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Watch out! Exception to the Exemption

The US FDA has “re-classified” and “down-classified” and” exempted” HUNDREDS of medical devices through the last few years. It is difficult to keep track! EXEMPTION from filing is NOT the same as “reclassification.” Most Class 1 devices are “exempt” from a 510(k) submission, but many people do not realize that FDA has also “exempted” certain Class 2 devices—no 510(k) necessary prior to market!

But this can be quite a tricky proposition because FDA provides for each “panel” (medical specialty) a provision that EXCEPTS the EXEMPTION! FDA writes: A device may be exempt from 510(k) requirements if the FDA determines that a 510(k) is not required to provide reasonable assurance of safety and effectiveness for the device (see sections 510(l) and 510(m) of the Federal Food, Drug, and Cosmetic (FD&C) Act)i (.ft1) FDA refers to the “exceptions” as “ subject to certain limitations “ You need to fully understand those “certain limitations” and be prepared to defend your position to not file a 510(k) for devices that are supposed to be exempted.

But you should not get too giddy just yet! FDA states that “when the device meets any of the conditions described in §§ 862.9 through 892.9” there must still be a 510(k) submission. The MOST subjective part of the Exemption is the exception to the exemption is the requirement that the exemption only applies to a new device when it has “existing or reasonably foreseeable characteristics of commercially distributed devices within that generic type.”

So, what does that mean? It means you had better have a good comparison of your new device to other devices on the market! How do you do that? Frankly, you should find an objective regulatory consultant who can help you lay out the similarities and differences using reputable sources, including someone who knows how to mine the various FDA databases for current information. It can sometimes come down to how risk adverse your investors may be. You don’t want to develop a market for a product and then find out you should have filed a 510(k)!

Although FDA may typically file a warning letter to a company for which a 510(k) is required, unless the violations represent a danger to health or are egregious in nature. Civil Money penalties are more typically imposed. Unless there is outright fraud, FDA typically collaborates with the company to try to bring about compliance. But this can still be costly and time consuming and very disruptive to the trust of the customer. Other choices to avoid potential disagreements with FDA can nevertheless be cause for considerable time and cost, such as filing a 513g Determination.

Paladin Medical, Inc. will conduct a regulatory assessment and assist you in providing the documentation to your in-house regulatory files to support an exemption from 510(k) submission. And don’t forget, a Class 2 device is NOT exempt from Design Control and Review even if it is exempt from a 510(k) filing. Other requirements for exempt devices, such as “general controls” require compliance with certain quality regulations, and we can help with that too!