We are a medical device company that sells to US, EU, and Canada, and we are ISO 13485 registered so we have to comply with regulations/standards from each country and Europe.

I was reviewing our own internal procedures for labeling and traceability and labeling is defined as including packaging labels, box labels, instructions for use, and marketing literature. I did not create the original document, so I am not sure why marketing literature is included as being under the labeling procedure. Furthermore, within the procedure, it states that the approval and sign-off of Marketing Literature and the company web site is the responsibility of the Director of Marketing and the Executive Director of our company. This is not being done.

So I just wanted to verify that there is no national or international requirement to include marketing literature as part of our product identification. The only thing that comes close to this is EU MDD 93/42: Annex 1: Section 13.1: third paragraph that states that information needed to use the device safely must be set out on the device itself or where it is appropriate on the "sales packaging."

Thank-you!!
Emily Madsen

The FDA includes all product-information-communicating materials provided with a product, and generally all advertising (which includes all marketing-communicative channels, i.e. websites, verbal communications, etc.) as "labeling".

See http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/DeviceLabeling/default.htm.