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
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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