“Content of Premarket Submissions for Device Software Functions” covers recommended documentation sponsors should include in premarket submissions for FDA’s evaluation of safety and effectiveness of device software functions. The agency is hosting a webinar for industry on July 20 to provide an overview and answer questions about the new final guidance.
The final guidance includes recommendations for various elements of animal studies, including the credentials for personnel conducting an animal study, and the study planning and conduct process, including selecting an appropriate animal model, study monitoring, and study evaluation.
Manufacturers preparing premarket submissions should provide performance specifications for the quantitative imaging functions, supporting performance data, and sufficient information for the end user to obtain, understand and interpret the values provided.
With the ever-increasing adoption of connected devices, the agency is emphasizing the need for effective cybersecurity.
The center is working to address the delays in meeting review timelines for product submissions.
The draft provides suggestions on device design, labeling and documentation that should be included in premarket submissions.
The agency issued a draft guidance that gives manufacturers information about design considerations and pre-market submissions.