This resource is the US FDA (Food and Drug Administration) core guidance on determining “substantial equivalence” in 510(k) premarket notifications.
About this document
The guidance explains in detail the FDA’s decision-making process for determining whether a new device is substantially equivalent to a predicate device, including whether the intended use is the same, whether differences in technological characteristics raise new questions of safety and effectiveness, and when performance data or clinical data are needed.
Applicable products and users
- Class II (and some Class I) medical devices planned for the US market via 510(k)
- Regulatory staff selecting predicate devices and writing substantial equivalence arguments
Main contents
- Decision flowchart for substantial equivalence
- Assessing differences in intended use and indications for use
- Differences in technological characteristics and performance data requirements
- Rules for using multiple predicate devices
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Related articles
- US FDA Medical Device 510(k) Submissions
- FDA Registration (Part 8): The eSTAR for FDA 510(k) Submissions Explained
- US FDA Medical Device Registration Services
Need help interpreting this document or assessing its impact on your product? EVERBIZ provides regulatory consulting and registration services – please contact us.
Note: this resource is for reference only. Please refer to the latest official version published by the issuing authority.