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U.S. Department of Health and Human Services

Medical Devices

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510(k) “Substantial Equivalence” Decision Making Process

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Identify the new device and the predicate device, leads to Decision 1, is the predicate device legally marketed? (Refer to Section IV.C. Predicate Devices and 21 CFR 807.100(b)(3).  If no, Not Substantially Equivalent.  If yes, Review all labeling and assure that it is consistent with IFU statements.  Leads to Decision 2, do the devices have the same intended use?  (Refer to Section IV.D. Intended Use and 21 CFR 807.100(b)(1)).  If no, Not Substantially Equivalent.  If yes, review design, materials, energy source, and other features of the devices.  Leads to Decision 3, do the devices have the same technological characteristics?  (Refer to Section IV.E. Technological characteristics and 21 CFR 807.100(b)(2)(i) and (ii)(A)).  If yes, Substantially Equivalent.  If no, determine what questions of safety and effectiveness the different technological characteristics raise.  Leads to Decision 4, do the different technological characteristics of the devices raise different questions of safety and effectiveness?  (Refer to Sections IV.E. Technological Characteristics and IV.F Requests for Performance Data and 21 CFR 807.100(b)(2)(ii)(C)).  If yes, Not Substantially Equivalent. If no, review the proposed scientific methods for evaluating new/different characteristics' effects on safety and effectiveness.  Leads to Decision 5a, are the methods acceptable?  (Refer to Section IV.F Requests for Performance Data and 21 CFR 807.100(b)(2)(ii)(B)).  If no, Not Substantially Equivalent. If yes, evaluate performance data.  Leads to Decision 5b, do the data demonstrate substantial equivalence?  (refer to Section IV.F Requests for Performance Data and 21 CFR 807.100(B)(2)(ii)(B)).  If no, Not Substantially Equivalent. If yes, Substantially Equivalent.

This Flowchart 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 The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notification [510(k)].