21 CFR Part 820.30 Design Controls for Class 1 Medical Device

T

tobynz

#1
Hi All
I need help in deciphering a requirement.
According to section 820.30(2), class 1 devices are subject to design controls when sub item 1 "Devices automated with computer software" is met.
We have a device that uses embedded software but no automated decisions are made by the software - all commands are initiated by the user. A legal consultant has advised that we do not need to meet the design control section of the QSR but I am unsure on the definition of ''automated with computer software'. Has anyone else run up against this definition :confused:

Edit - does this rule apply design controls to the entire device or just the development of the software within???

Cheers
 
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sagai

Quite Involved in Discussions
#3
Is the regulation saying automated decision made by the software?

So, what justification was provided by the legal advisor in this case?

"shall establish and maintain procedures to control the design of the device "
It is not really saying "the software part of the device".

Cheers!
 
M

MIREGMGR

#4
According to section 820.30(2), class 1 devices are subject to design controls when sub item 1 "Devices automated with computer software" is met.
does this rule apply design controls to the entire device or just the development of the software within???
My understanding, from the literal wording, is that the design control requirement applies to the "device", not just to the software.

We have a device that uses embedded software but no automated decisions are made by the software - all commands are initiated by the user. (...) I am unsure on the definition of ''automated with computer software'.
My understanding is that "automated" in this context means that software provides the virtual linkage between Button X Pushed and Action Y Implemented.

I'm quite sure from the distributed historical record that FDA didn't intend that terminology to refer solely to (wholly or partly) autonomous decision making. I'm not a medical-device-controls expert, but when FDA first implemented that requirement, a relatively tiny proportion of medical devices was autonomous-decision-capable. My understanding from the history is that FDA's intent was to regulate the more common case of designs with software-virtual-linkages.
 

sreenu927

Quite Involved in Discussions
#5
I totally agree with MIREGMGR on the interpretation of "automated".
We too have a simple device that has embedded SW (Firmware) and we apply design controls during its design and development.

Regards,
Sreenu
 

Aphel

Involved In Discussions
#7
Hello,

What we have learned about that topic during the preparation of our quality system or QSR compliance was...

Even if QSR says design controls do not apply for class 1 devices (excluding some special devices and software-automated devices)...the manufacturer should use the design controls at least as a "guidance"...

Further more - the regulation talks about "medical devices" automated with software.
The embedded software in your case - is not a medical device, it is an integral part of your device.

Best regards.
 
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