Final FDA 510(k) Substantial Equivalence Guidance

FDA issued a final guidance entitled “The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)]” dated July 28.2014. This guidance mentions software 18 times (including in the example). Software is considered one of the technological characteristics that could affect equivalence and examples include changes in the way software is used to analyze a patient’s anatomy or physiology.. The guidance also discusses the software information to be provided in the 510(k) related to demonstating substantial equivalence. The full guidance is at the link provided.

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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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