SBS - The Best Value in QMS software

Label change - 510(k)

#1
Our company already submited and get clearance (510k) in 2018 for class II product. Is the submitted label the final one? We would like to make our label with less text than this one submitted to FDA using a insert.
Can we remove some text previous on the label and transfert to an insert? Do we need to submit to FDA the new ''cleaned'' label and the new insert? Is this kind of change an amendement to our 510k or only a notification? We searched at the regulation/requirement and it was not clear how to proceed with this change.
 
Elsmar Forum Sponsor

monoj mon

Quite Involved in Discussions
#2
Is the submitted label the final one?
YES
We would like to make our label with less text than this one submitted to FDA using a insert
Please elaborate, what do you mean by "less text" on the label. What are the types of text you are planning to relocate!
Can we remove some text previous on the label and transfert to an insert?
Have you done Risk Analysis on that, whether it will affect safe and effective use of the device?
Do we need to submit to FDA the new ''cleaned'' label and the new insert? Is this kind of change an amendement to our 510k or only a notification?
It depends on case to case, have you done evaluation based on the flowchart A from this guidance!

Assuming, you are only planning to remove the 'Accompanying text' of the symbols used on the label then you don't need to submit any pre-market notification to the FDA. See the FAQ No. 12 here.
 
#3
Good morning monoj,
Thanks for your feedback.
We looked at the Annexe A, but the change we want to do is not part of the multiple choice.
Your question: Please elaborate, what do you mean by "less text" on the label. What are the types of text you are planning to relocate!
Our label is very condensed in term of too much text on it, and hard to read. We would like to transfert certain texts to an insert. No change in the content. We will keep the symbol on the label beacuse there are only two. Sections as Precautions and Warnings, Adverse Events and Handling and Disposal and Instruction for use we want to relocate to the insert.
Any way to do this? Thanks
 

monoj mon

Quite Involved in Discussions
#5
Sections as Precautions and Warnings, Adverse Events and Handling and Disposal and Instruction for use we want to relocate to the insert
I wouldn't have placed those on the label at the first place, rather I would use the IFU to include these sections :notangel:. Anyway, shorter way could be evaluate the changes based on that guidance, do some risk analysis, make sure that you reach into a "Documentation" conclusion and place a sentence on your label saying that those sections are now available in the accompanying insert. However, this is just my opinion and I don't have any such prior experience similar to your case. If you are still in doubt then I would recommend to talk to a consultant or talk to FDA directly. Good Luck.
 
Thread starter Similar threads Forum Replies Date
S Device name change and label color change EU requirement? Other Medical Device Regulations World-Wide 6
A Timeframe for Product Label Update after Company Name Change 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
S Packaging and Label Change Requirements - ISO 13485/FDA 21CFR820 ISO 13485:2016 - Medical Device Quality Management Systems 3
J Class IIa Medical Device - Can I over label to change an address? ISO 13485:2016 - Medical Device Quality Management Systems 3
N OTC (Over The Counter) Product FDA Label Change Requirements US Food and Drug Administration (FDA) 2
M Methods used to label the package EU Medical Device Regulations 4
A Intended Purpose on device label EU Medical Device Regulations 7
H Medical Device Label Acceptance Criteria Manufacturing and Related Processes 4
M Label Making & Printing Standards ISO / ASTM ISO 13485:2016 - Medical Device Quality Management Systems 5
A ISO/DIS 15223-1:2020 - Country of manufacture label (IEC 60417 No. 6049) - Which national law requires this symbol? Other Medical Device Related Standards 0
D Private Label Distribution - US Other US Medical Device Regulations 1
A IEC 62304 safety classification, External Controls and off-label use related risks IEC 62304 - Medical Device Software Life Cycle Processes 5
JoCam EU Authorised Representative - Label EU Medical Device Regulations 1
R Error Proofing Label process Manufacturing and Related Processes 4
N FDA UDI - Label vs. Labeling - Does the insert need to include UDI? Other US Medical Device Regulations 1
K Sterile barrier system symbols - Label redlines for a Class III device (Kit Box) EU Medical Device Regulations 0
S California Cleaning Product Right to Know Act - Product Label advice needed Miscellaneous Environmental Standards and EMS Related Discussions 1
N Authorised Representative details on product label? EU Medical Device Regulations 1
C Ambient temperature_how we claim storage condition in label? Other Medical Device Related Standards 2
C Where to place CE/label in Sterile IVD EU Medical Device Regulations 1
J On PFMEA for danger labels - Label always should be assigned severity 10 ? FMEA and Control Plans 3
M Off-Label Use - Clarification of FDA Policy US Food and Drug Administration (FDA) 1
L N95 Respirators - Can we label our masks as N95? Other US Medical Device Regulations 8
S FDA Requirements for Medical Device Label Reconciliation 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
R Plea for advice on transitioning between Notified Bodies (label updates) Medical Device and FDA Regulations and Standards News 1
N Label Placement Requirement in MDD/MDR EU Medical Device Regulations 3
B Label Review for Class II Device US Food and Drug Administration (FDA) 0
H Re-labelling in IVDD - Re-label two products and package them as one CE Marking (Conformité Européene) / CB Scheme 5
Ed Panek 21 CFR Part 820 - FDA Label Requirements 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 8
M Manufacturer address on the label Other US Medical Device Regulations 18
F Label work instruction - Medical Devices Manufacturing and Related Processes 1
S How to decide which medical device symbols go on label and labeling? US Food and Drug Administration (FDA) 5
L Label Content Requirements under MDR regulation EU Medical Device Regulations 5
M Labeling for off-label use - Prevention of off-label use of a medical device 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
Ed Panek Label verification and validation US Food and Drug Administration (FDA) 5
T Potential Off-Label Use question 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
S Private Label Requirements, Manufacturer's Registration & Initial Importers 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
K Comparator drug with Japanese label use in Clinical trials? US Food and Drug Administration (FDA) 0
I Importer Address in addition to Manufacturer details on label EU Medical Device Regulations 13
B MDSAP 8.2.6 CH6 task 17 ANVISA 16/2013 3.2.1 - Label History in Device history record Other Medical Device Regulations World-Wide 3
P Calculating a weight for a machine for the CE label CE Marking (Conformité Européene) / CB Scheme 0
G FDA UDI markings "label" vs. "labelling" (labeling)? US Food and Drug Administration (FDA) 4
Ajit Basrur How do I label this commercial product ready for clinical study? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
D Label Legibility on Handheld Devices IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
J ISO 15223-1: Keep dry vs. humidity limitation label symbol Other Medical Device Related Standards 2
C FDA Medical Device Label Requirements - serial numbers Other US Medical Device Regulations 2
S Expiration Date (use by date) on a product label ISO 13485:2016 - Medical Device Quality Management Systems 4
S Minitab - Factor Analysis: Label on second series of data for Biplot Using Minitab Software 4
K Relabeling or Not Relabeling - Adding our internal Part Number barcode label 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
S Medical Device Research Use Only (RUO) label Other Medical Device Regulations World-Wide 4

Similar threads

Top Bottom