G
Gaby
Hello,
For a unit which 510(k) has both the "Prescription Use" and the "Over-The-Counter Use" checked on its 510(k) summary - how is the labeling supposed to be handled?
- one set of artwork for the OTC unit ... a version without Rx functions enabled or claimed?
- a separate set of artwork for Rx unit ... a version with Rx functions enabled and indicated on labeling?
I wouldn't think so.... but assuming one single set of artwork can be used, I guess the restrictions with respect to the Rx functions must be addressed via labeling?
How would sales be controlled then, being that there are certain functions cleared under prescription only? Could we sale it OTC even if marked Rx?
Thanks in advance.
Gaby
For a unit which 510(k) has both the "Prescription Use" and the "Over-The-Counter Use" checked on its 510(k) summary - how is the labeling supposed to be handled?
- one set of artwork for the OTC unit ... a version without Rx functions enabled or claimed?
- a separate set of artwork for Rx unit ... a version with Rx functions enabled and indicated on labeling?
I wouldn't think so.... but assuming one single set of artwork can be used, I guess the restrictions with respect to the Rx functions must be addressed via labeling?
How would sales be controlled then, being that there are certain functions cleared under prescription only? Could we sale it OTC even if marked Rx?
Thanks in advance.
Gaby