SBS - The best value in QMS software

Requirements for Private Labeling a Class III (PMA) Medical Device in the US

T

tehuff

Involved In Discussions
#1
#1
What are the requirements for private labeling a Class III (PMA) device in the US? There are 2 scenarios: 1) device itself is identical and only the label is changing to reflect the distributor's name instead of the manufacturer and 2) label changes as described in (1) and minor device modifications (eg. different packaging configuration or bottle).

Thanks!
 
12 questions to ask before buying a QMS
Elsmar Forum Sponsor
T

tehuff

Involved In Discussions
#3
#3
Let me change my question a bit...hopefully someone out there has done this before. Does the manufacturer need to get approval for the private label device if the only difference is that the label is changed to reflect the new distributor/retailer? Is this a new device that requires a PMA supplement?
Thanks!
 
C

cher32

Registered
#4
#4
I have a similar question to above.
What are the requirements for private labeling a Class III (PMA) IVD in the US? The device itself is identical and only the label is changing to reflect the distributor's name instead of the manufacturer. Can this be done? Anyone had any experience of how to do this?
 
I

indubioush

Quite Involved in Discussions
#5
#5
Sec. 807.20 Who must register and submit a device list?

(a) An owner or operator of an establishment not exempt under section 510(g) .... including any person who:

(3) Repackages or relabels a device;



Sec. 807.81 When a premarket notification submission is required.

....

(2) The device is being introduced into commercial distribution for the first time by a person required to register, whether or not the device meets the criteria in paragraph (a)(1) of this section.
 
Ronen E

Ronen E

Problem Solver
Staff member
Moderator
#6
#6
cher32 said:
I have a similar question to above.
What are the requirements for private labeling a Class III (PMA) IVD in the US? The device itself is identical and only the label is changing to reflect the distributor's name instead of the manufacturer. Can this be done? Anyone had any experience of how to do this?
Click to expand...
By default all the manufacturer's responsibilities would fall to the (legal) person whose name and address appear on the labeling - the distributor in this case. I've heard of class II cases where the OEM (Contract Manufacturer) kept most responsibilities (if you search for old posts by MIREGMGR, sometime between 2010 and 2016, you might find something), but I'm not familiar with the class III situation in this context. I guess you need to carefully read 21 CFR part 814 first, and maybe look into PMA-related guidance.
 
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
S Private Label Requirements, Manufacturer's Registration & Initial Importers 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
Q Private Label Listing Requirements for Medical Devices Other US Medical Device Regulations 1
J Biocompatbility testing on Class 1 device requirements Other US Medical Device Regulations 2
Le Chiffre Online training available for ISO/IEC 17021-1: Requirements for bodies providing audit and certification of management systems Training - Internal, External, Online and Distance Learning 2
S What are the International Forging Requirements for Nitrogen Strengthened Stainless Steel? EU Medical Device Regulations 3
M Supplier requirements - Major supplier is a Non-Profit registered with ICCBBA (FDA UDI) Supply Chain Security Management Systems 7
R Components to a finished medical device, MDR requirements Other US Medical Device Regulations 1
S Distributor requirements in US 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
K AS9100D 8.2.1 Review Requirements for Products and Services AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 4
F Environmental Requirements E-Lab General Measurement Device and Calibration Topics 0
T 21 CFR 820.20 - Quality Planning Requirements? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
N Composites - Freezer sensor requirements Manufacturing and Related Processes 2
A Requirements for Contract Manufacturers Other Medical Device and Orthopedic Related Topics 3
O Informational Ford Motor Company Customer Specific Requirements for IATF 16949:2016 - 08 Jan 2021 Customer and Company Specific Requirements 0
M IEC 61010-1 requirements for motors Other Medical Device Related Standards 0
J Requirements for registering Alcohol Wipes (70% IPA) in Canada Medical Device and FDA Regulations and Standards News 4
Ed Panek IFU Contact Requirements - FDA and MDD/MDR US Food and Drug Administration (FDA) 1
N German National Requirements - Safety Officer/Authorised Rep Other Medical Device Regulations World-Wide 0
S Traceability of requirements to design and risk Design and Development of Products and Processes 3
F USB powered handheld medical device - Isolation requirements IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
A Class I (exempt) testing requirements Other Medical Device Related Standards 0
J Saudi Arabia Technical File Requirements Other Medical Device Regulations World-Wide 1
N Help with basic understanding of Competence requirements ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
A Test requirements for marketing in US when RATED values are not of US IEC 60601 - Medical Electrical Equipment Safety Standards Series 5
John Broomfield Vote - Should ISO9004 Become a Requirements Standard? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
A Registration requirements for custom branded device 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 9
A User interface Language Requirements - EU MDR EU Medical Device Regulations 1
A Which guidance do you use for guiding the requirements of IFU for 510(k) submission? Medical Device and FDA Regulations and Standards News 5
O IATF 16949 News Ford Motors Customer Specific Requirements Update - Nov 2020 IATF 16949 - Automotive Quality Systems Standard 5
S ISO 9001 Clause 8.2.3 - Review of the requirements for products and services in a Cafe ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
T Temperature Requirements For In House Calibration - AS9100 AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 16
B Gage calibration frequency, ISO and IATF - What are the requirements Calibration Frequency (Interval) 3
E Contract manufacturer FDA requirements foreign company US Food and Drug Administration (FDA) 6
JoCam Rental, service & installation - regulatory requirements EU Medical Device Regulations 2
G MDR translation requirements EU Medical Device Regulations 3
D Change Approval Requirements - Does every change need formal customer approval? Design and Development of Products and Processes 17
D Labeling requirements for reagents, etc ISO 13485:2016 - Medical Device Quality Management Systems 4
I Additional National requirements for placing MD in the EU countries EU Medical Device Regulations 7
G Tool tracebility and First calibration requirements for aerospace (AS9100) organisation AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
P Managing How PPAP Requirements are Communicated in the Manufacturing Process and to Suppliers APQP and PPAP 5
T Controlled Forms or documented requirements for records? ISO 13485:2016 - Medical Device Quality Management Systems 2
E SIP/SOP requirements for USB port used for charging IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
S Requirements to obtain ISO 50001 Certification ISO 14001:2015 Specific Discussions 2
L Exemption from the Regulation COVID-19 and QMS requirements EU Medical Device Regulations 2
A ANSI/AAMI versions of 60601-1-2 and related testing requirements Other Medical Device Related Standards 3
P Equipment 21 CFR 820.70(g) - User Requirements Document for Off the shelf equipment 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 7
S PSW - Requirements for "off-the shelf" component that has multiply manufacturing locations Off the Shelf Item Manufacturing and Related Processes 1
D IATF16949 - Interpretation of Customer Requirements clauses IATF 16949 - Automotive Quality Systems Standard 3
S Customer Specific Requirements (CSR) not signed/approved IATF 16949 - Automotive Quality Systems Standard 17
B FCA US IATF 16949 Customer Requirements updates Customer and Company Specific Requirements 3

Similar threads

Top Bottom