledDesign Considerations and Pre-market Submission Recommendations for Interoperable Medical Devices.”  The document provides medical device manufacturers with assistance regarding product design and labeling of interoperable devices.

Interoperable medical devices are two or more devices that exchange data and information in a safe and effective manner. The ability to do this is a growing need within the healthcare industry, which is what drove the FDA to develop this draft guidance.

When the draft guidance was released in late January, the FDA asked interested persons to submit comments and suggestions by March 28, 2016. In response to a number of requests for an extension, on February 23rd, the FDA announced that the comment period will remain open for an additional 30 days. As such, interested persons should submit comments, questions, and/or concerns by April 28, 2016.

Do you manufacture a medical device or any other type of FDA-regulated product? We can help ensure that your product is compliant with all requirements. For additional information on how we can help you, contact us today.