Relabeling Product Manufactured by the OEM

celticfrosting

Starting to get Involved
#1
Hello, I have a question that I’m hoping someone here can help me with. Our company wants to put a label onto a product made for us by the OEM. The product falls under Class II for the FDA and IIa within Europe. The OEM is the 510k holder and sells this product globally. Can our company apply labels that list us as the manufacturer and not mention anything about the OEM on it? The design, use and indications will remain the same. Any advice is appreciated. Thanks.
 
Elsmar Forum Sponsor

Marc

Fully vaccinated are you?
Staff member
Admin
#2
A quick "bump". My Thanks in advance to anyone who can help with this one.
 

celticfrosting

Starting to get Involved
#3
Also, I would like to note:
Our company will be repackaging these instruments. There will be no labeling on the packaging when we receive it from the OEM.

We will add our own instructions for use which mimics the OEMs IFU except only our name will be on it.

We intend to state our company as the manufacturer.

As far as regulatory responsibility: I believe we will be taking full control of as manufacturer though I have read about relabeler and repackager responsibilities that I'm not sure may or may not apply just as easy.

What I'm trying to solve is if we can use the OEMs 510(k) or if we have to submit a new one.
 
Last edited:
#4
If your OEM handles everything (manufacturing, packaging, labeling) EXCEPT distribution to end users (i.e., you are using their 510(k) and function merely as a private-label brand of their product), then you can leave their name off and only say "Distributed By" [your company name].

Since you are repackaging/relabeling the above situation does not apply. You are a repackager/relabeler. You are not a full-blown manufacturer (i.e., you don't need Design Controls and such).

Regarding the 510(k), here's what the FDA has to say:
When a 510(k) is Not Required
[...]
4. In most cases, if you are a repackager or a relabeler and the existing labeling or condition of the device is not significantly changed. The labeling should be consistent with the labeling submitted in the 510(k) with the same indications for use and warnings and contraindications.

Earlier on in the document it states:
The following four categories of parties must submit a 510(k) to the FDA:
[...]
3. Repackers or relabelers who make labeling changes or whose operations significantly affect the device.
Repackagers or relabelers may be required to submit a 510(k) if they significantly change the labeling or otherwise affect any condition of the device. Significant labeling changes may include modification of manuals, such as adding a new intended use, deleting or adding warnings, contraindications, etc. Operations, such as sterilization, could alter the condition of the device. However, most repackagers or relabelers are not required to submit a 510(k).

Reference:
fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/PremarketSubmissions/PremarketNotification510k/default.htm

That said, you are likely OK using their 510(k), registering as a repackager, and building out your QMS accordingly.

Thanks,
~Josh
 
A

aadel

#6
Would they still have to register as an initial importer? Or would they be simply considered a domestic wholesale distributor? I am a bit confused how to label our company in the eyes of the FDA, in particular we are conflicted on the matter of paying the $4.6k annual fee to register with the FDA.


-aadel
 
Thread starter Similar threads Forum Replies Date
S New to Repackaging/Relabeling! 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
K Relabeling an existing medical device in the field? Other US Medical Device Regulations 6
K Relabeling or Not Relabeling - Adding our internal Part Number barcode label 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
A Design Control for Relabeling and Repackaging 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 6
D Relabeling due to FDA Detention Notice Manufacturing and Related Processes 6
D Regulations for Relabeling of Medical Device for Address Change ISO 13485:2016 - Medical Device Quality Management Systems 1
R FDA & Recall (voluntary) - Relabeling devices from a different distributor 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 7
M R&R Studies - how many? per product? Reliability Analysis - Predictions, Testing and Standards 3
A Eudamed actor registrations if you change AR for MDR product EU Medical Device Regulations 0
S Reliability issue - Frequent component failure of the product Reliability Analysis - Predictions, Testing and Standards 0
R Statistical Methods for comparing test and reference product equivalence for quality attributes US Food and Drug Administration (FDA) 3
T Do I need to add non-product related service providers to my ASL? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 12
L How to deal with the model number symbol for X-RAY PRODUCT Other Medical Device Related Standards 1
B Establishment and Product Registration Procedure - UK & EU UK Medical Device Regulations 0
I Is SRN required for a contract manufacturer (CE-Marking product)? EU Medical Device Regulations 2
M Process & Product Characteristic in Control Plan FMEA and Control Plans 17
L 1 product multiple factories EU Medical Device Regulations 0
C Product Lifetime on Labeling 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
B Acquired Medical Device Product Line - Documentation Requirements for Device Master Record ISO 13485:2016 - Medical Device Quality Management Systems 7
P API Q1 - Monogram Product & API 4F - Proof Load Test Oil and Gas Industry Standards and Regulations 3
R CE marked product sold in UK no EU rep CE Marking (Conformité Européene) / CB Scheme 2
JoCam On-product labels for Medical Devices EU Medical Device Regulations 3
Awais How to mistake proof - Shipping Orders with Shortages - Product Quantity Accountability mismatch with Job Traveller? Manufacturing and Related Processes 17
L Product and process Deviation procedure Manufacturing and Related Processes 1
H Using/Selling power banks with your product as a "mobile version" CE Marking (Conformité Européene) / CB Scheme 3
H Electronic care product on patient bed side - Flammability requirements (62368-1) Hospitals, Clinics & other Health Care Providers 0
B Design Responsibilities for Mature Acquired Product Lines ISO 13485:2016 - Medical Device Quality Management Systems 3
D Dental application - medical product or not? Other US Medical Device Regulations 8
Q Product Quality vs Product Defects Manufacturing and Related Processes 4
J Verification of purchased product / supplier questionnaires ISO 13485:2016 - Medical Device Quality Management Systems 2
E Any template/ form of Monitoring and Measurement of Processes and product to ISO 13485? ISO 13485:2016 - Medical Device Quality Management Systems 1
S Product Code 510(k) exemption US Food and Drug Administration (FDA) 1
M REACH assessment of PCBA/finished product REACH and RoHS Conversations 2
J Validity of CE mark on distributed product when company ceases trading EU Medical Device Regulations 3
Q News cradle to grave - Product life cycle ISO 14001:2015 Specific Discussions 5
J Using of CE marking - Two CE markings on the product CE Marking (Conformité Européene) / CB Scheme 5
W Final Report re: Market withdrawal of radiation-emitting product Other US Medical Device Regulations 0
M Combination Product - New MAA EU Medical Device Regulations 0
pbojsen ISO 13485 Requirements versus FDA product classification and GMP exemptions - Audits ISO 13485:2016 - Medical Device Quality Management Systems 4
Z REACH compliance for low volume product REACH and RoHS Conversations 1
chris1price Notified Body responsible for product safety under MDD? EU Medical Device Regulations 4
S Does a refurbished product required a new UDI? US Food and Drug Administration (FDA) 3
lanley liao How to understand and master the requirements of each section in API monogram product. Oil and Gas Industry Standards and Regulations 5
H Verification Process for the existing MDS Product IEC 62304 - Medical Device Software Life Cycle Processes 5
A UDI for product already packed up EU Medical Device Regulations 0
A Migrating from whole product CE marking to modular approach CE Marking (Conformité Européene) / CB Scheme 5
H Medical device Product Registration Registrars and Notified Bodies 2
A Can a power Supply be an accessory to a medical device, if it is an 'off-the-shelf' product. IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
M Extension to shelf life of new product under MDR EU Medical Device Regulations 1
lanley liao Are there guidelines for application of all API monogrammal product? Oil and Gas Industry Standards and Regulations 2

Similar threads

Top Bottom