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U.S. Department of Health and Human Services

Medical Devices

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Description of 510(k) "Substantial Equivalence" Decision-Making Process (Accessible Text)

This flowchart depicts the 510(k) "substantial equivalence" decision-making process. 510(k) submissions compare new devices to marketed devices. FDA requires additional information if the relationship between marketed and "predicate" (pre-amendments or reclassified post-amendments) devices is unclear. The decision tree asks questions and the yes or no response determines the path through the flowchart. Step 1. Does the new device have the same indication statement? If the response is yes, go to Step 3. If no, follow Step 2. Step 2: Do the differences alter the intended therapeutic/diagnostic/etc effect (in deciding, you may consider impact on safety and effectiveness)? (This decision is normally based on descriptive information alone, but limited testing information is sometimes required.) If the response is yes, the new device has a new intended use and the device is determined not substantially equivalent. If the response is no, proceed to Step 3. The new device has the same intended use and may be "substantially equivalent." Step 3: Does the new device have the same technological characteristics, e.g. design, materials, etc.? If the response is yes, proceed to Step 5.

If the response is no, proceed to Step 4. Step 4: Could the new characteristics affect safety or effectiveness? If the response is no, proceed to Step 5. If yes, proceeded to Step 6. Step 6: Do the new characteristics raise new types of safety or effectiveness questions. If the response is yes, the device is determined not substantially equivalent. If the response is no, proceed to Step 7. Step 7: Do accepted scientific methods exist for assessing effects of the new characteristics? If the response is no, the device is determined not substantially equivalent. If yes, proceed to Step 8. Step 8: Are performance data available to assess effects of new characteristics? (Data may be in the 510(k), other 510(k)s, the Center's classification files, or the literature.) Proceed to Step 9. Step 9: Does the performance data demonstrate equivalence? If the response is no, the device is determined not substantially equivalent. If yes, the device is determined "substantially equivalent."

Back to Step 5: Are the descriptive characteristics precise enough to ensure equivalence? If the response is yes, the device is determined "substantially equivalent." If no, proceed to Step 8. Step 8: Are the performance data available to assess equivalence? If the response is no, performance data is required. Proceed to Step 9. Step 9: Does the performance data demonstrate equivalence? If the response is no, the device is determined not substantially equivalent. If the response is yes, the device is determined "substantially equivalent."