Definition Commercial Distribution - Definition - Scope of Commercial Distribution

[funkgirl]

Hi! I am trying to find confirmation that the definition of "commercial distribution" in 807.3(b) includes devices for human use that are sold, provided at no-charged and/or loaned to a customer?

One of our R&D staff seems to believe that full design validation isn't required if the device will initially be provided to a small number of KOLs for free, with the intent that the devices be used on humans. This is not a clinical study and there is no IDE - it's a limited market release.

Please help me put this madness to bed!

 

[yodon]

Regulatory isn't my thing but I'll reply and maybe stimulate some other responses.

It sounds to me like you're distributing a medical device. (And that's a "Period!" with appropriate emphasis). Thus, you should meet all the requirements of the Quality System Regulation. I don't see how that could be interpreted otherwise. To me, you should only provide the devices if you conduct all the efforts required to clear your device for distribution (e.g., 510(k), PMA, etc.).

Consider the ramifications if an adverse event occurred with one of the individuals using it.

Instead of asking your R&D staff, I'd suggest consulting whomever you have for regulatory.

 

[funkgirl]

Thanks!

I AM Regulatory, but there is a particular R&D person who constantly argues with me about regulatory requirements - particularly design controls. For some reason, he feels that my 20 years in the industry and Masters in RA doesn't seem to trump his PhD in Chemistry with no prior device manufacturing experience, so every single project is a battle to force him to do things properly.