CDRH Issues Draft Guidance on Substantial Equivalence Determinations

FDAUpdate — CDRH Issues Draft Guidance on Substantial Equivalence Determinations

The Center for Device and Radiological Health (CDRH) is the branch of the FDA responsible for managing premarket approval of all medical devices, as well as ensuring the manufacturing, performance and safety of devices. The CDRH was busy in 2011 producing numerous Draft Guidance documents on the regulation of medical devices. None may be as important as the one released at the end of December titled “The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)].” It cuts to the heart of the premarket approval process – substantial equivalence to a predicate device.

The Guidance includes a number of changes including proposing a new decision making flowchart. A primary purpose of the draft guidance is to clarify certain critical points in the substantial equivalence decision-making process, which lead to the flowchart. The Guidance also updates the approaches to the Special 510(k) and the Abbreviated 510(k) programs. If finalized, this draft guidance document could potentially have a significant impact on the 510(k) notification process.

Split Predicates Replaced by Reference Devices

A big change many in the industry will notice is the replacement of “split predicates.” A split predicate refers to a scenario, where a manufacturer is attempting to “split” the 510(k) decision-making process by demonstrating that a new device has the same “intended use” as one marketed device and the same “technological characteristics” as a second marketed device. This “split” has long been accepted by the CDRH. There is no explanation as to why the splits are now disallowed, merely a statement in a footnote that split predicates are inconsistent with the regulatory standards.

The split predicate is replaced by a new concept called “reference devices.” The Guidance explains that in some circumstances, “…a manufacturer may refer to legally marketed devices that have a different intended use or different technological characteristics that raise different questions of safety and effectiveness, to address specific scientific questions for a new device.” That is, “reference devices” may be used “to address certain performance characteristics of the new device.” (emphasis added).

The use of reference devices is not made completely clear in the Guidance and will likely create confusion if finalized. For example, the Guidance is clear that “reference device” is not a “predicate device.” This raises the question of how it is permitted since only predicate devices can be used in determining substantial equivalence. The confusion will rest with the CDRH’s “scientific and regulatory expertise to determine when” reference devices are appropriate to use.

Primary Predicate Device

The Guidance contines to allow multiple predicate devices but makes a new caveat. The Guidance states a recommendation that the “manufacturer identify the primary predicate device to which a substantial equivalence claim is being made.” Additionally, the submitter “should identify each device and explain why more than one predicate or a reference device” is necessary and appropriate to support substantial equivalence. Given the confusion raised by reference devices this justification may also be challenging to articulate.

There were other issues raised in the Guidance (such as clarifying intended use vs indications for use and addressing how technological changes effect safety and effectiveness). The pre-market approval process is a complicated and if finalized the Guidance will add new challenges. It’s important to consult with counsel before embarking on the pre-market approval path.

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CDRH Issues Draft Guidance on Substantial Equivalence Determinations

Split Predicates Replaced by Reference Devices

Primary Predicate Device

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