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Software contained in a Medical Device Accessory

A

andreasm

#1
Hello,
I'm helping a MD manufactoring company with SW regulations as part of my thesis project. In the current project, a robotic prosthetic is being developed which uses SW to control the prosthesis based on the users intent (through biosignals).
As it is a small company, we are looking into seperrating the physical device into an implanted part, and then classify the external attachments as MD accessories to reduce the amount of resources we need to spend on getting an FDA approval.
The controlling SW will be embedded into one of these attachments. My question is if there is any special regulations to concider if the sw is inside a MD accessory?
My guess is that the sw would not be affected by this but I wanted to seek confirmation, and these forums have been very good so far :)

As a side note, the sw itself will be developed in conformance with the IEC 62304 standard and based on the preliminary RA, it will be a Class B sw.

Thank you for your help :thanx:
 
#2
Sorry, but the external part would still classify as a medical device.

And if you have an implanted part that would elevate the FDA requirements to a 'Class 111' which, in turn, means having to get PMA (rather than 510k) clearance.

For European clearance you would be governed by the Active Implant Directive (90/385). This would require full design review by your Notified Body, rather than quality control plus technical file review.
 
A

andreasm

#3
Thank you.
I suspected as much. We have already concluded that the medical device would be a Class III according to the FDA due to the implanted part, the question was just whether it would be possible to classify them differently and if this would somehow affect the software. Trying to avoid doing redundant work as the resources are limited.
For the EU, it would seem that we could classify the implanted part as the 'medical device' while classifying the external attachment part as an 'accessory'.
From what I can tell, however, this will not affect the software classification in anyway as it is classified separately in accordance with IEC 62304.
 
#4
For the EU, it would seem that we could classify the implanted part as the 'medical device' while classifying the external attachment part as an 'accessory'.
From my experience the external part was also thought of as part of the medical device.

The distinction is not very useful as accessories are regulated in the same way as the device they are intended to be used with.
 
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