How to Keep 510(k) Submissions On Track: Client Alert
A Duval law firm client alert discusses the importance of 510(k) submitters persuading FDA that chosen indications for use fall under the umbrella of the chosen intended use statement. If they do not, the subject device will be found “not substantially equivalent.”
The alert cautions that “FDA frequently interprets the definition of ‘general versus specific intended use’ so narrowly that FDA often considers new indications for a 510(k) device to be a new intended use. When making a 510(k) submission, the FDA will often ‘play’ with the definitions to define a sponsor’s subject device in a manner that takes it off the 510(k) path. That is why it is critical for the sponsor to thoroughly understand the 510(k) substantial equivalence definition criterion, as well as FDA’s guidance documents so the sponsor can make arguments that ensure each definitional criterion is met. Otherwise the subject device is headed for the de novo or PMA path, and more time and expense.”
Duval notes that a new device can have a new indication for use that fits within the predicate device’s cleared intended use. “The key determinant,” it says, “is whether the new indications for use do not raise different questions of safety and effectives in comparison to the predicate device. The General/Specific Use Guidance is especially helpful in deciding when a proposed labeling change falls under the current general intended use statement for its device. In this guidance, FDA lists the two levels of analyses – ‘Levels of Specificity’ and ‘Decision-Making’ – for determining whether a claim being sought fits within the general intended use statement, or if such a claim changes the intended use.”
Additionally, the client alert offers tips for 510(k) submissions. For example, it says submitters should ensure the device claim is substantiated and remains a “tool” claim and not a “treatment” claim. “When, for example, a manufacturer decides to claim a device cleared for soft tissue ablation can be used in cardiac ablation that is simply a specific anatomic location in which the ‘tool’ may be used and still be within the general intended use. Cardiac tissue is soft tissue and if a physician were to be so inclined to ablate cardiac tissue with this device, nothing should prevent that from happening because FDA deems it an off-label use. When a claim is made that the same device can be used to treat atrial fibrillation, FDA is concerned that the claim for safe and efficacious use is unsubstantiated. FDA under its guidance calls these ‘therapeutic’ or ‘treatment’ claims. So an ablation device can be used to ablate cardiac tissue but cannot be claimed for use in treating atrial fibrillation.”