Investigational Testing - Does the Medical Device have to be "sold"?

[Mark Meer]

Just wondering:
Part 3 (Medical Devices for Investigational Testing Involving Human Subjects) of the Canadian Medical Device Regulations, SOR 98/282 states:

79 This Part applies to medical devices that are to be imported or sold for investigational testing involving human subjects.

What if you are lending a prototype device for the purposes of gathering data/user-feedback? No money is changing hands, and the facility is based in Canada, so no importation.

Does these regulations still apply? If not, what are the requirements for the case I've described?

 

[shimonv]

Hi Mark,
It seems the regulator did not address your specific circumstances. BUT we know that Regulatory Affairs in not about money but safety and effectiveness. Section 80 describes the requirements for investigation testing based on the risk level. I think you should follow these guidelines and ignore the financial element. Furthermore, the phrase "imported or sold" doesn't mean that financial transaction is always present.

That is my opinion.

Cheers,
Shimon

 

[Mark Meer]

I think you should follow these guidelines and ignore the financial element. Furthermore, the phrase "imported or sold" doesn't mean that financial transaction is always present.

I agree, this is the most conservative approach.

...and yet if this is indeed the intent, why obfuscate with language like "sold" (which to me, does involve a financial transaction)?

Instead of
"...applies to medical devices that are to be imported or sold for investigational testing..."
why not state instead:
"...applies to medical devices that are to be used for investigational testing..."

It doesn't make any sense to me why you'd throw in "imported" or "sold", if the intent is to ignore the financial element.

 

[Miner]

This is where the less common definitions of a word can come into play.

While most people understand "Sell" in terms of a financial transaction, it can also mean "Make available for sale", actual completion of a transaction not required.

 

[Mark Meer]

Agree. But in this context it still makes no sense - except to cause confusion.

Whether we're talking "sold for investigational testing", or "made available for sale for investigational testing" doesn't really make a difference to my initial inquiry.

We could assume, for the sake of argument, that the device is NOT available for sale, and NOT imported. You are simply lending a prototype of a device that has yet to be marketed to an investigator so that he/she can carry out an investigation.

If the regulations are intended to cover such cases, I don't see any reason why the scope would not have just been worded simply as "...used for investigational testing...". Seems strange, and unnecessarily confusing, to specify importation and sale in the scope...

 

[RA Guy]

Mark, sorry to reply on a bit of an older thread, but "sell" is defined in the Food and Drug Act:
"sell includes offer for sale, expose for sale, have in possession for sale and distribute, whether or not the distribution is made for consideration;"

In the case of investigational devices this definition contrasts internal R&D testing from handing devices over to 3rd party PIs for use in clinical studies (distribution). An IRB may still be required for internal studies involving human subjects, but Health Canada does not require an ITA to do so. 

 

[Mark Meer]

Mark, sorry to reply on a bit of an older thread, but "sell" is defined in the Food and Drug Act:
"sell includes offer for sale, expose for sale, have in possession for sale and distribute, whether or not the distribution is made for consideration;"

In the case of investigational devices this definition contrasts internal R&D testing from handing devices over to 3rd party PIs for use in clinical studies (distribution). An IRB may still be required for internal studies involving human subjects, but Health Canada does not require an ITA to do so. 

Thanks for the reply! ...but I apologize, I'm still struggling for clarity...

On the one hand, you seem to be indicating that just giving/lending an investigational device to a 3rd party for testing purposes IS considered "sale" (because the definition includes "have in possession for sale and distribute"?), but then say Health Canada does NOT require an Investigational Testing Authorization (ITA) in such cases?

...but isn't that what section 89 requires?
"83 (1) The Minister shall issue an authorization referred to in subsection 80(2) to a manufacturer or importer if the Minister determines that..."

I appreciate the F&D Act definition, but I'm still confused as to why the regulations would be written with "sell" if what they actually mean is "distribute", or "use"...

 

[RA Guy]

Hi Mark:

ITA not required for internal to company clinical studies as a manufacturer does not distribute to themselves. This is the scenario where an ITA is never required, but IRB approval is.

I agree that the use of "sell" is overly broad and as a result often misunderstood. I tend to think of it as any transfer of possession to an external party for the purposes of performing investigational testing on human subjects, even if the transfer is temporary.

Why the word "sell" was landed on to include all of the regulated activities is something I can't tell you.