From: Rob Laport [laport.r@future-diagnostics.nl]
Sent: Thursday, October 30, 2003 5:44 AM
To: fdadockets@oc.fda.gov
Subject: docket number 2003D-0383

L.S.,

Heaving read the draft guidance for Industry and FDA Staff: "Use of Symbols on Labels and in Labeling of IVD Devices Intended for Professional Use", I was left with this question:

How is the FDA's current thinking about the use of other symbols (i.e. other than the 25 in the list), provided that the symbols are explained in the accompanying test instructions?

The reason for this question is that for different products more symbols are needed than the 25 listed. The list does for example include a symbol for controls, but not a symbol for standards or calibrators, etc. The result is that, if other symbols are not recognized by the FDA, still much text has to be added in all the required European languages or, alternatively, that separate American and European labels have to be produced (which is undesirable, as clearly outlined in the draft guidance).

Looking forward to your answer,

Best regards,

Rob Laport
QA Manager
Future Diagnostics B.V.
Wijchen, the Netherlands