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


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nz1nz2, just follow the requirements for the "unclassified" status. Forget about 510(k), it has nothing to do with this.
The only problem is that there is no refernce for Unclassified devices. :-(

For example according to 21 CFR 801.40(d)) states that a Class I device that bears a U.P.C. on its label and device packages is deemed to meet all UDI labeling requirements and that the U.P.C. will serve as the UDI required by §801.20. but i don't find any specific requierments for unclassified devices


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21 CFR 801.20 a (2) states that "Every device package shall bear a UDI that meets the requirements of this subpart and part 830 of this chapter."

801.30 provides exemptions and 801.40 provides additional specific cases. These don't apply to you unless 'unclassified' device type is mentioned.
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.

I'm sorry if I was not clear. We are discussing two things here:
1. The date in which the OP must comply with UDI requirements, and
2. The specific UDI requirements from 21CFR801 that are applicable to the medical device.

For item 1.: The date for compliance is according to the "Compliance Dates for UDI Requirements."
For item 2: The UDI requirements for the medical device are all those that apply to Class II/III devices. (In other words, the CFR lists requirements for Class I devices. The artificial saliva device is not a class I device; therefore, Class I requirements do not apply.)
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.

Sorry if I caused confusion. All I am saying is that your device is not a Class I.


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I would like to thank everyone who participated in the discussion. It's a very good and professional forum . I'm glad i've joined
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