SBS - The best value in QMS software

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

nz1nz2

Starting to get Involved
#1
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.
 
Elsmar Forum Sponsor
#2
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.
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).
 
Thread starter Similar threads Forum Replies Date
G FDA UDI markings "label" vs. "labelling" (labeling)? US Food and Drug Administration (FDA) 4
K Two FDA questions regarding UDI (and potentially 803.52 MDR) Other US Medical Device Regulations 0
L UDI Requirments Gap Analysis - EU MDR vs FDA CFR EU Medical Device Regulations 8
M Informational US FDA issued the first warning letter for UDI violations to help ensure compliance Medical Device and FDA Regulations and Standards News 0
J FDA Class 1 Medical Device UDI requirements Other US Medical Device Regulations 19
M Medical Device News FDA Guidance - UDI: Policy Regarding Compliance Dates for Class I and Unclassified Devices and Certain Devices Requiring Direct Marking Other US Medical Device Regulations 0
N Will an FDA UDI be compatible with a European MDR UDI? EU Medical Device Regulations 7
D FDA UDI Class I Compliance Date Extended US Food and Drug Administration (FDA) 1
M FDA UDI with Multiple Packaging Configurations Other US Medical Device Regulations 3
Pmarszal FDA Global UDI Database: Record Submission Retention Other US Medical Device Regulations 1
Q US FDA UDI Compliance Question - Class II (Special Controls) Other Medical Device and Orthopedic Related Topics 4
Ronen E FDA issues draft guidance on form & content of UDI Other US Medical Device Regulations 0
bio_subbu FDA issues Guidance on UDI - Frequently Asked Questions, Vol. 1 Other US Medical Device Regulations 1
bio_subbu FDA issues Small Entity Compliance Guidance for UDI Other US Medical Device Regulations 1
K UDI (Unique Device Identification) requirements of US FDA US Food and Drug Administration (FDA) 4
L New Website from the FDA concerning UDI Exceptions, Alternatives and Time Extensions Other US Medical Device Regulations 0
Ajit Basrur ICCBBA Is Now an FDA-Accredited Issuing Agency for Unique Device Identifiers (UDI) Other US Medical Device Regulations 1
Sam Lazzara 12 Steps to FDA UDI (Unique Device Identification) Compliance (2013 - 2015) Other US Medical Device Regulations 45
X FDA UDI (Unique Identification) amendment on 19 Nov 2012 - Date of 'final rule'? US Food and Drug Administration (FDA) 4
K Are you wondering about FDA's UDI rule? Here's a non-exhaustive summary: Other US Medical Device Regulations 12
S US FDA Unique Device Identification (UDI) Proposed Rule 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 18
J FDA regulation on decorative contact lenses Medical Device and FDA Regulations and Standards News 4
P Anyone have an Idea on UAE Medical device registeration- Class B with FDA only Other Medical Device Regulations World-Wide 0
F FDA classification for a mobile app Medical Information Technology, Medical Software and Health Informatics 2
Ed Panek IFU Contact Requirements - FDA and MDD/MDR US Food and Drug Administration (FDA) 1
O Any info on release date of FDA “Computer Software Assurance for Manufacturing and Quality System Software” document? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 0
P Writing a presubmission to the FDA prior to the De novo submission US Food and Drug Administration (FDA) 4
K FDA - Can we have more than 1 Initial Importer Medical Device and FDA Regulations and Standards News 4
R Importers - For the FDA Registration/ Listing, is the CMO the importer? Medical Device and FDA Regulations and Standards News 6
Z Iterative development and FDA change requests IEC 62304 - Medical Device Software Life Cycle Processes 12
P FDA Approved Product Contact Parts ISO 13485:2016 - Medical Device Quality Management Systems 6
O Clarifying FDA definition of "finished device" and “capable of functioning” 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
A FDA guidance on non-sterile Medical Device Packaging Medical Device and FDA Regulations and Standards News 6
JoCam FDA Registration for Sub-contract manufacturers Medical Device and FDA Regulations and Standards News 2
M FDA News FDA Releases Draft Guidance Clarifying Application of ISO 10993-1 Biocompatibility Standard Medical Device and FDA Regulations and Standards News 0
M Is IEC 60601-1-2 required by FDA for all electronic medical devices? IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
E Contract manufacturer FDA requirements foreign company US Food and Drug Administration (FDA) 6
P Choice of FDA reviewer US Food and Drug Administration (FDA) 6
J Is Device Tracking Card an actual requirement under FDA regulation? Other US Medical Device Regulations 0
T Definition Human Use (FDA) Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 7
K FDA 510k electrosurgery 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 0
J Leveraging FDA 510k Clearance for International Registrations Other Medical Device Regulations World-Wide 2
shimonv FDA News FDA guidance on Multiple Function Device Products (8/2020) Other US Medical Device Regulations 1
J FDA notification of address change US Food and Drug Administration (FDA) 2
N Usability testing required for FDA IDE (investigational device exemption)? Human Factors and Ergonomics in Engineering 3
A FDA Class Classification for a cabinet 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
L FDA Biocompatibility Requirements - Transitory Contact Other US Medical Device Regulations 1
Edward Reesor FDA DM and /or Class I Life Saving US Food and Drug Administration (FDA) 0
Watchcat FDA will not tolerate fraud…meaning what, exactly? Other US Medical Device Regulations 6
K FDA Premarket Cybersecurity Guidance - 4 questions Other US Medical Device Regulations 5

Similar threads

Top Bottom