Anon,
You use the phrase, '... and possibly use on cases' which would indicate the finished device would be used with a human patient. If such is the case, then would recommend treating this like any other finished medical device, i.e. DofC, listing, license, etc. Sample or demo sets are often sent to customers or potential customers that are not considered a finished medical device because they are not intended to be used with the patient - more a "show and tell" type. Indeed if the device can be used with or on the patient, then it should be considered a finished medical device with all the requirements implemented.
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Richard Vincins RAC
Vice President Global Regulatory Affairs
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Original Message:
Sent: 15-Jul-2019 10:01
From: Anonymous Member
Subject: Dental DEMO SET
This message was posted by a user wishing to remain anonymous
Hi,
We are planning to ship Demo Sets of dental zirconia discs with shading liquids to laboratories to try out and possibly use on cases. Each of the individual devices and/or accessories in the Demo Set has a 510(k), is listed with the FDA, has everything for the CE, and Health Canada.
Do we need to list the name of the Demo Set on the Declaration of Conformity, list the Demo Set with the FDA, add the Demo Set to our existing license with Health Canada, etc...?
Thanks in advance