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U.S. Department of Health and Human Services

Medical Devices

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Appendix A: Proposed 510(k) Decision-Making Flowchart Process

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The following decisions should be answered in sequential order to determine if the new device will receive a "Not Substantially Equivalent" (NSE) or "Substantially Equivalent" (SE) determination. The below decision making process is not intended to be used as a "stand-alone" document and should only be considered in conjunction with the accompanying text in the guidance document.

Originating step: identification of the new device and the predicate device.

Decision 1: Is the new device compared to a legally marketed predicate device? The new device will receive a NSE determination if the identified predicate device is not legally marketed per 21 CFR 807.100(b)(3) and the 510(k) decision making process is complete. However, if the identified predicate is legally marketed a review of all labeling is completed to assure that it is consistent with IFU statements and features. A review of data sources is also completed, as applicable. The decision making process proceeds to Decision 2. Refer to section IV.C of the guidance document for a discussion on predicate devices.

Decision 2: Does the new device have the same intended use as the predicate device? Per 21 CFR 807.100(b)(1), the new device will receive a NSE determination if the new device has a different intended use as compared to the predicate and the 510(k) decision making process is complete. However, if the devices have the same intended use, a review of design, materials, energy source, and other features of the devices is completed. The decision making process proceeds to Decision 3. Refer to section IV.D of the guidance document for a discussion on intended use.

Decision 3: Does the new device have the same technological characteristics as the predicate device? The new device will receive a SE determination if it has the same technological characteristics as the predicate device, per 21 CFR 807.100(b)(2)(i), and the 510(k) decision making process is complete. However, if the devices have different technological characteristics the decision making process proceeds to Decision 4. Refer to section IV.E of the guidance document for a discussion on Technological Characteristics.

Decision 4: Do the differences in technological characteristics between the new device and the predicate raise different questions of safety and effectiveness? The new device will receive a NSE determination if the differences in the technological characteristics raise different questions of safety and effectiveness per 21 CFR 807.100(b)(2)(ii)(C) and the 510(k) decision making process is complete. However, if the differences do not raise different safety and effectiveness questions, the proposed scientific methods for evaluating the different characteristics’ effects on safety and effectiveness are reviewed. The decision making process proceeds to Decision 5a. Refer to and section IV.F of the guidance document for a discussion on requests for performance data.

Decision 5a: Are the methods for evaluating the different characteristics’ effects on safety and effectiveness acceptable? Per 21 CFR 807.100(b)(2)(ii)(B), the new device will receive a NSE determination if the proposed methods are not acceptable and the 510(k) decision making process is complete. However, if the methods are acceptable the data are reviewed and the decision making process proceeds to Decision 5b.

Decision 5b: Do the data demonstrate equivalence and support the indications? The new device will receive a NSE determination if the provided data do not demonstrate equivalence to the predicate and do not support the indications. If the data do demonstrate equivalence and support the indications, the new device will receive a SE determination. Regardless of the equivalence determination, the 510(k) decision making process is complete.