On 28th July 2014, the FDA announced in a new final guidance a change in its approach to multiple predicate devices in 510(k) submissions and will no longer clear these devices because of the potential to cause long term damage to patients. This has been evident in the case of metal on metal hip implants which have been the subject of product recalls because of the generation of metal shavings that have damaged the tissue of some patients.
The new document states that “for a new device to be considered substantially equivalent to a predicate device, the new device must have the same intended use as the predicate device and the same technological characteristics or different technological characteristics that do not raise different questions of safety and effectiveness than the predicate device."
The use of more than one "substantially equivalent" predecessor device was known as a "split predicate" and involved cases in which a company used one device to show equivalence regarding intended use and another device to prove substantially equivalent technology.
The document also states that multiple predicate devices are acceptable for cases not involving a split predicate, such as "when combining features from two or more predicate devices with the same intended use into a single new device, when seeking to market a device with more than one intended use, or when seeking more than one indication for use under the same intended use." Even those devices should designate a primary predicate device to assist the application reviewers.
The remainder of the guidance contains minor changes and gives an overview of the 510k pathway. The Regulatory Affairs Professional Society points out that planned changes to the regulation of modifications of already cleared devices and reforms to the "abbreviated" 510(k) pathway were left out of the document.
The guidance in full can be found here.