Can we take a part from 510k cleared medical device and use it in class I device?

N

Nissim Shaked

Shaked
#1
#1
We are planning to take part of an already 510k cleared device (its energy converting part=motor)
to drive a new class I (510k exempt) device?
The new device shall undergo risk analysis, design input and V&V full testing for making 100%
sure it is safe for use and perform its intended use properly.

Do we mis any regulatory requirement which restrict us to do such a combination?
 
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Watchcat

Watchcat

Trusted Information Resource
#2
#2
There is no regulatory requirement that prohibits you from doing this. The regulatory requirements and restrictions kick in when you put a medical on the US market.

Perhaps what you meant to ask is whether you can reasonably claim that the "new" device is a Class I device, and, if so, that the "new" device is also 510(k) exempt. That depends on whether or not it is substantially equivalent to a predicate device. The answer to this question has nothing to do with where the motor came from. It might or might not have something to do with the regulatory status of the device in which the motor will be placed.

To answer this question, I strongly recommend that your company hire a regulatory specialist who is knowledgeable in FDA regulation of medical devices, or secure the services of a regulatory consultant who is knowledgeable in the FDA regulation of medical devices.

This is not a good fit for me, but there are several consultants in this forum with this expertise.
 
N

Nissim Shaked

Shaked
#3
#3
Watchcat said:
There is no regulatory requirement that prohibits you from doing this. The regulatory requirements and restrictions kick in when you put a medical on the US market.

Perhaps what you meant to ask is whether you can reasonably claim that the "new" device is a Class I device, and, if so, that the "new" device is also 510(k) exempt. That depends on whether or not it is substantially equivalent to a predicate device. The answer to this question has nothing to do with where the motor came from. It might or might not have something to do with the regulatory status of the device in which the motor will be placed.

To answer this question, I strongly recommend that your company hire a regulatory specialist who is knowledgeable in FDA regulation of medical devices, or secure the services of a regulatory consultant who is knowledgeable in the FDA regulation of medical devices.

This is not a good fit for me, but there are several consultants in this forum with this expertise.
Click to expand...
Thank you for the information
 
D

duinyk

Involved In Discussions
#4
#4
I had a similar question.
If you intend to bring a class II 510k exempt to the market, could you use or classify the device with two 510k exempt codes from two different regulation numbers?
 
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