SBS - The Best Value in QMS software

Relabeling or Not Relabeling - Adding our internal Part Number barcode label

#1
Would adding a barcode label with our internal PN onto a vendor's product box be considered relabeling under FDA regulations?.
The vendor's product label remains visible and is not over-labeled; and none of the vendor's label details are changed.

If it is relabeling, do need to add our own UDI barcode label to the product?
 
Elsmar Forum Sponsor
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
C Relabeling Product Manufactured by the OEM 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
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
U Adding another Subcontractor EU Medical Device Regulations 3
N Adding unclassified product to the medical device registration US Food and Drug Administration (FDA) 1
S Complexity Rating - CB adding another audit day for "high complexity" AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 6
E Adding models to an approved Russian Registration Certificate Other Medical Device Regulations World-Wide 1
gunnyshore Adding a new facility - do I need to submit an amendment to the MDL or MDEL, or both? Canada Medical Device Regulations 3
D Adding a Class I to a sample box Canada Medical Device Regulations 5
K Adding the Notified Body Number CE Marking (Conformité Européene) / CB Scheme 2
O Adding ISO 13485 to an AS9100 QMS ISO 13485:2016 - Medical Device Quality Management Systems 13
P Adding "new" medical device to existing CER - under MDD CE Marking (Conformité Européene) / CB Scheme 1
F Adding a medical device in another medical device package EU Medical Device Regulations 2
A Adding Remote Site to Current IATF 16949 Certification IATF 16949 - Automotive Quality Systems Standard 2
S Adding Value prior to signing EASA Form 1 EASA and JAA Aviation Standards and Requirements 5
D Adding a new site to 13485 Certification ISO 13485:2016 - Medical Device Quality Management Systems 4
S Adding claims on medical device labelling 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
J Adding a UDI Compliant Label to previously manufactured devices 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 0
P Adding an additional distributor to a current Mexico Medical Device Registration Other Medical Device Regulations World-Wide 0
4 Adding a new Company - ISO 9001 Design Exclusion Design and Development of Products and Processes 1
L IATF 16949: Adding a Remote Location between certifications IATF 16949 - Automotive Quality Systems Standard 2
T Adding an adapter to a Torque Meter to change the Range Capability, Accuracy and Stability - Processes, Machines, etc. 6
R Coexisting Investigational Use and CE-Mark - Adding a new Indication EU Medical Device Regulations 4
K Adding a New Site to Our ISO 13485 Certification ISO 13485:2016 - Medical Device Quality Management Systems 9
C Adding information to Labels - Class II Medical Devices US Food and Drug Administration (FDA) 1
K Medical device procedure tray - Adding products in Custom packs Other Medical Device and Orthopedic Related Topics 3
D Adding an extra Label on an Ethylene Oxide Sterilized Box ISO 13485:2016 - Medical Device Quality Management Systems 3
E Adding a "Scope Statement " to my Quality Policy ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
W Quality for value adding or certification? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 23
somashekar Adding an other process into the system - Authorised Economic Operator (AEO) Scheme ISO 13485:2016 - Medical Device Quality Management Systems 4
Z Adding 1% error to data in a column in Minitab Using Minitab Software 3
M Is 510k Required for Adding a section on use of Disinfectants to Product Manual? US Food and Drug Administration (FDA) 3
D Adding PPAP forms to the ISO procedures Document Control Systems, Procedures, Forms and Templates 2
S FDA CDRH Premarket Review Submission Cover Sheet - adding more products 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
B What to do when adding new Proprietary name under same 510(k) Other US Medical Device Regulations 2
M PPAP requirements when adding Part Transfer Robots between Machines APQP and PPAP 1
M Adding AS9100C Lead Auditor Certification to an IRCA ISO 9001 LA Certification AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
B Need help in adding second location to FDA Registration Other US Medical Device Regulations 4
K Adding a Disclaimer on an FMEA FMEA and Control Plans 4
M Adding Bizminer's Industry Financial data to my Peer Company Comparison Manufacturing and Related Processes 0
D Rounding Numbers - Adding numbers in Excel - I want the average Excel .xls Spreadsheet Templates and Tools 3
F Implementing ISO 11135 - Facilities Conditions - Adding ETO Sterilization Other Medical Device Related Standards 4
Q Adding to our A2LA Scope of Accreditation General Measurement Device and Calibration Topics 2
A ISO 9001 company now adding Welding to the Scope - What needs to change? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
marmotte Adding a Funct. Earth. to a class II / BF device...retest needed? IEC 60601 - Medical Electrical Equipment Safety Standards Series 4
M Document Changes not affecting the process - Adding Logos, etc. Document Control Systems, Procedures, Forms and Templates 8

Similar threads

Top Bottom