How can we change a device trade name in 510(k) summary?

#1
Hi,
My company received 510(k) clearance on a product
The product name was changed between submission time and marketing time
Is there a way to change the product trade name in 510(k) summary without re-submitting?

Thank you,
 
Elsmar Forum Sponsor
Thread starter Similar threads Forum Replies Date
dgrainger Informational MHRA's Software and AI as a Medical Device Change Programme UK Medical Device Regulations 0
S Reseller Request to Change UPC on Medical Device via Re-labeling Medical Device and FDA Regulations and Standards News 5
N ISO 13485 7.3.9 Change control in medical device software ISO 13485:2016 - Medical Device Quality Management Systems 6
R Medical Device - Change manufacturing plant Design and Development of Products and Processes 6
F Change to Formulation due to Reach (China Medical Device Regulations) China Medical Device Regulations 0
D Class 3 Device - Change of supplier of material Canada Medical Device Regulations 6
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
K Is a change that fixes a recalled device significant? Medical Device and FDA Regulations and Standards News 2
Pjservan Change on Medical Device Classifications - Dental Crowns Other Medical Device Regulations World-Wide 5
D Are medical device companies required to document every change made to their website? Document Control Systems, Procedures, Forms and Templates 2
K Reporting a Change of Contract Manufacturer for a 510(k) cleared device Other US Medical Device Regulations 5
S Device name change and label color change EU requirement? Other Medical Device Regulations World-Wide 6
L Managing design projects: New Medical Device Project or Change Design and Development of Products and Processes 1
R How long to wait for Notified Body Response - Potentially significant change to a medical device CE Marking (Conformité Européene) / CB Scheme 6
S Medical Device - Change / Variations to a Medical Device EU Medical Device Regulations 4
T Change to the FDA cleared device (ours) - Submission or Letter to file? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 8
R SaMD - Software as a Medical Device - Software change control form ISO 13485:2016 - Medical Device Quality Management Systems 3
T Change to Country of Origin on Medical Device Labeling Other Medical Device Regulations World-Wide 0
J South Korea, MFDS - Medical Device Change Management Other Medical Device Regulations World-Wide 5
J Class 1 Medical Device ECR (Engineering Change Request) Changes 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
TheMightyWife Address Change - Medical Device Packaging Labelling Requirements EU Medical Device Regulations 7
I Another design change or new product? IVD device ISO 13485:2016 - Medical Device Quality Management Systems 6
C Vietnam - Authorized Medical Device Representative Change Other Medical Device Regulations World-Wide 10
M New Medical Device Accessory with New Function - Is this a major change? Other Medical Device Regulations World-Wide 3
H Change of a medical device sterilization dose - New 510(k) necessary? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
C Medical Device Website Change Control ISO 13485:2016 - Medical Device Quality Management Systems 3
J PMA Device - Lot # change in New ERP Software - What are the FDA Requirements 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 0
M Medical Device Change Requirements - Malaysia Registered Products Other Medical Device Regulations World-Wide 4
N Is a new 510K required for change of manufacturing location for an existing device? US Food and Drug Administration (FDA) 1
MDD_QNA Medical Device PCB component change IEC 60601 - Medical Electrical Equipment Safety Standards Series 4
JoCam Validation of a change to a CE Marked Medical Device EU Medical Device Regulations 4
S Change of Medical Device Company Registered Address - Implications Quality Manager and Management Related Issues 3
M Making a change to an approved Medical Device Other US Medical Device Regulations 9
J Change to Outer Packaging Material/Supplier - Sterile, Class IV Device Other Medical Device Related Standards 4
H FDA/PMA/Medical Device/Before submission/Manufacturing facility change US Food and Drug Administration (FDA) 1
B Class II and Class III Medical Device Amendment for Change in Location? Canada Medical Device Regulations 2
T Class II Medical Device with Software - Change to Computer 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
B How to change the FDA Device Registration and Listing Module - Owner/Operator Other US Medical Device Regulations 10
G Validity for Thailand Medical Device License and can change Distributor thereafter? Other Medical Device Regulations World-Wide 3
D Change in Medical Device Shipping Box - Transport Test Required? Other Medical Device Related Standards 1
G How do I change the Medical Device Product Code in FDA site? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 9
A Medical Device DHF (Design History File) - One per Design Change? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 17
J Class IIa Medical Device - Can I over label to change an address? ISO 13485:2016 - Medical Device Quality Management Systems 3
Z KFDA (Korea) Device Change Regulations - What are 32 Types of Changes Exempted? Other Medical Device Regulations World-Wide 2
shimonv Deciding When to Submit a 510(k) for a Change to an Existing Device 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 17
A Change Medical Device Class from Class II to Class I 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 8
sagai New Draft Guidance - When to Submit a 510(k) for a Change to an Existing Device 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
M Class I Medical Device - 1st notification and change notification EU Medical Device Regulations 4
D Regulations for Relabeling of Medical Device for Address Change ISO 13485:2016 - Medical Device Quality Management Systems 1
R EU Medical Device Change Decision Tree (when to notify the NB) EU Medical Device Regulations 4

Similar threads

Top Bottom