Medical Device Relabeler Obligations

R

Reinheitsgebot

#1
As a relabeler of a device which is 510k cleared by the original equipment manufacturer, am I right in thinking that in order to market the device in the US I would simply be required to update my FDA listing to include the relabeled device? - i.e. there are no other obligations that the relabeler has to fulfil in order to legally market the product?

NB This is on the premise that I already have FDA establishment registration.

Many thanks for any advice!
 
Last edited by a moderator:
Elsmar Forum Sponsor
M

ManTheDan88

#2
A Relabeler defined by the FDA is someone who:

Changes the content of the labeling from that supplied from the original manufacturer for distribution under the establishment's own name. A relabeler does not include establishments that do not change the original labeling but merely add their own name.

If you are not altering the product in any way and are only adding your own name than listing the product under the OEM's 510k number should be sufficient. Here's the link from the FDA website that lists out the requirements on who must register, list, and pay fees: http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/RegistrationandListing/ucm053165.htm#relabeler
 
R

Reinheitsgebot

#4
Thank you both for your replies and information, the scenario I envisage would certainly be relabeling as the OEM's devices would be purchased by the second comapny and packed in their branded packaging which has no reference to the OEM's brand.

In this case, I assume from what I understand so far that the only requirement on the second company is for them to update their FDA product listing?

The second company may also carry out a repackaging activity for some product configurations where the OEM's devices are packed in kit packs that also include the second company's own in-house manufactured products to make what you might call a 'procedure pack' or 'system kit pack.'

For the repackaged products, my question would be what, if any, regulatory activities may be required of the second company under FDA regulations beyond updating their FDA product listing?

Many thanks again -
 

Ronen E

Problem Solver
Staff member
Moderator
#5
Repackaging and Relabeling are considered to be Manufacturing.

What needs to be done in a certain context depends on the specific device in question and its classification (as in its FDA ProCode).

What you're looking for is a (medical devices) regulatory outline for specific products - some people prepare such outlines for a living (as freelancers); If you carefully go through the FDA website you could probably do it yourself as well.
 
Last edited:
R

Reinheitsgebot

#6
I scrape a kind of living in medical device RA myself:tg:

I've already researched the FDA website and not found any requirements on relabelers beyond registering the establishment (the one in question holds its own pre-existing establishment registration), updating the product listing to include the relabeled product and paying the relevant fee for making the update.

Hence my questions here, does anyone know of any other potential requirements beyond the above - I'm not looking for the whole roadmap just an indication if anyone knows if relabelers might have to do some kind of additional product registration activity when the relabeled device is already 510k cleared? It almost seems too good to be true that the relabeler only has to update their product registration list but maybe that is the case.

I am more familiar with the EU MDD situation where the relabeller would typically apply their own CE-mark via 'own-brand labelling' which requires a Notified Body review for devices other than EU Class I.
 
M

ManTheDan88

#7
Is the product CLIA Waived? If it is you will have to get the OEM to send a letter to the FDA indicating that the Second Company needs to be added to the CLIA Registration.
 

Ronen E

Problem Solver
Staff member
Moderator
#8
Why do you bring CLIA up? I didn't see any indication in the posts that the device is related to clinical laboratory testing.
 

Ronen E

Problem Solver
Staff member
Moderator
#9
I scrape a kind of living in medical device RA myself:tg:

I've already researched the FDA website and not found any requirements on relabelers beyond registering the establishment (the one in question holds its own pre-existing establishment registration), updating the product listing to include the relabeled product and paying the relevant fee for making the update.

Hence my questions here, does anyone know of any other potential requirements beyond the above - I'm not looking for the whole roadmap just an indication if anyone knows if relabelers might have to do some kind of additional product registration activity when the relabeled device is already 510k cleared? It almost seems too good to be true that the relabeler only has to update their product registration list but maybe that is the case.

I am more familiar with the EU MDD situation where the relabeller would typically apply their own CE-mark via 'own-brand labelling' which requires a Notified Body review for devices other than EU Class I.
Hi,

You keep not telling us what the device / kit are (fair enough), which makes it difficult to give useful answers. Moreover, I'm a bit confused - are we talking just about relabeling, or about repackaging too?

Not a road map:

Unless otherwise specifically exempted, all General Controls apply to all Manufacturers and all devices. Relabelers and Repackagers are Manufacturers. The QSR (cGMP) is a General control. Are all the discussed devices GMP exempt?

Regarding 510k: Suppose that the relabeler could tag along an existing 510k. A repackager of the same device would not have it that easy, becuase changing the packaging might affect significant other characteristics of the device. The repackager would have to somehow show that it doesn't, if it doesn't. etc. etc.

The issue of 510k ownership, and of the use of an existing 510k (for listing purposes, for instance) by someone who is not the current 510k owner, has many nuances and is not always a straightforward one. I recommend you research the topic through reading the many threads we have here on that topic, or otherwise through published legislation and guidance (mostly on the FDA website).

Finally, Kit Packers / Kit Assemblers are sometimes subject to unique rules (different from those for "plain device" manufacturers).

My advice - if after fine-combing the FDA website you're still not sure what your regulatory action needs to include, hire a specialist. I have to ask you not to hire myself, otherwise this post would be self-promotion...

Cheers,
Ronen.
 
R

Reinheitsgebot

#10
Thank you for the information, in terms of GMP the relabeler in the scenario is already FDA-registered for device manufacture and works to GMP so I assume there is nothing extra to do in this respect.

The FDA guidance here:

http://www.fda.gov/medicaldevices/d...emarketsubmissions/premarketnotification510k/

- Quote from above:

"In most cases, if you are a repackager or a relabeler you are not required to submit a 510(k) if 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."

- suggests that relabelers do not need to submit a 510k in a scenario where it is only the branding of the labelling that is being changed. This would apply to most of the products in the scenario I envisage, i.e. the relabeler is just going to put the OEM product in their own cartons, preserving all the necessary labelling information but with a different brand ID on the cartons.

I take your point about repackaging validation though, this could apply where the OEM's devices are being packed into system kits together with the second company's devices so I assume this could be case I guess where a new 510k is required.

Many thanks - RH
 
Thread starter Similar threads Forum Replies Date
shimonv Medical Device Relabeler Requirements 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
rob73 UK Medical Device Regulations Forum - UK MDR Elsmar Cove Forum Suggestions, Complaints, Problems and Bug Reports 1
S Philippines CMDL (Certificate of Medical Device Listing) Elsmar Cove Forum ToS and Forum Policies 0
J 21 CFR 821 Medical Device Tracking Requirement 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
S Iraq Medical Device registration Other Medical Device Regulations World-Wide 0
R Medical Device Software Certification IEC 62304 - Medical Device Software Life Cycle Processes 1
D Class IIB Medical Device Accessories - OTS Tablets Other Medical Device Regulations World-Wide 1
F Change to Formulation due to Reach (China Medical Device Regulations) China Medical Device Regulations 0
R Accelerated Aging - Creating test samples - Implantable medical device Question Other Medical Device Related Standards 4
T Clinical evaluation of a new medical device EU Medical Device Regulations 0
7 Iraq Medical Device Chemical Regulations Other Medical Device Regulations World-Wide 0
J UCLA extension Medical Device Engineering Program Training - Internal, External, Online and Distance Learning 0
Q Storing and developing SAMD (Software as a Medical Device) in the Cloud IEC 62304 - Medical Device Software Life Cycle Processes 2
I ISO 2233:2000 Question - Medical Device Shipping/Transportation Validation Other ISO and International Standards and European Regulations 1
R Identify Medical Device characterstics as Annex C of ISO 14971 Risk Management ISO 14971 - Medical Device Risk Management 5
O ANATEL certification of Medical Device Other Medical Device Regulations World-Wide 0
Ajit Basrur FDA News Harmonizing and Modernizing Regulation of Medical Device Quality Systems (7-2020) US Food and Drug Administration (FDA) 0
A Legal Manufacturer Medical device US Food and Drug Administration (FDA) 2
S Looking for Quality Content to Build Medical Device Curriculum - Concept to Commercialization Training - Internal, External, Online and Distance Learning 4
A Interpretation of GMP Requirements for class 1 medical device manufacturer (device GMP exempt, only General controls applicable) 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
A Legal Manufacturer of a medical device Vs Legal Manufacturer of MDSW EU Medical Device Regulations 7
T Loaded spring device - Active medical device? EU Medical Device Regulations 1
MDD_QNA Medical Device Software - Is a Help Button required? IEC 62304 - Medical Device Software Life Cycle Processes 1
H MDD Article 12 Labeling for Class IIa Medical Device - Please Advise EU Medical Device Regulations 3
J Does Pakistan Medical Device Import License allows parallel import? Other Medical Device Regulations World-Wide 0
K China Medical Device Labeling requirements - Language China Medical Device Regulations 3
F Software as a Medical Device (SaMD) Technical File Requirements Manufacturing and Related Processes 1
A Sample Agreement available for Outsourcing Medical Device Design activity? ISO 13485:2016 - Medical Device Quality Management Systems 1
dgrainger Informational EU medical device website change from 'Growth' to 'Health and Food Safety' (6/2020) Medical Device and FDA Regulations and Standards News 0
B How to classify a medical device based on MDR? EU Medical Device Regulations 3
J Need for a cleanroom in the manufacture of a medical device for a clinical trial EU Medical Device Regulations 4
A Software as Medical Device (SaMD) definition and its applicability Other Medical Device and Orthopedic Related Topics 4
F Labelling requirements for a medical device containing fragrance allergens EU Medical Device Regulations 3
A Medical device Reporting : Good Faith Effort for Additional information Other US Medical Device Regulations 2
A Medical Device Vigilance decision tree for Japan for class 2 devices. Japan Medical Device Regulations 1
I How to classify a medical device based on FDA? 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
Edward Reesor EU Authorized Representative for a Class I Medical Device CE Marking (Conformité Européene) / CB Scheme 11
E IEC 60601-1 - Unearthed Medical Device Metal Parts IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
U Medical Device Design finalization testing ISO 13485:2016 - Medical Device Quality Management Systems 2
S FDA Requirements for Medical Device Label Reconciliation 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
J Medical Device Registration in the UAE MoH Other Medical Device Regulations World-Wide 2
JoCam Medical Device Distribution in the UK EU Medical Device Regulations 6
B FDA-Medical Device Reporting (MDR )procedure compliant with 21CFR section 803 US Food and Drug Administration (FDA) 0
R An indication that the device is a medical device (MDR, Annex 23.2q) - applicable for accessories? EU Medical Device Regulations 5
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
W Direct to customer export of medical device (class I: prescription lenses + frame) US Food and Drug Administration (FDA) 2
J Validity / outcomes measure for custom made medical device ISO 13485:2016 - Medical Device Quality Management Systems 2
S Regulatory job in pharma vs. medical device US Food and Drug Administration (FDA) 16
S Regulatory job in pharma vs. medical device CE Marking (Conformité Européene) / CB Scheme 0

Similar threads

Top Bottom