Commentary by Covington & Burling LLP on the regulatory and predicate requirement implications of FDA Draft Guidance for Industry and Food and Drug Administration Staff - The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)]. February 7, 2012.
This commentary included analysis specific to FDA guidance comments on the use of predicate devices:
The draft guidance states that FDA generally must be able to address Decision Points 1 through 4, above, using one “primary” predicate device.19 In the draft guidance FDA states that it believes the use of a split predicate is inconsistent with the 510(k) regulatory standard.20 However, according to the draft, FDA will accept the use of “multiple” predicates and “reference” devices to show substantial equivalence in some cases.21
According to the draft guidance, if a manufacturer intends to use multiple predicate devices to help demonstrate substantial equivalence, each predicate device must have the same intended use as the new device, and any differences in technological characteristics must not raise different questions of safety and effectiveness. For example, a manufacturer could cite two different predicates, each with an indication falling within the same general intended use (e.g., fixation of bone fractures in the shaft of a bone and on the ends of a bone), to support clearance for both indications. As another example, a manufacturer may use multiple predicate devices when the new device represents a combination of the technologies and uses of the predicate devices and the technologies are well-understood. However, where the device combination results in a new intended use or raises different questions of safety and effectiveness (e.g., the combination introduces an added risk to patients or creates new or unstudied device capabilities), the new device would be found NSE.22
In addition, in some circumstances, a manufacturer may cite one or more “reference devices.” A reference device is not considered by FDA to be a predicate device, but may be used to address certain performance characteristics of the new device.23 A reference device may only be used if a manufacturer has successfully navigated through Decision Point 4 using a primary predicate (i.e., CDRH must have determined that the proposed device has different technological characteristics than the primary predicate device, but those characteristics do not raise different questions of safety or effectiveness). In such cases, a reference device – which may have different intended uses or different technological characteristics that raise different questions or safety and effectiveness – may be cited to address performance characteristics of the new device.24 For example, a manufacturer can cite the reference device to support the scientific appropriateness of methods used to assess the safety and efficacy of the new device.25
