From 21 CFR to IEC 60601 - Please explain

#1
Hello, I look forward to many great discussions on this forum. I wish I had known about it years ago!

I am an electronics engineer and have been through the process of getting a new device through 60601 safety and EMC testing a few times.

But now I am involved with a very small startup company in the USA, and in addition to the safety and EMC, I am responsible for generating the risk analysis/management paperwork, which I have not had to do in the past projects. I might be able to delegate it to a junior engineer if I know exactly what needs to be done, but its a bit new to me.

I like to know why I am doing what I am doing, even if its somewhat academic. So in this case, I'd like to know where the actual requirement to follow IEC 60601-1 comes from.

From what I've researched I think it goes:

21 CFR (Federal law)
has a 8xx section which directly lists our device type
In that section, says that an approved consensus safety standard must be applied, of which, 60601-1 is one of them.
I've noticed some 8xx sections directly mention 60601.

Is that correct? I'd really like to know exactly what the linkage is. I would make an assumption that exactly what "version" of 60601-1 to follow depends a bit on company/marketing strategy as far as where the device will be sold, is that true?

What is the difference if my device did not have its own "subcategory" 8xx section, what would I follow then? Is there a generic section which acts as a catch all?

Or what if my device technically has a subcategory, but its under a main category that would not apply? For instance, there is an "Anesthesiology" upper category with 8xx subcategories that describe our device very well, however our device is not Anesthesiology related in any way. Would we still use those 8xx categories that seem to describe it?
 
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yodon

Staff member
Super Moderator
#2
Can't let a first-time post go unanswered! (Welcome!)

I think you're at least on the right track. That's at least my understanding. I don't know, though, if there's no specific device category if a parent category is applicable. I'm not sure how your device would fit an anesthesiology category without being related to anesthesia.

Hopefully this will get the discussion moving.
 

shimonv

Trusted Information Resource
#3
Hi thirdplanet,
By way of a brief introduction - Class II devices require general controls and special controls. General controls are the common ground for most products. For example, QMS, UDI and adverse events reporting.
Special controls are required for devices where general controls alone are insufficient to provide reasonable assurance of the safety and effectiveness.
Special controls include performance standard, special labeling requirements, etc.

The specific device types listed in the 8xx series require special controls (in addition to general controls).

21 CFR (Federal law)
has a 8xx section which directly lists our device type
In that section, says that an approved consensus safety standard must be applied, of which, 60601-1 is one of them.
I've noticed some 8xx sections directly mention 60601.

Is that correct? I'd really like to know exactly what the linkage is. I would make an assumption that exactly what "version" of 60601-1 to follow depends a bit on company/marketing strategy as far as where the device will be sold, is that true? ?
Refer to Recognized Consensus Standards to see which standards (and versions) are acceptable with the FDA.
What is the difference if my device did not have its own "subcategory" 8xx section, what would I follow then? Is there a generic section which acts as a catch all?
If your device does not require special controls than general controls will suffice. See Regulatory Controls for a bit more information.

Or what if my device technically has a subcategory, but its under a main category that would not apply? For instance, there is an "Anesthesiology" upper category with 8xx subcategories that describe our device very well, however our device is not Anesthesiology related in any way. Would we still use those 8xx categories that seem to describe it?
This is a specific situation that requires specifics to reach a sound decision. In some case a consultation meeting with FDA may be necessary.

Good-luck with your transition to RA/QA.

Shimon
 
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