Bringing Medical Device Prototypes into the US

[qmvpma]

Hi,

we are currently developing a class II medical device in europe. To performe some validation tasks, we would like to bring 5 devices to the us.
Are we allowed to just put them in a suitcase and fly to the us or are there any regulation regarding medical device prototypes?

We are planning to start a 510 clearance next year.

thanks in advance

 

[Ronen E]

Hi,

What sort of validation tasks do you plan to carry out in the USA?

 

[MIREGMGR]

Hi,

we are currently developing a class II medical device in europe. To performe some validation tasks, we would like to bring 5 devices to the us.
Are we allowed to just put them in a suitcase and fly to the us or are there any regulation regarding medical device prototypes?

US FDA regards any product that can perform a medical device function as a regulated device, irrespective of whether you regard it as a prototype. A medical device brought into USA is subject to regulation by both FDA and Customs and Border Protection (CBP).

There is a specific exception-category for investigational devices intended to be used for clinical trials and safety-and-effectiveness validation: the Investigational Device Exemption (IDE) program.

See this link and the provided index for further information.

It's not a particularly simple course to follow, but it's the legal way to bring prototype devices into USA if you aren't ready to subject them to full regulation.

A non-Listed, non-IDE medical-device-like product detected at the border by CBP would be subject to seizure.

 

[Julie O]

I'm wondering what definition is being used that makes this Thing a medical device?

In my lexicon, if it's a prototype, it is by definition not intended to be used for any of the purposes listed in the FDA's definition of a medical device. That is, if it really is a prototype, rather than an investigational device, which makes Ronen's question a good one, given that a pivotal trial is a form of design validation. But there are other types of validations that are not clinical trials.

Not disagreeing with anyone's answers here, just asking. My personal lexicon has yet to be universally adopted.