FDA Draft Guidance for Electro-Surgical Devices

The link provided is to an FDA Draft Guidance dated 3/24/14 entitled “Premarket Notification [510(k)] Submissions for Electrosurgical Devices for General Surgery”. The comment period ends 90 days later.It provides an example predicate comparison table and many information for key elements of a premarket submission. Section V is on Software and mostly just refers to the FDA’s general software submission guidance and Off-the-shelf software guidance. It does state that generally the Level of Concern for the software is Moderate. It also states that information should be provided on cybersecurity including Confidentiality Integrity, Availability, and Accountability.

Cybersecurity Review

Our cybersecurity experts are NESSUS Pro Licensed and can quickly remediate cybersecurity deficiencies with your medical device or digital health software.  Planning, requirements, validation, and submissions – we can assist with all.

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