On January 26, 2016, the FDA published a draft guidance entitled “Design Considerations and Pre-market Submission Recommendations for Interoperable Medical Devices.”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 The ability to do this is a growing need within the healthcare industry, which is what drove the FDA to develop this draft guidance.
When the draft guidance was released in late January, the FDA asked interested persons to submit comments and suggestions by March 28, 2016.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.
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On Tuesday, February 19th, FDA published a draft guidance for medical device makers which identifies a process for companies to request nonbinding feedback on certain FDA Form 483 deficiencies noted...
April 18, 2016
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August 28, 2015
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