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The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)] Guidance for Industry and Food and Drug Administration Staff

\"FDA developed this document to provide guidance to industry and FDA staff about current review practices for premarket notification (510(k)) submissions. The intent of this guidance is to identify, explain, and clarify each of the critical decision points in the decision-making process FDA uses to determine substantial equivalence. This guidance is not intended to implement significant policy changes to the current 510(k) review process. Rather, the intent of this guidance is to enhance the predictability, consistency, and transparency of the 510(k) program by describing in greater detail the regulatory framework, policies, and practices underlying FDA's 510(k) review.\" - FDA

The 510(k) Program is closely tied to the classification of medical devices because it serves as the primary regulatory pathway for most Class II devices and some Class I devices that are not exempt from premarket notification requirements. The FDA classifies medical devices into three categories---Class I, II, and III---based on the level of risk they pose to patients and users. Class I devices are considered low risk and are often exempt from the 510(k) process. Class II devices, which present moderate risk, generally require a 510(k) submission. This submission must demonstrate that the new device is substantially equivalent to a legally marketed device, known as a predicate. Substantial equivalence means that the new device has the same intended use and similar technological characteristics as the predicate, or that any differences do not raise new questions of safety and effectiveness. Class III devices, which are high risk, typically require a more rigorous Premarket Approval (PMA) process instead of a 510(k). Therefore, the classification of a device directly determines whether the 510(k) pathway is applicable and what kind of evidence is needed to bring the device to market.

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