Change Medical Device Class from Class II to Class I

One of our products received a 510K Clearance as a Class II device (about 5-years ago). However, after reviewing the product's "use model" and researching the product codes/reg numbers and other how other companies listed the device, I found that the device was registered with an incorrect product code/reg number; the correct product code/reg number would make it a Class I Exempt device.

Is there a way to downgrade a device's classification to Class I from a Class II 510K? Do I just "inactivate" the device's listing and re-add the product as a Class I device? Or is more required?

Would the device have been considered class 1 exempt when the 510(k) was filed?

Yes the device would have been a Class I Exempt when filed.
The person who filed it made a mistake in classifying the device.

I would say this goes beyond any mis-steps the person who filed it made.
Assuming this was a traditional submission and knowing that it was cleared within the last few years, I am surprised that this issue never came up during the 510(k) review.

I think in the end you will need to discuss with FDA and try to get something in writing. If it’s true that you are class 1 great. If not, I would not want to be in front of an FDA inspector explaining how I self determined no longer needing to apply GMP (assuming that the class 1 designation you have in mind is GMP exempt) or why you did not apply the "When to Submit..." guidance based on a class 2 determination without having this conversation. The current 510(k) seems too difficult to ignore.

Going to FDA seems somewhat risk free as the worst case is that they confirm you are class 2. You already have the clearance.

I am curious what you mean by "reviewing the product's use model". Is it possible that you are marketing the device with a "lesser" intended use than originally cleared or that users are applying it in a narrower way? A change in intended use could push it down a class.

Definitely an interesting question though.

The intended use of the device was always narrow. I have found that our supplier registered the same device as a Class I and I found that others have also.

I have reviewed the "Deciding When to Submit a 510(k) for a Change to an Existing Device". While it suggests submitting a new 510K if the "indication of use" changes, it doesn't state if there is a process for withdrawing a 510K or how to reclassify a device as Class 1 510K Exempt.

Was hoping someone here had experience with this scenario.

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I thank you for the help you have provided.

It appears these two forms need to be completed when reclassifing a Medical Device:
- FORM FDA 3429 GENERAL DEVICE CLASSIFICATION QUESTIONNAIRE
- FORM FDA 3427 SUPPLEMENTAL DATA SHEET

"These forms address the safety and effectiveness of the products.
Scientifically valid evidence supporting manufacturers’ arguments that reclassification of their devices will uphold safety and effectiveness is also required."

RA Guy said:

I would say this goes beyond any mis-steps the person who filed it made.
Assuming this was a traditional submission and knowing that it was cleared within the last few years, I am surprised that this issue never came up during the 510(k) review.

I think in the end you will need to discuss with FDA and try to get something in writing. If it’s true that you are class 1 great. If not, I would not want to be in front of an FDA inspector explaining how I self determined no longer needing to apply GMP (assuming that the class 1 designation you have in mind is GMP exempt) or why you did not apply the "When to Submit..." guidance based on a class 2 determination without having this conversation. The current 510(k) seems too difficult to ignore.

Going to FDA seems somewhat risk free as the worst case is that they confirm you are class 2. You already have the clearance.

I am curious what you mean by "reviewing the product's use model". Is it possible that you are marketing the device with a "lesser" intended use than originally cleared or that users are applying it in a narrower way? A change in intended use could push it down a class.

Definitely an interesting question though.

Click to expand...

Just to mention something probably already known -

Class I classification does not automatically confer GMP (QSR) exemption. The specific code's requirements should be reviewed to confirm relevant exemptions (as well as review of the exemption conditions, such as those in part XXX.9). Most class I devices are design controls (part 820.30) exempt, but even this rule has exceptions.

Cheers,
Ronen.

I agree with the prior advice. But, as to what to do practically speaking, since you're in California you can just pick up the phone and call DSMICA and ask your question.

No doubt they won't have the answer, since it's almost certainly a managerial-level, specifics-of-instance-dependent issue. But they'll probably refer you to someone specific within FDA, who will tell you what information they want from you in writing, and that'll be the actual process for eventually getting a determination.

Thank you and everyone else for answering my questions.
I have learned much from this site.