FDA UDI - Label vs. Labeling - Does the insert need to include UDI?

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nz1nz2

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I would like to confirm our consultant comment that the insert (patient leaflet,IFU) also [in addition to the outer carton] need to include the UDI information and if so, can it only include the DI (UDI code) or also the PI part (LOT/EXP) info which means we will need to create new insert for each new batch/lot production.

Sec. 830.3 Definitions.
... Label has the meaning set forth in section 201(k) of the Federal Food, Drug, and Cosmetic Act.

Label vs. Labeling
Device Labeling
Section 201(k) defines 'label' as a:
  • 'display of written, printed, or graphic matter upon the immediate container of any article...'
    The term 'immediate container' does not include package liners. Any word, statement, or other information appearing on the immediate container must also appear 'on the outside container or wrapper, if any there be, or the retail package of such article, or is easily legible through the outside container of wrapper.'
    Section 201(m) defines 'labeling' as:
  • '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' at any time while a device is held for sale after shipment or delivery for shipment in interstate commerce.
    The term 'accompanying' is interpreted liberally to mean more than physical association with the product. It extends to posters, tags, pamphlets, circulars, booklets, brochures, instruction books, direction sheets, fillers, etc. 'Accompanying' also includes labeling that is brought together with the device after shipment or delivery for shipment in interstate commerce.
 
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nz1nz2 said:
I would like to confirm our consultant comment that the insert (patient leaflet,IFU) also [in addition to the outer carton] need to include the UDI information and if so, can it only include the DI (UDI code) or also the PI part (LOT/EXP) info which means we will need to create new insert for each new batch/lot production.

Sec. 830.3 Definitions.
... Label has the meaning set forth in section 201(k) of the Federal Food, Drug, and Cosmetic Act.

Label vs. Labeling
Device Labeling
Section 201(k) defines 'label' as a:
  • 'display of written, printed, or graphic matter upon the immediate container of any article...'
    The term 'immediate container' does not include package liners. Any word, statement, or other information appearing on the immediate container must also appear 'on the outside container or wrapper, if any there be, or the retail package of such article, or is easily legible through the outside container of wrapper.'
    Section 201(m) defines 'labeling' as:
  • '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' at any time while a device is held for sale after shipment or delivery for shipment in interstate commerce.
    The term 'accompanying' is interpreted liberally to mean more than physical association with the product. It extends to posters, tags, pamphlets, circulars, booklets, brochures, instruction books, direction sheets, fillers, etc. 'Accompanying' also includes labeling that is brought together with the device after shipment or delivery for shipment in interstate commerce.
Click to expand...
Hi, I just ran across this and see that you received no comments. There is no need to put your UDI in the IFU. What rule is your consultant citing? There is extensive guidance available at the main FDA web page slash UDI (I don't have enough posts to put a link).
 
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