FDA UDI markings "label" vs. "labelling" (labeling)?

G

Gaby

Hello,

The typical packaging structure of our devices (sold at OTC retail pharmacies) is:
-> device itself (with permanently affixed data plate ... info is affixed either via direct print/silk-screen or via permanent sticker)
--> poly-bags, liners, manual, quick start guides, etc
---> retail box​
---> inner carton​
----> master carton​

Per 21 CFR Part 801.3
Device package means a package that contains a fixed quantity of a particular version or model of a device.
Label has the meaning set forth in section 201(k) of the Federal Food, Drug, and Cosmetic Act.

Per section 201(k) of the Federal Food, Drug, and Cosmetic Act:​
(k) The term “label” means a display of written, printed, or graphic matter upon the immediate container of any article; and a requirement made by or under authority of this chapter that any word, statement, or other information appear on the label shall not be considered to be complied with unless such word, statement, or other information also appears on the outside container or wrapper, if any there be, of the retail package of such article, or is easily legible through the outside container or wrapper.​
(l) The term “immediate container” does not include package liners.​
(m) The term “labeling” means 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.​

When it comes to UDI marks, FDA's requirements are that (21CFR801.20(a))–
(1) The label of every medical device shall bear a unique device identifier (UDI) ....
(2) Every device package shall bear a UDI ....

Would you be of the opinion that the data plate falls under the term “label” thus requiring to include a UDI?

Our reading of all above definitions has led us to come down to the following:
1) The “immediate container” of our articles is really the retail box because we do not use any other containers “immediately” containing our devices. Thus, in our case the "immediate container" is the same as the "outside container" = retail box.
2) The data plate permanently affixed to our devices falls under “other written, printed, or graphic matter (1) upon" the article ("labeling") and does NOT require to include a UDI.

Thoughts from members of this forum are highly appreciated.
 

somashekar

Leader
Admin
1) Immediate container is the retail box, I tend to agree.
2) UDI serves many purposes both before device use, during device use, as well as upon disposal. Hence UDI is required on the data plate.
 
G

Gaby

1) Immediate container is the retail box, I tend to agree.
2) UDI serves many purposes both before device use, during device use, as well as upon disposal. Hence UDI is required on the data plate.

@somashekar thanks for your feedback.
We do apply UDI marks on the retail box (in our interpretation - the device "label") as well as inners and masters (in our interpretation - "device packages"). If the data plate is rather "labeling" then UDI should not be required but rather voluntary? Tks.
 
G

Gaby


@Gaby
, have you looked at 801.45?

@Ronen E - yes, I have. While our devices are intended to be used more than once they are NOT intended to be reprocessed before each use.
Thus, UDI direct marks (which to me is what we would be doing by including UDI in data plates) should be n/a.

Thoughts?
 
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