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FDA Clarifies Substantial Equivalence Requirements for 510(k) Submissions

FDA’s recently-released final guidance documentation for 510(k) submissions remains a hot topic for the orthopaedic industry. The final guidance attempts to clarify FDA’s substantial equivalence requirements. In reality, the document doesn’t provide a groundbreaking update. However, FDA does outline its recommendations on what needs to be submitted for your 510(k)—specifically, the process by which reviewers make substantially equivalent determinations.

In a 510(k) submission, you are trying to demonstrate that your device is substantially equivalent to another device already on the market. FDA then makes an assessment of the risks and benefits in a comparison between the devices. What are the key takeaways from the guidance document?


In a 510(k), also known as a Premarket Notification, you, as the submitter, identify one or more predicate devices in which you suggest to FDA that your device is at least as safe and effective as a device already on the market with the same intended use. It is not uncommon to identify multiple predicates, and one strategy to gain clearance utilizes a term coined as “split predicates.”

In the case of split predicates, you compare your device to one predicate that has the same intended use and to a different predicate that has similar technological characteristics. You are attempting to demonstrate substantial equivalence on an unfounded basis, akin to combining different attributes of more than one device into a single, nonexistent predicate.

FDA is clarifying that this strategy is inconsistent with the 510(k) regulatory standard. One high-profile event that illustrates the pitfalls of using split predicates is the recall of the DePuy ASR XL Acetabular Cup System metal-on-metal hip implant. As discussed in an article in The New England Journal of Medicine, “the device had three characteristics uniquely combined in the ASR XL, but were evaluated for substantial equivalence by comparing select characteristics to different predicate devices, none of which contained all of these characteristics, i.e. they were split predicates.”



Continue reading about FDA updates: 



CDRH: 2014-2015 Priorities

Recent orthopaedic 510(k) clearances

Coverage of submission and supplier expections from OMTEC

Additionally, the Agency is asking that submitters identify a primary predicate in their 510(k)s. The primary predicate is one with indications for use and characteristics most similar to your device. The guidance does, however, still allow for the use of multiple predicates. This would be relevant when you are combining features from two or more predicates with the same intended use into your device or when your device has more than one intended use. The submitter would still need to make appropriate comparisons between your device and each predicate. Alternatively, you can also identify reference devices that direct attention to similar situations seen in the past.


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