Re-packager/Re-Labeler - FDA Registration question

Z

znelson

#1
My company is planning to register as a re-packager/re-labeler for a Class II cardiac monitor. My question is regarding how we should be registering our facility with FDA (we are already registered as a manufacturer).

Clearly we will need to register as a re-packager/re-labeler of the cardiac monitor [510(k)]. However, is it necessary to register the 510(k) of the disposable ECG electrodes that will be used with the monitor? We are not changing the immediate packaging or labeling of the ECG electrode pouches. We plan to remove the sealed pouches from the OEM ECG packaging and place the electrode pouches with the re-packaged/re-labeled cardiac monitor.

Does anyone have any experience with a situation like this? Thanks for your help.
 
Elsmar Forum Sponsor
M

MIREGMGR

#2
It sounds to me as if you'll be a kit assembler, not a repackager.

You might additionally be a relabeler depending on whether you leave the existing labeling and perhaps add a supplemental label to identify yourself, or instead overlabel or otherwise entirely replace the existing labeling with your own labeling.

You aren't "changing your registration". There aren't different types of registration. What you'll be doing, rather, is declaring as you list each of your products, what your activity is in regard to that product. You'll check off each activity-category that applies.
 

Sheila1

Starting to get Involved
#3
I had a question about relabelers and registration/listing. I understand that if you leave the original OEM label in place and add a sticker saying "Manufactured for" or "Distributed by" then you are not a relabeler. I also understand that if you completely replace the label or over-label and label the device in your own name, you are a relabeler (and possibly a manufacturer). However, do you become a relabeler and need to list the device if you over-label or replace the label and the new label has the "Manufactured for" or "Distributed by" designation (the original manufacturer is aware of this)? How would this be different from a private labeling scenario where the OEM does the labeling in the distributor's name?

Thanks!
 

Ronen E

Problem Solver
Staff member
Moderator
#4
I had a question about relabelers and registration/listing. I understand that if you leave the original OEM label in place and add a sticker saying "Manufactured for" or "Distributed by" then you are not a relabeler. I also understand that if you completely replace the label or over-label and label the device in your own name, you are a relabeler (and possibly a manufacturer). However, do you become a relabeler and need to list the device if you over-label or replace the label and the new label has the "Manufactured for" or "Distributed by" designation (the original manufacturer is aware of this)? How would this be different from a private labeling scenario where the OEM does the labeling in the distributor's name?

Thanks!
Hello Sheila and welcome to the Cove :bigwave:

You are in the grey area. To remove doubt, you better have a written contract with the OEM clearly stating that this is a private label arrangement and that they continue to bear all regulatory responsibility, ready to show to FDA investigators. To avoid complications I would also put in place a written agreement controlling the contents (and other properties) of the over-label and the way in which they can be changed through documented agreement between your company and the OEM.

In some specific circumstances you might get away with less (given some good will on FDA's part), but do you really want to take the risk?
 
Last edited:

shimonv

Trusted Information Resource
#5
However, do you become a relabeler and need to list the device if you over-label or replace the label and the new label has the "Manufactured for" or "Distributed by" designation (the original manufacturer is aware of this)? How would this be different from a private labeling scenario where the OEM does the labeling in the distributor's name?
Ronan, I liked what you wrote.
Sheila1, just to add form my understanding:
1. If you over-label than you are a relabeler.
2. If the manufacturer removes its own identification label and put the "Manufactured for" label with your information then its a private label scenario. The quality agreement between you and the manufacturer will determine who will bear the regulatory responsibility - you or the OEM.

So to answer your questions: For the fist question the answer is "yes". For the second question: Outwardly it looks like a private label, but if the manufacturer does all the work and assumes the regulatory responsibility than that puts you in a state of a distributor with no regulatory burden.

I hope it's clear & make sense.

-Shimon
 

Sheila1

Starting to get Involved
#6
OK. That makes sense. If you do it yourself, you are a relabeler because you need quality controls to ensure the label is accurate. It was a bit unclear because of the "Manufactured for" indicating it is a distribution scenario.

Thanks!:thanx:
 
#7
I’ve read through here and I’ve got the understanding of where I think my company belongs, but here’s where I’m lost. We take a bulk pack device that is sold nonsterile and relabel it repackage it and sterilize it. We have a PLD agreement with the manufacturer and they know we do this. We import the device from Germany. The device was 510(k) approved for user sterilization (moist heat) and we are doing Gamma. What do we need to have in place to satisfy the fda? Thanks in advance.
 
Thread starter Similar threads Forum Replies Date
S Contract Packager or Repackager? And can client assume responsibility? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 0
E Original Brand Labeler (OBL) in China China Medical Device Regulations 2
S Is company “A” a contract manufacturer, a labeler, or a repackager 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
Q Medical Device Establishment Registration/Listing for Foreign Private Labeler Other US Medical Device Regulations 8
M Medical Device Private Labeler Responsibilities 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
C UDI (Unique Device Identifier) Definition of Labeler Other US Medical Device Regulations 1
M Free XY Chart Labeler for Excel Excel .xls Spreadsheet Templates and Tools 1
pbojsen OEM / OBL "Private labeler" agreement template? EU Medical Device Regulations 9
Q FDA: File an electronic Registration of Drug Establishment/Labeler Code 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
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
N FDA UDI - Label vs. Labeling - Does the insert need to include UDI? Other US Medical Device Regulations 0
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
gunnyshore Form FDA 3500A MedWatch eSubmitter 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
Watchcat FDA Webinar Series - N95 Respirators Other US Medical Device Regulations 0
M Off-Label Use - Clarification of FDA Policy US Food and Drug Administration (FDA) 1
J Sub-supplier change from manual to automated process - same specs - Report to FDA? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
C FDA Establishment registration - Buying some medical devices from another manufacturer Medical Device and FDA Regulations and Standards News 5
I How to classify a medical device based on FDA? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
dinaroxentool Question about FDA Classification of a Device 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
S The US FDA requirements on Disposal of a medical device US Food and Drug Administration (FDA) 1
S FDA Requirements for Medical Device Label Reconciliation 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
S What is considered a "core algorithm"? (From an FDA guidance document) Medical Information Technology, Medical Software and Health Informatics 4
B FDA-Medical Device Reporting (MDR )procedure compliant with 21CFR section 803 US Food and Drug Administration (FDA) 0
Stoic Are any medical device companies using the 2011 FDA process validation guidance instead of GHTF/SG3/N99-10:2004? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
D ISO 13485, FDA 21 CFR 820 and Auditing the Accounting Department ISO 13485:2016 - Medical Device Quality Management Systems 5
S FDA's E submitter - For clinical electronic thermometer Medical Device and FDA Regulations and Standards News 6
J FDA wants electrical safety testing on battery powered medical device US Food and Drug Administration (FDA) 11
A FDA and NB audit of Engineering Drawings in DHF and DMR. Medical Device and FDA Regulations and Standards News 1
D FDA De Novo Cover Letter - What is expected US Food and Drug Administration (FDA) 3
Ed Panek 21 CFR Part 820 - FDA Label Requirements 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 8
J Mislabeling - Consider this an FDA notified recall? CFR 806.10 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
O Hospital-Developed, In-House Device - FDA Clearance? Other US Medical Device Regulations 19
D FDA Approved Class II Medical Device? Other US Medical Device Regulations 11
R When does the FDA consider a component a medical device? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 17
N Risk Management besides mandated FDA requirements 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
M Informational US FDA – Ear, Nose, and Throat Devices; Classification of the Self-Fitting Air-Conduction Hearing Aid Medical Device and FDA Regulations and Standards News 0
L UDI Requirments Gap Analysis - EU MDR vs FDA CFR EU Medical Device Regulations 8
M Informational US FDA – Modifications to the List of Recognized Standards, Recognition List Number: 052 Medical Device and FDA Regulations and Standards News 0
M Informational US FDA Draft Guidance – Breast Implants – Certain Labeling Recommendations to Improve Patient Communication Medical Device and FDA Regulations and Standards News 0
M Looking for third party reviewers for FDA submissions US Food and Drug Administration (FDA) 2

Similar threads

Top Bottom