How to document a Patient Outcome claim for a Class I device?

K

kongde

#1
My company markets a Class I medical device. If we want to claim (in marketing material) that our device improves patient outcomes, what sort of data or documentation is required to back up that claim?

All the clinical study guidance on the FDA website seems to be geared toward higher class devices. Thanks for your help.
 
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M

MIREGMGR

#2
Re: Performance claim on Class I device

A claim is a claim. There are no lower standards for FDA Class I devices.
 
J

Julie O

#3
Re: Performance claim on Class I device

You have to have data that shows it improves patient outcomes. I'm not sure exactly what you are asking. Are you asking if you need to conduct a study?
 
J

Julie O

#5
Re: Performance claim on Class I device

A claim is a claim. There are no lower standards for FDA Class I devices.
The "standard" is simply that you need to have data that are adequate to support your claim.

kongde is probably correct that FDA's clinical study guidance is geared toward higher risk devices, because manufacturers of Class I devices rarely have to conduct a study to meet this standard. There is usually enough clinical data already available to support the claims, usually in peer-reviewed publications. The data usually do not need be data collected with your specific device (although that would be very nice), but could be data for any device that falls under the same classification regulation/product code. In this case, the EU guidance on Clinical Evaluation Reports (MEDDEV 2.7.1) might be a better guidance, if you can make sense of it, which I am still working on, all these years later.

If no such data exist, then that's unusually bad luck for a Class I.

In that case, a clinical study may be necessary, and the information in the existing guidances regarding protocol design, sample size justification, monitoring, data analysis, etc, would indeed apply equally to Class I, at least in theory. In practice, FDA's expectations will usually be somewhat lower across the board. This is because it is a low-risk device, and the reasons FDA classified it as low risk in the first place will usually be reasons that FDA will feel more comfortable with a less robust clinical trial than it would be looking for to support claims about a Class II or III device.
 
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mihzago

Trusted Information Resource
#6
be careful about making the claim that you do not cross the boundary of your clearance. I don't know what your device is, so my comment may not apply but Class I devices typically have very broad indications for use. So when you make an outcome claim in relation to a specific condition it may push you outside the classification/product code your product is in.
 
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