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:
I would greatly appreciate any advice on this regard.
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.
------------------------------Kevin Randall, ASQ CQA, RAC (U.S., Europe, Canada)Principal ConsultantRidgway, COUnited States© Copyright 2023 by ComplianceAcuity, Inc. All rights reserved.------------------------------
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