On January 26, 2016, the FDA published a draft guidance entitled “Design Considerations and Pre-market Submission Recommendations for Interoperable Medical Devices.”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 The ability to do this is a growing need within the healthcare industry, which is what drove the FDA to develop this draft guidance.
When the draft guidance was released in late January, the FDA asked interested persons to submit comments and suggestions by March 28, 2016.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.
February 11, 2016
On February 9, 2016, the FDA published a draft guidance entitled “Display Devices for Diagnostic Radiology.” The document, which will replace a 2008 guidance (“Display Accessories for Full-Field...
February 16, 2016
Last week, we provided you with details on FDA’s recommendations for describing display devices in 510(k) premarket submissions. Did we leave you wanting more? Well if you were wishing for additional...
March 24, 2018
On Friday, March 16th, the FDA published a notice in the Federal Register, stating that the effective date for the amendments related to intended use would be delayed indefinitely. In the notice, the...