UDI Registration - Class II Medical Device Software

#1
Hi everyone,

My company makes Class II medical device softwares. I was wondering if we have to register our pre-existing Class II softwares in GUDID? We currently do not have our class II medical device softwares listed in the GUDID account. It is my understanding that devices manufactured and labeled prior to compliance date is exempt from the UDI requirement up to 3 years.


Following excerpt is taken from Unique Device Identifier System: Frequently Asked Questions, Vol. 1 issued on August 20,2014.

A.11. Question: Are devices manufactured and labeled prior to the compliance date subject to UDI requirements?

UDI requirements apply to devices placed into commercial distribution after the compliance date that applies to the device. A finished device manufactured and labeled prior to its compliance date and held in inventory is excepted from UDI requirements for three years after the compliance date. This exception applies to both products held in inventory by the labeler and those consigned to a hospital or other potential purchaser and held in inventory, but not yet purchased, by the potential purchaser. This exception applies to all UDI requirements.


Our plan is to register our softwares for upcoming software update that will include UDI in user manual, "about" dialog in the software, etc. But since our GUDID account does not currently list our class II softwares, are we being non-compliant to 21 CFR 830 UDI?

Any input are greatly appreciated. Thanks!
 
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QA-Man

Involved In Discussions
#2
Very interesting question! Assuming the software is stand-alone, the question you're really with is "what is the manufacturing date"?

If the software is distributed in a packaged form, I would assume the manufacturing date is the date an individual unit is released for sale.

If the software is not packaged (downloaded from Internet), I would assume the manufacturing date was the last time a change was approved and the revised product was available.

Regardless, I would base my decision on the manufacturing date in the DHR; it is a record you must have and it must include a manufacturing date.
 
D

Deepthi36

#3
Hi there,

Existing Class II devices are NOT EXEMPT from the UDI requirement.

The exception only applies to LABELING of Class II devices that were labeled before the compliance date. In such case, i.e. inventory that was not labeled prior to the compliance date, you don't have to go and rework all the parts to have UDI-compliant labels.

Similarly any Class II product that is already in the field does not need to be retrofitted with UDI-compliant labels.

However you are expected to do everything else - i.e. create a UDI, register with the GUDID etc. for all Class II (and Class III devices).

Hope this helps. Let me know if you have any further questions.
Deepthi
 

QA-Man

Involved In Discussions
#4
However you are expected to do everything else - i.e. create a UDI, register with the GUDID etc. for all Class II (and Class III devices).
That's not true.

If he doesn't have a product required to bear a UDI then he doesn't have to submit data to the GUDID database. That means if everything was manufactured before September 24th and then nothing since, no GUDID entry is required because no products are required to bear a UDI. See 21CFR830.300(a).
 
#5
Hi there,

Existing Class II devices are NOT EXEMPT from the UDI requirement.

The exception only applies to LABELING of Class II devices that were labeled before the compliance date. In such case, i.e. inventory that was not labeled prior to the compliance date, you don't have to go and rework all the parts to have UDI-compliant labels.

Similarly any Class II product that is already in the field does not need to be retrofitted with UDI-compliant labels.

However you are expected to do everything else - i.e. create a UDI, register with the GUDID etc. for all Class II (and Class III devices).

Hope this helps. Let me know if you have any further questions.
Deepthi
Perhaps you are thinking of this in terms of physical items. I feel that for software, the manufacture date is the date of the software release (except when you produce it in packaged form). When people download the software from the website, the software is not being manufactured and given to the customer.

Also, I do not see the point in registering the UDI for a device that does have UDI in the labeling. Let's say FDA wants to recall Product X. Announcement was made that Product X with UDI:xxxxxxxxxx should be returned to the manufacturer. UDI does not help identify the device at fault because device it self or labeling do not have UDI.
 
D

Deepthi36

#6
That's not true.

If he doesn't have a product required to bear a UDI then he doesn't have to submit data to the GUDID database. That means if everything was manufactured before September 24th and then nothing since, no GUDID entry is required because no products are required to bear a UDI. See 21CFR830.300(a).
Hi there,

You seem to be confused between two different things here:
1.) UDI Compliance to the Regulation 21CFR Part 830
2.) UDI in Labeling, 21 CFR 801 Subpart B

The exception you are citing is to 21CFR801 Subpart B, i.e. "Do I need to put UDI barcodes on labels for all product that I have sitting in the field and in inventory that were labeled prior to the compliance date?"

So yes, you are excepted from putting the UDI in the Label. However you are absolutely required to apply UDI to all products that are currently in distribution. Therefore, you are required to assign a UDI, publishing the data in the GUDID etc. I have worked at 2 giant medical device companies since the UDI rule came into effect and at both places - all devices in current distribution were made to comply with the UDI rule - regardless of when the they first entered the market.

However we did use the inventory exception (in 21 CFR 801 Subpart B) to justify not reworking all our labels of products in inventory.

TLDR: All Class II and Class III device must at this point have assigned UDIs and comply with all the steps of the UDI regulation including registration in the GUDID. The UDI is meaningless without the GUDID registration piece. You may use the inventory exception in 801 Part B for parts labeled prior to the UDI compliance date.

Hope this helps.
 
Last edited by a moderator:
D

Deepthi36

#7
Perhaps you are thinking of this in terms of physical items. I feel that for software, the manufacture date is the date of the software release (except when you produce it in packaged form). When people download the software from the website, the software is not being manufactured and given to the customer.

Also, I do not see the point in registering the UDI for a device that does have UDI in the labeling. Let's say FDA wants to recall Product X. Announcement was made that Product X with UDI:xxxxxxxxxx should be returned to the manufacturer. UDI does not help identify the device at fault because device it self or labeling do not have UDI.
Peter,

Agreed with you on the manufacturing date of a particular software version. If you are selling software that is imaged at one point and every sale of that software is the exact same image - then the manufacturing date is the date of approval and release of that software image. Therefore, let's say you created an image of your Class II software before Sept 24, 2016, then you can use the inventory exception rule to not have the UDI in the about screen - until the next release that needs a UDI. Then, you have to put the UDI in the About Screen.

Your second point --> Just because the UDI is not in the label (for 3 years max by the way), doesn't mean that it cannot be traced. By entering your data into the GUDID, you are providing FDA with information such as Pro Code, GMDN, and tons of other information that is useful in case of a recall. So, let's say you don't have the UDI in your About Screen. Customer calls you and says "Hi, I have an adverse event related to your product... Software X, Version 1.1" --> you will enter this product name, version and UDI which your service team will have on file, in the Service Record, Complaint File and the MDR and you may initiate a recall. --> FDA can take your UDI and use the GUDID attributes to identify all similar devices that are affected (by using the GMDN Code, or Pro Code for example). This is one of the MANY ways in which UDI is useful even if it is not on the label, for now. It is meant to become a holistic, big-data approach to recalls and is the real push for the UDI regulation by the FDA.

Finally, reading the UDI FAQ response, it says "UDI requirements apply to devices placed into commercial distribution after the compliance
date that applies to the device. " The key phrase -- placed into commercial distribution. Are you planning to sell more of your software after Sep 24 2016? If yes, you are "placing" the device being sold "into commercial distribution" after the deadline and therefore this exception does not apply.

Not complying with the UDI requirement is a serious non-compliance and I suggest contacting the UDI Help Desk directly for advice.

All the best!
 
Last edited by a moderator:

yodon

Staff member
Super Moderator
#8
Then, you have to put the UDI in the About Screen.
Very interesting discussion, thanks to all who contributed. This may be a silly line of questions but would the UDI label in the about screen be the standard barcode plus other information? Would that even be readable (with a barcode reader - I know the scanners at, say, the airport can read barcodes off mobile devices but I'm not sure about all readers and monitors)? Further, if the software was intended to run (also) on a mobile device, I guess there would be an expectation that it renders properly on the device?
 

Ronen E

Problem Solver
Staff member
Moderator
#9
Very interesting discussion, thanks to all who contributed. This may be a silly line of questions but would the UDI label in the about screen be the standard barcode plus other information? Would that even be readable (with a barcode reader - I know the scanners at, say, the airport can read barcodes off mobile devices but I'm not sure about all readers and monitors)? Further, if the software was intended to run (also) on a mobile device, I guess there would be an expectation that it renders properly on the device?
The UDI requirement for software doesn't require a barcode (or 2D code) in the software screens. It requires the UDI to appear in human readable format at software startup or in an "about-type" menu item.
 
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