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USFDA Draft Guidance: Electronic Submission Template for Premarket Approval Applications (PMA) and Updates for Medical Device Submissions: Robotically-Assisted Surgical Devices
The FDA has issued two draft guidances in September 2026 covering important aspects of medical device regulatory submissions. One focuses on premarket submissions for robotically-assisted surgical devices (RASDs), while the other provides recommendations for the electronic submission of Premarket Approval (PMA) applications using the eSTAR template. These guidances highlight FDA's focus on structured technical evidence, software and cybersecurity considerations, clinical and
Sharan Murugan
2 hours ago3 min read