What is our product classification? (Does Unclassified classification still exists)

nz1nz2

Starting to get Involved
#1
Dear members,
I've started working on implementing UDI for a Artificial saliva medical device Called Caphosol which recieved 510(k) www.accessdata.fda.gov/scripts/cdrh/devicesatfda/index.cfm?db=pmn&id=K991938 back in 1999 and also in 2013 (indication extension) www.accessdata.fda.gov/scripts/cdrh/devicesatfda/index.cfm?db=pmn&id=K030802
. As far as I understood it is classified as unclassified (Pre-Amendment ) - Product Code LFD
www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?id=1421

However, when asking our US agent confirmation he said it is class II. I've asked for his explaination and i'm quoting it here below since i didn't understand it and reading the FDA explanation didn't help me. Does Unclassified classification no longer exists (UDI refers to it so doenst sound logical to me)? and if yes, how should i classify my product?

[Start quote]
Yes - how the US FDA handles an "unclassified" device and listing is very confusing. Here is some history:
The Product Code is the place to start see
www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?id=1421

Please note the "unclassified reason" as "Pre-Amendment." What this means is that Artificial Saliva was released by the FDA before 1976. Beginning in 1976 the US Government mandated the FDA to stop using drug classifications for medial devices and write and release device classifications. Part of ‘new’ device classifying process was ‘Product Codes’ however, the FDA never use ‘Product Codes’ to control anything until the late 1990s. Then it somehow became very important - never understood that. To add to the confusion the total classification of a medical may be in 21CFR Part XXX.XXXX, Product Code, and Safety status, i.e., Class I, II, or III. These are just the opposites of the EU system listing in meaning. The FDA has never produced classifications for devices that they only see one or two 510(k)s in twenty years or so. With artificial saliva they (FDA), - may never write a classification requirement, thus, allowing the confusion to go on for ever.

With your device/product the confusion began with ‘Unclassified’ 510(k), and Class I. Now all Class I devices are 510(k) exempt. However, your device has some risk, thus, requires a 510(k) submission to receive FDA release to market. At present all devices that require a 510(k) submissions are in Class II. All Class II devices require a UDI code in the labeling. You have one FDA document that would allow an argument that a UDI is not required until Sep, 2020. After that date you will have to have a UDI code on the labeling. In short, the door will close in Sep 2020 for Unclassified devices, whatever they are. Is any of this any help?
[End of Quote]

Thank you in advance
 
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nz1nz2

Starting to get Involved
#2
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mihzago

Trusted Information Resource
#3
Unclassified status does still exist; there are many product codes (over 100) with this status (there's also a type called "not classified" to add to the confusion; over 300 devices).
Classification however is not tied to the submission type, as your US agent seems to imply; nor are all class I devices exempt from 510(k). There are many Class I devices that require a 510(k), and there are many class II devices that are exempt from 510(k).

In your case, it appears that you have a device type with a product code that has no class status assigned but it requires a 510(k) as a premarket notification, which is why your US agent probably thinks it's a Class II device. Since you still have to comply with all General Controls in addition to the 510(k), it's almost as if you had a Class II device.
 

nz1nz2

Starting to get Involved
#4
Unclassified status does still exist; there are many product codes (over 100) with this status (there's also a type called "not classified" to add to the confusion; over 300 devices).
Classification however is not tied to the submission type, as your US agent seems to imply; nor are all class I devices exempt from 510(k). There are many Class I devices that require a 510(k), and there are many class II devices that are exempt from 510(k).

In your case, it appears that you have a device type with a product code that has no class status assigned but it requires a 510(k) as a premarket notification, which is why your US agent probably thinks it's a Class II device. Since you still have to comply with all General Controls in addition to the 510(k), it's almost as if you had a Class II device.
Thank you for taking the time to answer. Much appriciated.
However i still don't understand why our agent refers to the submission type as the product recieved 510(K) in 1999?
And in a more practial approach, with regarding to UDI is it OK that i will follow the "unclassified" requierements?
 

indubioush

Quite Involved in Discussions
#5
I think what the agent is saying is that you have until Sep 2020 to implement the UDI because your device is unclassified, but when implementing the UDI, you will need to follow the UDI requirements that would apply to a Class II device.
 

nz1nz2

Starting to get Involved
#6
I think what the agent is saying is that you have until Sep 2020 to implement the UDI because your device is unclassified, but when implementing the UDI, you will need to follow the UDI requirements that would apply to a Class II device.
Yes. This sounds in-line with what he wrote but how does this makes sense? Why Class II and not Class I ? just because class I are currently exempted from 510(K) registration?

I found this guidence onlline Medical Device Classification Product Codes https://www.fda.gov/media/82781/download (2013) indicating that

2. Premarket Notification [510(k)] Devices
A. Classification – Product codes are assigned within established classification regulations as described in 21 CFR Part 860. They are also assigned to unclassified devices and not-classified devices. An unclassified device is a pre-amendments device for which a classification regulation has not been promulgated. Until the unclassified device type has been formally classified and a regulation established, marketing of new devices within this type will require submission of a 510(k) premarket notification to CDRH or CBER. Once classified, these devices may require submission of a PMA, a 510(k), or be exempt from any premarket submission. ....

which means the need for 510(k) results from being unclassified.
 

Ajit Basrur

Staff member
Admin
#7
Thank you for taking the time to answer. Much appriciated.
However i still don't understand why our agent refers to the submission type as the product recieved 510(K) in 1999?
And in a more practial approach, with regarding to UDI is it OK that i will follow the "unclassified" requierements?
Per the Product Classification, the device (product code LFD is "Unclassified" but requires a 510(K) submission (see screenshot attached) and for this reason, the products referenced in your first post required a 510(K) submission that were subsequently approved by the Agency.

There are certain "Unclassified" devices exempted from Premarket Notification requirements and the product code LFD is not in that list. See https://www.fda.gov/media/89238/download. This means that a 510(K) submission is definitely required for your product.

Do not worry on the device classification as either Class I or Class II - these are not and hence "Unclassified" - treat this as a Class in itself.
 

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indubioush

Quite Involved in Discussions
#8
Your device is considered unclassified because its predicate was on the market prior to 1976.
However, when it comes to unique device identification, some determination has to be made whether your device falls under requirements for Class I or for Class II/III.
Your device has some risk, so it cannot fall under Class I when considering UDI.
Therefore, you should follow requirements for UDI that apply to non-Class I products.
 

mihzago

Trusted Information Resource
#9
Your device is considered unclassified because its predicate was on the market prior to 1976.
However, when it comes to unique device identification, some determination has to be made whether your device falls under requirements for Class I or for Class II/III.
Your device has some risk, so it cannot fall under Class I when considering UDI.
Therefore, you should follow requirements for UDI that apply to non-Class I products.
I don't think that's correct. This FDA page Compliance Dates for UDI Requirements clearly distinguishes 'unclassified' from other devices classes, and describes enforcement discretion for various elements of UDI based on the status. Submission type based on the risk has nothing to do with UDI requirements.

nz1nz2, just follow the requirements for the "unclassified" status. Forget about 510(k), it has nothing to do with this.
 

nz1nz2

Starting to get Involved
#10
Your device has some risk, so it cannot fall under Class I when considering UDI.
Are you refering to our agent email when saying our device has some risk or from some other reason?
The product is a mouthwash of some salts which althought used to treat mouth dryness (also after radiation) is spitted after 30 seconds. It was classified many years as Class I device in EU and now might be classified as class II due to the MDR regulation. Our company consider it as low risk product.
Thank you again for your knowledgeable responses.
 
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