Goodmorning all, I have a question about the use of the IVD symbol on in vitro diagnostic products in USA. The IVD symbol as defined in ISO 15223 standard should be used to indicate “a medical device that is intended to be used as an in vitro diagnostic medical device”. Then the restriction says: “This symbol should only be used to identify in vitro diagnostic medical devices and not to specify that the medical device is for in vitro use”. So my interpretation of this restriction is that for US market I cannot use this symbol to indicate that a devece is for in vitro use, unless it is also an IVD according to 98/79 EU directive. I should state on labeling “for in vitro use”, without the symbol.
Can anyone working in USA market tell me something more/different about the use of this symbol?
thanks,
Luisa

source: https://www.linkedin.com/groups/2070960/2070960-6103199606147989508