Regulatory Open Forum

As a regulatory professional, what do you need in order to feel comfortable with the determination that a device is a Class I device that is 510(k) exempt?

For me the answer is ... it depends.

Some are no-brainers but those are few and far between. When it's that easy, I rarely get asked to do a determination.

Some are a bit more complicated, and in those cases usually a careful reading of the regs and procode description AND applying the limitations of exemption make it clear. Looking at product recalls and warning letters for similar devices can also help, since it yields insight as to how FDA views devices in that area.

Some however are toss-ups where I don't feel comfortable giving a recommendation. For those, the 513(g) path is available. I often advice clients to apply for an FDA small business waiver immediately after they contact me just so that they can be prepared in case we need either a 513(g) or a 510(k).

As a regulatory professional, what do you need in order to feel comfortable with the determination that a device is a Class I device that is 510(k) exempt?

As a regulatory professional, what do you need in order to feel comfortable with the determination that a device is a Class I device that is 510(k) exempt?

As a regulatory professional, what do you need in order to feel comfortable with the determination that a device is a Class I device that is 510(k) exempt?

Hi Julie, 

You will have to identify the FDA product code and/or the 21 CFR regulation. The product code can lead you to the regulation. Once you identify the regulation review the classification section, which identifies the classification and exemption/premarket requirements. For example:

- Scissors used in cardiovascular surgery has a product code of OFA and can be found in 21 CFR 870.4500. This regulation says:

Section (b) exempts this device from premarket notification. Make sure you review the limitations to the exemption, such as different intended use than the regulations, device is used outside of generic type (eg. dental devices used in cardiovascular procedures), etc. If you are outside of the limitation and there isn't a regulation within that generic type, then you are required to meet premarket requirements.

As a regulatory professional, what do you need in order to feel comfortable with the determination that a device is a Class I device that is 510(k) exempt?

It is the identification that I'm asking about.  If your device's technology and intended use are identical to that in a product code or regulation, then that's easy, yes.  I was thinking more about potential application of the concept of substantial equivalence if one or the other is not identical.

Hi Julie, 

You will have to identify the FDA product code and/or the 21 CFR regulation. The product code can lead you to the regulation. Once you identify the regulation review the classification section, which identifies the classification and exemption/premarket requirements. For example:

- Scissors used in cardiovascular surgery has a product code of OFA and can be found in 21 CFR 870.4500. This regulation says:

Section (b) exempts this device from premarket notification. Make sure you review the limitations to the exemption, such as different intended use than the regulations, device is used outside of generic type (eg. dental devices used in cardiovascular procedures), etc. If you are outside of the limitation and there isn't a regulation within that generic type, then you are required to meet premarket requirements.

As a regulatory professional, what do you need in order to feel comfortable with the determination that a device is a Class I device that is 510(k) exempt?

Erica’s approach is, in my opinion, the correct way to handle the situation. The Product Code information on the FDA website identifies the relevant characteristic, including whether the device is 510(k) exempt. Remember that the class does not determine the need for a 510(k). (The infant heel warmer, Product Code MPO, is a Class 1 device that requires a 510(k) based on the intended use, not the class.)

The regulations provide additional information. In general, xxx.9 provides limitations that the manufacturer must take into account.

There are Warning Letters that identify cases in which the manufacturer exceeds the xxx.9 limitations. Often, the Warning Letters cite problems in intended use as inferred from marketing claims. To see an example, read the November 19, 2015 Warning Letter to A-1 Engineering. I’ve cited two relevant paragraphs, which are “stock” elements in this kind of Warning Letter.

Because there is evidence that the Neurotris SX-Series machines and PICO Toner are intended for uses that are different from those of legally marketed devices classified under 21 CFR §890.5660, they exceed the limitations described in 21 CFR §890.9(a) and are not exempt from premarket notification.

Our office requests that A-1 Engineering immediately cease activities that result in the misbranding or adulteration of the Neurotris SX-Series Machines and PICO Toner, such as the commercial distribution of the devices for the uses discussed above.

For the consultant there are a few issues to consider. First, this is an opinion offered at a point in time. If the manufacturer’s marketing department wishes to later make claims outside the initial intended use, then that should negate the consultant’s opinion.

In preparing a written opinion, there are a few basic elements.

Cite the Product Code and all the information from the classification page. A screen shot showing the date is best, because FDA could make changes later.

Cite the regulation and all of the relevant sections. Include the FR citation to help nail down the version cited. (Unlike other documents, the Federal Regulations don’t have a version number.)

Obtain a copy of the manufacturer’s intended use statement. Insist that the manufacturer have it under document control and readably accessible. Cite the version including the document number and revision. Remember that during the design phase, the manufacturer could use an informal document control system. For most Class 1 devices, design control doesn’t apply. In any case, include the full statement of the manufacturer’s intended use.

Review the xxx.9 section of the regulation. Make a table of the limitations in one column, in the next column a statement of whether or not the intended use satisfies the limitations, and in the last column the rationale for your conclusion, citing the manufacturer’s intended use statement.

As a regulatory professional, what do you need in order to feel comfortable with the determination that a device is a Class I device that is 510(k) exempt?