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

G
#1
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.
 
Elsmar Forum Sponsor

somashekar

Staff member
Super Moderator
#2
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
#4
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
#5

@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?
 
Thread starter Similar threads Forum Replies Date
M Supplier requirements - Major supplier is a Non-Profit registered with ICCBBA (FDA UDI) Supply Chain Security Management Systems 12
K Two FDA questions regarding UDI (and potentially 803.52 MDR) Other US Medical Device Regulations 0
N FDA UDI - Label vs. Labeling - Does the insert need to include UDI? Other US Medical Device Regulations 1
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
D FDA Guidance on Computer Software Assurance versus 21 CFR Part 11 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
G Does FDA allows remote approvals of quality documentation. Is there any specific guidance on signing any quality records remotely? Document Control Systems, Procedures, Forms and Templates 1
B Does FDA Registration QSR need to cover non-medical devices for contract repackager? US Food and Drug Administration (FDA) 1
C Non-sterile reusable surgical instruments - FDA sterilization requirement Other Medical Device Related Standards 2
D FDA Information - Revising the Instructions for Use US Food and Drug Administration (FDA) 0
S Transitional Adolescent A and B - "CDRH PREMARKET REVIEW SUBMISSION COVER SHEET FORM FDA 3514" Medical Device and FDA Regulations and Standards News 1
B FDA requirement for CAPA Signoff ISO 13485:2016 - Medical Device Quality Management Systems 6
P MSDS for MVQ FDA White, Vinyl Methyl Silicone Rubber EU Medical Device Regulations 4
S Manufacturing Process FDA FOIA Medical Device and FDA Regulations and Standards News 3
S Manufacturing Process FDA FOIA US Food and Drug Administration (FDA) 4
S Mechanical Test Under FDA Freedom of Information Act Medical Device and FDA Regulations and Standards News 5
A Medical Device Contract Manufacturer - Does the CM need to register with FDA? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
C RA (Regulatory Assurance) Training (FDA) looking for resources Training - Internal, External, Online and Distance Learning 5
E FDA 513(g) Cover Letter US Food and Drug Administration (FDA) 5
S Records - Do's and don't' of record entries (FDA - 21 CFR 820) Records and Data - Quality, Legal and Other Evidence 13
B New Facility register with FDA Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 4
K 510k FDA review, will they accept Biocompatibility result generated using feasibility product lots? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 8
J FDA regulation on decorative contact lenses Medical Device and FDA Regulations and Standards News 5
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 3
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 13
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

Similar threads

Top Bottom