Mandatory wording of Intended Use

[PL.]

Hello,

Does anyone know that whether or not could we removed the following sentence in the wording of intended use if our glucose meter is intended for both home and professional use? “it should not be used for diagnosis of diabetes”

And, is the sentence mandatory in FDA? what if our device is only for home use or only for professional use, then what will that be (can we remove the sentence in those two cases?)

Many thaks!!

 

[MIREGMGR]

Re: Mandatory wording of intended use.

1. Blood glucose monitoring systems require a 510(k). No change may be made to the labeled intended use of a 510(k) cleared device without first obtaining approval for that change via a Special 510(k). If that statement was included in the original 510(k), and the original 510(k) allowed marketing to either professional or lay users, that statement must be there until/unless a change is FDA approved, irrespective of whether the device is marketed to professional or lay users, or both.

2. No meter or similar device can "diagnose" anything. Licensed practitioners do diagnosis, because diagnosis is the practice of medicine. BCMSs are used to measure the status of a biological parameter. A particular meaning can only be assigned to the measurement values by such a practitioner. My guess would be that if you market a device as allowing a lay person to make a "diagnosis", FDA will regard that as unacceptable.

 

[Ronen E]

Re: Mandatory wording of intended use.

Hi,

From the sum of relevant guidance that I've been able to track down, it's clear that FDA doesn't endorse POC BGM utilization for purposes of Diabetes diagnosis. However, I didn't see an explicit requirement for an exclusion statement (or contraindication) in the labeling. Such statements do appear in some BGM 510(k) summaries that I've seen (maybe yours?). perhaps this practice comes from ISO 15197 - I don't have it so I wouldn't know.

I agree that removal of a contraindication from the cleared labeling most likely calls for a special 510(k).

Cheers,
Ronen.