As each company develops and modifies their devices, the question will ultimately come up at some point of whether a change or line expansion to an already marketed device needs a 510(k). The FDA no longer teaches the catch all route of “letter to file”, instead they take a very conservative approach when understanding the need for a 510(k). Some companies have attempted to attach the word “custom” to the size additions because these are not for the normal patients, but for the very small or very large patients. The FDA however sees the custom regulation differently.

So how does one decide whether a modification to a device needs a 510(k) or whether it truly falls under the custom device designation.

Any modification to a previously cleared device that could significantly impact the safety and effectiveness which is defined as the threshold under 21 CFR 807.81(a)(3), will require a new 510(k) submission. This statement could be interpreted a number of different ways. For instance, if you are adding a larger size to your device line, does this significantly impact the safety and effectiveness of the device? Probably not. But what if that size causes more wear due to its larger size, what if the attachment, range of motion, or mechanics are different than that in the cleared 510(k). An available FDA draft guidance document entitled “510(k) Device Modifications: Deciding When to Submit a 510(k) for a Change to an Existing Device” issued on July 27, 2011 helps medical device companies determine whether a 510(k) is necessary when a change is made to an existing device. Changes to labeling, technology, materials, etc. are a few of the modifications that are addressed in detail. Normally the “line in the sand” is if testing is needed to demonstrate that there are no new risks, then a 510(k) should be submitted regardless of those tests outcomes.

Manufacturing off-sizes or bigger or smaller sizes does not constitute a custom device. The FDA states on its website that a device can only be designated as a custom device in accordance with 21 CFR 812.3(b) and therefore be exempt from premarket approval or clearance if it complies with the following:

The custom device,

1. Necessarily deviates from devices generally available or from an applicable performance standard or premarket approval requirement in order to comply with the order of an individual physician or dentist;

2. Is not generally available to, or generally used by, other physicians or dentists;

3. Is not generally available in finished form for purchase or for dispensing upon prescription;

4. Is not offered for commercial distribution through labeling or advertising; and

5. Is intended for use by an individual patient named in the order of a physician or dentist, or is intended to meet the special needs of a physician or dentist, in the course of professional practice.#

When attempting to analyze the changes being made to your cleared device, it is important to understand which changes warrant a new 510(k). Very rarely will these changes constitute a custom device. If the change is benign enough that you believe a letter to file could suffice but testing is needed to substantiate that outcome, then FDA will want a 510(k). The risk of questions and burdensome request associated with sending in the 510(k) far outweighs the risk of a Warning Letter.

Erela can be reached at edana@mcra.com.