FDA 'General Use' Classification for Surgical Instruments Intended for Specific Procedures

Question

I am working on a device that appears to fall under FDA product code GDI (Dissector) as defined in 21 CFR 878.4800, "Manual surgical instrument for general use." However, this device is intended for a specific procedure, and our labeling will reflect this specific use.
How does the FDA interpret the term "general" in this context? Is it an issue if the device is marketed for a specific procedure, even though many class I devices under 878.4800 are also marketed for specific uses?

Dr. Oliver Eidel · Accepted Answer

The term 'general' in this context refers to general surgical procedures rather than specialized surgery types (like pediatric or robotic). As long as your device is a nonpowered, hand-held instrument for use in general surgery, it can usually be classified under this regulation, even if your labeling targets a specific procedure. The FDA product code system is not always intuitive, but many class I devices are marketed for specific uses within the broader context of general surgery.
If there’s no identical class II device cleared by the FDA, you can classify your instrument as class I, 510(k) exempt. You’ll still need to list the device on the FURLS website and prepare rationale and labeling documentation.

FDA 'General Use' Classification for Surgical Instruments Intended for Specific Procedures

1 Answer

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