Clarifying FDA definition of "finished device" and “capable of functioning”

outdoorsNW

Quite Involved in Discussions
#1
We are an electronics contract mfg., high mix, low volume. We are looking at targeting medical electronics companies. We are at an early stage and am trying to determine where we may need to hire outside experts and what we should avoid until we have a better understanding of the requirements.

For the moment I think we should avoid producing “finished medical devices” because of the added regulatory requirements. However the definition of what is a finished medical device leaves room for interpretation.

From the FDA regulations: “820.3 Definitions. (l) Finished device means any device or accessory to any device that is suitable for use or capable of functioning, whether or not it is packaged, labeled, or sterilized.” [Emphasis added]

How is “capable of functioning” defined?

When I searched both the web and elsmar, I did not find anything clarifying this.

For instance, with an electronic item, the device may have been fully assembled but not tested. If you have a good customer design and a good manufacturing process, an untested device usually will be fully functional. If the design responsible customer is responsible for final testing, is this considered “capable of functioning” when we send it to our customer?

What if the scenario changes and the device needs calibration or some other setup before use, but may function with reduced performance, such as reduced accuracy?
 
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monoj mon

Quite Involved in Discussions
#3
How is “capable of functioning” defined?
Let me give you a simple example. Suppose you manufacture a suction liner which is suitable as an accessory to any manual or electronic suction device. If you manufacture every single component of the suction liner and assemble it at your facility, it will be considered as the finished device. Because, in that form anyone can use your suction liner to fit it with any type of suction device. However, if you just manufacture the fluid containing part while rest of the parts (such as the lid, tubing etc.) are manufactured by some one else and all the components are sent to your client's company for assembly then none of the third party manufacturers are considered to be manufacturing a "Finished Device" as the individual components can not be used by anyone as a "Device".
For instance, with an electronic item, the device may have been fully assembled but not tested.
In your case, as you have said, you fully assemble the device. That means, anyone can pick your product and attempt to use it as a "Device" (refer to the FDA's definition of device) which would mean that your device is "Capable of functioning".
If the design responsible customer is responsible for final testing, is this considered “capable of functioning” when we send it to our customer?
No, that is not what it means by "capable of functioning". It means, the product can be used as intended even though it fail and harm the patient.
What if the scenario changes and the device needs calibration or some other setup before use, but may function with reduced performance, such as reduced accuracy?
Exactly, if anyone can pick your device and perform the intended use even though with reduced accuracy or failure, still your device will be considered "capable of function".

This is why, it is important for the third party manufacturer of "finished device" to register and list the device with the FDA. Registration and Listing will make FDA aware of your existence and ultimately your facility will be inspected in the future.
 
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