Regulatory Open Forum

Hi All,

I have a device which is Class II SaMD - FDA and while I write the intended use/indications, the main indications has been studied in a clinical study using primary endpoints and powered, I have also evaluated a feature of the device using a secondary endpoint not powered. I understand the feature studied as a secondary endpoint cannot become part of the indication. But have the following doubts:

• While I market the device can we market saying that the device has also been tested in so and so features (secondary endpoint features)?
• Can the end user use it for the additional feature in clinical practise?

I would greatly appreciate any advice on this regard.

Thanks!

In a nutshell, ALL of a manufacturer's advertising/promotional statements must be within the boundaries established by the FDA-cleared/approved intended use and indications. Consequently, if a manufacturer makes claims that the subject device has been tested for, or can be used for, features not directly within the boundaries established by the FDA-cleared/approved intended use and indications, then that generally misbrands the device by way of marketing for uncleared/unapproved indications.

The FDA doesn't generally prohibit clinicians from using their clinical judgment/expertise in the use of medical devices outside of the manufacturer's labeled intended use / indications.  Clinicians are allowed to decide whether such "off-label" use is in their patient's best interest.

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Kevin Randall, ASQ CQA, RAC (U.S., Europe, Canada)
Principal Consultant
Ridgway, CO
United States
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