Medical Device FDA - Classification of a device used as an interface with a computer

R

RickRay

#1
Here is my question. If we design a device that is used as an interface with the computer and displays that are used by a nurse or doctor, does this device need to be registered as a medical device?
Also, if so where does ISO 13485 come in at? This is not a requirement for a manufacturer correct? Or is it a requirement when you plan on expanding your market overseas?
In addition, if it is designed out of the US and we only build it and ship it, does that make it any different?

Thanks,

Rick
 
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Ronen E

Problem Solver
Staff member
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#2
Re: Medical Device FDA - Classification of a device used as an interface with a compu

Here is my question. If we design a device that is used as an interface with the computer and displays that are used by a nurse or doctor, does this device need to be registered as a medical device?
Also, if so where does ISO 13485 come in at? This is not a requirement for a manufacturer correct? Or is it a requirement when you plan on expanding your market overseas?
In addition, if it is designed out of the US and we only build it and ship it, does that make it any different?

Thanks,

Rick
Hi,

First, the answers to your questions depend on the market(s) into which the product is sold.

In European terms, it sounds as if this device could be an accessory to a medical device, in which case it is subject to most requirements applicable to medical devices (CE marking, registration etc.). In this case ISO 13485 is relevant, though formally it is not mandatory. It is a harmonized standard and therefore compliance certification will establish presumption of meeting the relevant essential requirements (part of the CE marking process).

ISO 13485 certification may come in handy in other territories as well, and in some it IS mandatory (not in the USA though).

In the main regulatory systems (EC, USA etc.) the regulatory responsibility lies with the legal manufacturer, which is not necessarily the actual one. This relates to ISO 13485 certification and other regulatory obligations. The legal manufacturer is the one identified on the labeling as placing the product onto the market (the labeling may also identify the actual manufacturer, if different, and/or the distributor... could be a bit complicated, I know :)). If you design and someone else makes it for you (under your own label) you are still the legal manufacturer - in FDA terminology this is referred to as a "specification developer" / "contract manufacturer" arrangement. By the way, although the contract manufacturer is not directly regulatorily responsible for the device in such an arrangement, it is subject to certain regulatory requirements as well.

The opposite applies as well - if someone else designs it and you only make it, then they may be the responsible entity. It all depends on the labeling. Regarding specific regulations that relate to the geographical location of the designer / maker, this should be examined in light of the specific territory into which the device is introduced, and its regulatory system. If you wish to provide specific details regarding your case, rather than discussing various possible general scenarios, then more definite answers can be provided.

Either way, good luck!
Ronen.
 
M

MIREGMGR

#3
Re: Medical Device FDA - Classification of a device used as an interface with a compu

Here is my question. If we design a device that is used as an interface with the computer and displays that are used by a nurse or doctor, does this device need to be registered as a medical device?
I agree with Ronen E's comments.

Additionally:

Whoever is regulatorily responsible for the device is responsible for design control and validation, whether they or someone else actually performs that work.

The intended use of the product will bear on whether it's a device in a particular jurisdiction; device status may not be consistent on an international basis; and classification and thus the degree of regulatory oversight and governance also may vary internationally.

A product like this, if it's a device and if its classification is such that it is subject to significant regulatory oversight (for instance, in the US, a 510(k) premarket filing requirement), may be subject to a number of other standards that must be considered from first product conception and design.
 
R

RickRay

#4
Re: Medical Device FDA - Classification of a device used as an interface with a compu

Thank you guys!

Maybe once I have a more clear understanding of exactly what I am being asked, then I will have a more specific line of questions. But the answers provided help a lot.

:thanks:
 
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