Class II Accessory Labeling Conundrum

#1
I have a unique situation and can't find a specific answer.

I have a Class II reusable accessory and the labeling requirements per FDA have me stumped.

The device is a mounting bracket that allows hospitals to mount the capital unit to a wall in the OR. Nonsterile, not re-processable. It's literally a piece of metal and some screws. It is sold separately and on its own.

Labeling is currently:
Outer Carton with label
Inner poly bag that contains parts with no label on the bag.

Are we out of compliance by not having a label on the inner poly bag? Do such products require direct marking?

Any thoughts are appreciated as I am at a loss here.
 
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#4
Looks like the regulation does not have specific requirements for when direct marking is applicable. Interesting. These are minimum requirements though.
ISO 20417 is a consensus standard: Recognized Consensus Standards

It says the following:

c) The information required in 6.1 shall be provided as a marking unless:
1) the size of the medical device or accessory does not allow fixation of this information on the medical device or accessory;
2) the nature of the outer surfaces does not allow fixation of this information on the medical device or accessory; or
3) the omission of these markings does not adversely affect the benefit/risk balance according to ISO 14971:2019.
 

Ronen E

Problem Solver
Moderator
#6
Looks like the regulation does not have specific requirements for when direct marking is applicable. Interesting. These are minimum requirements though.
ISO 20417 is a consensus standard: Recognized Consensus Standards

It says the following:

c) The information required in 6.1 shall be provided as a marking unless:
1) the size of the medical device or accessory does not allow fixation of this information on the medical device or accessory;
2) the nature of the outer surfaces does not allow fixation of this information on the medical device or accessory; or
3) the omission of these markings does not adversely affect the benefit/risk balance according to ISO 14971:2019.
Labeling questions become relevant only once classification is established. Pay very close attention to classification before you proceed.
Recognized consensus standards don't have a blanket mandatory applicability. They are mandatory only if they are noted as Special Controls under the relevant procode.
 
Last edited:
#7
Labeling questions become relevant only once classification is established. Pay very close attention to classification before you proceed.
Recognized consensus standard don't have a blanket mandatory applicability. They are mandatory only if they are noted as Special Controls under the relevant procode.
I guess I assumed that classification was already established since the OP stated the accessory is Class II.

Also, please help to clarify. Are there any Class II devices exempt from GMP and labeling requirements? I would think that all consensus standards categorized as specialty task group area General I (QS/RM) should be followed for Class II devices. What am I missing here?
 

Ronen E

Problem Solver
Moderator
#8
I guess I assumed that classification was already established since the OP stated the accessory is Class II.
"The device is a mounting bracket"
"It's literally a piece of metal and some screws"
These are warning signs, and regardless it's always healthy to doubt the initial classification where details are scarce.

Are there any Class II devices exempt from GMP and labeling requirements?
No.
The applicability question stemmed from me not being sure that it's actually a medical device / accessory (not from the class). in the USA classification is established by identifying a correct regulation/procode, and once that's done the class is a given. So the confirmation that it's a medical device / accessory and the class determination happen technically at the same moment.

I would think that all consensus standards categorized as specialty task group area General I (QS/RM) should be followed for Class II devices.
Source?
 
#9
Ah yes, perhaps I should have been more skeptical. Regarding complying with the standard, no source. That is why I said "should." Compliance to standards is voluntary of course.
 

Ed Panek

QA RA Small Med Dev Company
Leader
Super Moderator
#10
You claim it's reusable but the next sentence is not reprocessable. I'm confused by that.

As a medical device, what is/are its claim(s)?

Generally, FDA requires labeling on the "final user packaging" or its point of use. For example, the bottle and not the box of aspirin has all details. Users of aspirin don't store it in the box but they do store it in the bottle.

Is the device intended to be opened prior to use in packaging without labeling? Thats an issue.
 
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