Labeling for Medical Device Samples - Surgical instruments

Hi ,

We are going to send surgical instruments as sample as to be evaluated by the costumer. Some may need 510 k but how should we label them to indicate "not for clinical use" or " not used on humans", "not for commercial distribution" ? Is it enough to mention it on the paper sticker label or, do we need to engrave it on the medical device also?

Thank you very much in advance

A label such as "Sample Only. Not for human use" is a must. If your device is reusable I would recommend engraving that on the device itself to be on the safe side, even though I'm pretty sure there is no specific requirement for reusable demo units.

Shimon

Thank you for your answer Shimon.

I have one more question. Do samples have to return the country or can ben send as promotion for good? I mean what is FDA procedure.

Zeynep

A demo/promotional material is not a medical device and usually does not return to sender. After all, its free...
That is way I suggested to engage the labelling on the device if its reusable - to assure it won't be used on humans or misused in any other way.

Shimon

Hi, what about if we ship samples for biocompatibility test? Do we need to label "Sample only. Not for human use." too?

Dear Mr. @shimonv

I would like to seek clarification regarding our company's practice of distributing free samples of auriculothérapie needles to customers upon request.

We provide these samples at no cost to interested individuals, however i am uncertain about whether it is necessary to assign a basic UDI-DI to these test boxes, which we refer to as samples. FYI these test boxes were not included in MDR application Appendix that we alrady sent to our NB.

Thank you in advance.

Do you label them as "Not for human use"? Are they intended for trying out on a person or just as a demo?

If they are for use on a human, regardless of how much money you charge for them, you need to treat them as a medical device and label/approve accordingly, including BUDI.

Also is possible to use serial numbers. During my time the Dept of Veterans Affairs surgeons were notorious for trying a device and then putting it aside to try a different one. We would submit 10 and get 9 back. FDA had issues when we could not find that one so we had to search everywhere for it. So S/N and traceability were required. This was for a High risk IDE FDA-approved clinical study though. For something the IRB deems lower risk, less control may be required.

Having said that. surgeons are generally permitted to use tools "at their discretion" as they see fit. There was an operation for wrapping a nerve bundle. No such tool existed so they decided of their own volition to use existing tools in their surgical protocols.