Are Medical Device Servicing Instructions Part of Labeling?

Aphel

Involved In Discussions
#1
Hello!

Can you give some advice regarding the following topic:

Does a servicing instruction of a medical device belong to labeling?
Our auditor says yes...

I just want to know where in the US law is this defined?
I really would like to this special section...

Thank you very much for your support.
Best regards,
Aphel
 
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Marc

Hunkered Down for the Duration
Staff member
Admin
#2
My bet is no. Sorry, I'm not a medical device person but I'll try to help.

What clause, and in what standard, did the auditor cite?
 

yodon

Staff member
Super Moderator
#3
Look in the labeling guidance: http://www.fda.gov/downloads/Medica...onandGuidance/GuidanceDocuments/UCM095308.pdf

On p. 18 ('physical' p. 26), there's the statement: "Labeling includes ... maintenance manuals, etc." Might be splitting hairs between "service" and "maintenance" but that may be where they're coming from.

Irrespective of the "label" you give the service instructions, maybe the root of the issue raised is control? How do you control the service instructions (versus how would you control them if you considered them labeling)?

And clearly there are requirements for capturing service records so if the service instructions themselves are uncontrolled, the service records may be incomplete, inconsistent, etc. But maybe I'm overreaching.
 

Ronen E

Problem Solver
Staff member
Moderator
#4
I'd say definitely yes.

Service instructions would be an integral part of the intended use basis. They'd establish part of the "normal use" of the device, i.e. under what terms the device is intended to perform as labeled.

Cheers,
Ronen.
 

somashekar

Staff member
Super Moderator
#6
Put a symbol on the label which will mean to refer to user manual and within the user manual, have the servicing instructions clearly said in the contents...
 

Chris Ford

Quite Involved in Discussions
#7
<snip> Does a servicing instruction of a medical device belong to labeling?
Our auditor says yes... <snip>
Did you read the definitions and regulatory requirements for labeling?

I'm going to have to assume that since your auditor claimed the service instruction is labeling, that the service instruction accompanies the device and this servicing is performed by the customer.

If the service instruction is an internal document (ie an internal work instruction), then your auditor is obviously incorrect. If this instruction does accompany the device then it is labeling.

Section 201(m) defines 'labeling' as:

'all labels and other written, printed, or graphic matter
(1) upon any article or any of its containers or wrappers, or
(2) accompanying such article' at any time while a device is held for sale after shipment or delivery for shipment in interstate commerce.

FDA has also explained what it means by "accompanying" just to be sure there's no confusion...

The term 'accompanying' is interpreted liberally to mean more than physical association with the product. It extends to posters, tags, pamphlets, circulars, booklets, brochures, instruction books, direction sheets, fillers, etc. 'Accompanying' also includes labeling that is brought together with the device after shipment or delivery for shipment in interstate commerce. Yes... this even extends to the internet. If you post a service instruction on a website, it's labeling. In fact, the entire website (relative to the medical device) is labeling, whether it's about servicing, performance claims, clinical claims, etc.

So, you see there is no wiggle room in the interpretation. If it's provided to the customer, it's Labeling.

The need for such labeling is determined by the device intended use and the safety and effectiveness of the device. If service instructions are necessary for the ongoing performance of the device (which means assuring that the device remains safe and effective), then these instructions must be included in the device labeling.

In determining the safety and effectiveness of a device for its intended use, the following factors are to be considered and addressed in the device's labeling by the inclusion of appropriate information:

  • The persons for whose use the device is represented or intended
  • The conditions of use for the device, including conditions of use prescribed, recommended or suggested in the labeling or advertising of the device, and other intended conditions of use;
  • The probable benefit to health from the use of the device weighed against any probable injury or illness from such use;
  • The reliability of the device; and,
  • Other relevant factors.

One of the easiest, quickest routes to a 483 and Warning Letter is a labeling error. A very simple error on your part can become a very costly mess, if FDA finds your device is misbranded or adulterated. A labeling field correction could cost the company tens of thousands of dollars, so if you don't have an experienced regulatory professional at the company, I'd highly recommend that you speak with a consultant about your device labeling. There are several nuances to consider with regard to the required labeling for specific devices and device types, and it's really not a topic to be taken lightly.
 

Ronen E

Problem Solver
Staff member
Moderator
#8
@Chris Ford:

Just so that people don't get confused:

One of the easiest, quickest routes to a 483 and Warning Letter...
A warning letter is indeed a result of an apparent failure on behalf of the regulated party; however, a completed 483 form (inspection findings) being issued could be just a routine outcome of normal FDA operation. Of course, if there are findings worth noting then it means the inspected party has a <100% compliant conduct (at least by the investigator), but this is very common and doesn't necessarily mean gross misconduct. Typically, USA-based entities get inspected on a regular basis, regardless of them being suspected by FDA for anything, and except in the uncommon case, there will be some findings. The 483 is just a wrap-up of such findings, which may in fact be quite minor (though non-negligible). Of course, if the recipient of a 483 doesn't handle it properly, it can lead to a warning letter. But that's a separate issue.

Other than that I mostly agree with your analysis.

Cheers,
Ronen.
 

Chris Ford

Quite Involved in Discussions
#9
@Chris Ford:

Just so that people don't get confused:

A warning letter is indeed a result of an apparent failure on behalf of the regulated party; however, a completed 483 form (inspection findings) being issued could be just a routine outcome of normal FDA operation. Of course, if there are findings worth noting then it means the inspected party has a <100% compliant conduct (at least by the investigator), but this is very common and doesn't necessarily mean gross misconduct. Typically, USA-based entities get inspected on a regular basis, regardless of them being suspected by FDA for anything, and except in the uncommon case, there will be some findings. The 483 is just a wrap-up of such findings, which may in fact be quite minor (though non-negligible). Of course, if the recipient of a 483 doesn't handle it properly, it can lead to a warning letter. But that's a separate issue.

Other than that I mostly agree with your analysis.
Other than the original post having nothing to do with the definition and use of Form 483, or how it can manifest in a Warning Letter, I can't disagree with your description. Still, labeling violations are highly cited on Form 483 and in Warning Letters. There is no debating that, or the fact that labeling violations can and often do result in very costly field corrections.

Regardless, my point is accurate and I certainly see no point in splitting hairs or mincing words about the definitions and use of the 483.

No determination can be made regarding the original question, without further understanding the device and the document that the original question refers to. The original post does not explain the auditor's rationale for determining that the service instruction is labeling, nor does the original post explain why it is not labeling.

So to be perfectly accurate in answering the original question, and based on the information provided, there is no answer. Service instructions may or may not be labeling. However, I thought it would be more useful to point to the labeling regulation and the definition of labeling rather than give the OP a canned yes or no. Always err on the side of caution, until all of the information can be considered.
 

Ronen E

Problem Solver
Staff member
Moderator
#10
Other than the original post having nothing to do with the definition and use of Form 483, or how it can manifest in a Warning Letter, I can't disagree with your description. Still, labeling violations are highly cited on Form 483 and in Warning Letters. There is no debating that, or the fact that labeling violations can and often do result in very costly field corrections.

Regardless, my point is accurate and I certainly see no point in splitting hairs or mincing words about the definitions and use of the 483.

No determination can be made regarding the original question, without further understanding the device and the document that the original question refers to. The original post does not explain the auditor's rationale for determining that the service instruction is labeling, nor does the original post explain why it is not labeling.

So to be perfectly accurate in answering the original question, and based on the information provided, there is no answer. Service instructions may or may not be labeling. However, I thought it would be more useful to point to the labeling regulation and the definition of labeling rather than give the OP a canned yes or no. Always err on the side of caution, until all of the information can be considered.
It's all good, I feel we're not actually saying much different.

Now, I didn't bring the 483s into this thread - you did. And relating to that, I didn't argue that you were not acurate. In fact, I don't feel I negated your post; I only added upon it. You may be very knowledgeable in that regard, but please remenber that many of this forum's visitors do not possess the relevant expertise, or may not master all the relevant nuances. So as a regular here, I feel that it's appropriate - every once in a while - to try and simplify / disambiguate things wherever there's a fair chance that a newbie or the occasional visitor might misinterpret. There's no obligation on anyone to do that - I do it because I like helping people, and the feedback I got so far from Cove users is that this is welcome and appreciated. I'm not preaching to anyone, though. I also trust that if that was disruptive to discussions, I would have heard about it from the moderators by now (and I haven't).

I guess what I was trying to state in the previous post was - in short - that most USA-based, FDA regulated entities will get a 483 sooner or later, either with or without having major labelling (or other) compliance issues. It's mostly a natural, normal outcome of the system, and doesn't say that all these entities are in severe misconduct. To clarify: I don't claim you wrote or intended to say otherwise. Once again, I mostly agree with the views you expressed.

Peace,
Ronen.
 
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