How to deal with changed shared components in 510k

Asia78

Involved In Discussions
#1
Dear experts,
I have a questions related to a component which is used in multiple devices (different product codes). This component was cleared in a 510k (let's call it 111) with specific product code.
Now we need to make an update to that component but we would like to do it in another 510k: this existing 510k (222) was previously indicating that the device was using the component listed in k111.
Can we submit a new 510k (333) for changes to the k222, changing also the component that was cleared in k111?
There will be no changes in the use of the k111.
 
Elsmar Forum Sponsor

Ronen E

Problem Solver
Staff member
Moderator
#2
Dear experts,
I have a questions related to a component which is used in multiple devices (different product codes). This component was cleared in a 510k (let's call it 111) with specific product code.
Now we need to make an update to that component but we would like to do it in another 510k: this existing 510k (222) was previously indicating that the device was using the component listed in k111.
Can we submit a new 510k (333) for changes to the k222, changing also the component that was cleared in k111?
There will be no changes in the use of the k111.
Not sure what you mean.
If you could share the actual k numbers I could have a look. If you're concerned about exposure you can send me a PM.
 
Thread starter Similar threads Forum Replies Date
F Circuit board FAI reports- How do you folks deal with these? Inspection, Prints (Drawings), Testing, Sampling and Related Topics 2
L How to deal with an ISO 13485 Supplier Audit nonconformance ISO 13485:2016 - Medical Device Quality Management Systems 17
MDD_QNA How to deal with FDA after not reporting anything for several years Other US Medical Device Regulations 14
M Informational Update from GOV.UK – Regulating medical devices in the event of a no-deal Brexit – UK Responsible Person Medical Device and FDA Regulations and Standards News 0
M Informational UK – Contingency legislation covering regulation of medicines and medical devices in a no deal scenario – Human Medicines and Medical Devices (Amendm Medical Device and FDA Regulations and Standards News 3
M Informational EU – Medicinal products and medical devices: Coordinated approach in case of a withdrawal of the United Kingdom from the Union without a deal Medical Device and FDA Regulations and Standards News 0
M Informational UK – Regulating medical devices in the event of a no deal scenario Medical Device and FDA Regulations and Standards News 0
M Informational UK – Businesses supplying medicines and medical devices – what to expect on day one of a ‘no deal’ scenario Medical Device and FDA Regulations and Standards News 1
M Informational Design for new product safety marking for the no-deal Brexit scenario Medical Device and FDA Regulations and Standards News 1
M Informational UK – Contingency legislation covering regulation of medicines and medical devices in a no deal scenario Medical Device and FDA Regulations and Standards News 1
N How to deal with catalog parts suppliers who refuse to submit PPAP documents? APQP and PPAP 0
M Medical Device News MHRA releases response to consultation on EU exit no-deal legislative proposals Medical Device and FDA Regulations and Standards News 0
M Pharmaceuticals News UK – Further guidance note on the regulation of medicines, medical devices and clinical trials if there’s no Brexit deal Medical Device and FDA Regulations and Standards News 0
M Medical Device News Letter to the health and care sector: update on preparations for a potential no-deal Brexit Medical Device and FDA Regulations and Standards News 0
supadrai Indemnity Letters - What's the Deal? Other Medical Device and Orthopedic Related Topics 5
M Medical Device News MHRA to consult on EU exit no-deal legislative proposals EU Medical Device Regulations 1
D How to deal with user needs when it is obvious the design meets the user need 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
P Quality Assurance and Quality Control - Which clauses of ISO 9001 deal with each? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
O How to deal with Multiple Datums - Position with respect to Multiple Datum Feature Inspection, Prints (Drawings), Testing, Sampling and Related Topics 7
J ISO 9001:2015 Clause10.2 Nonconformity and Corrective Action - Deal with Consequences ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
0 How to deal with resistance to GDP Document Control Discipline Document Control Systems, Procedures, Forms and Templates 7
R How to deal with CONFIDENTIAL documents Document Control Systems, Procedures, Forms and Templates 2
N Interesting Discussion How to Deal with Suppliers Who Refuse to Complete our ISO Survey? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 51
L How to deal with resistance from auditee(s) Internal Auditing 20
P How to deal with a Recruitment Consultant Career and Occupation Discussions 3
AnaMariaVR2 3 Ways To Deal With People Who Play Office Politics Against You Coffee Break and Water Cooler Discussions 7
J How to deal with incomplete forms Nonconformance and Corrective Action 14
R How to deal with the RM requirement of clause 17 Electromagnetic Compatibility? IEC 60601 - Medical Electrical Equipment Safety Standards Series 8
L How to deal with too many CARs (Corrective Action Requests), PARs (Preventive Action) Nonconformance and Corrective Action 25
T How to train employees to deal with external auditors? Internal Auditing 13
S Training on how to deal with Regulations, Rules, Regulations Conflicts, etc. Training - Internal, External, Online and Distance Learning 6
M Mobile Medical Platforms - How to deal with Supplier Hardware/Software Changes? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
S How to deal with non-compliant company after take over of them IEC 27001 - Information Security Management Systems (ISMS) 6
C If my location does not deal with GM - Firewall - CS1 & CS2 Question IATF 16949 - Automotive Quality Systems Standard 3
I How to deal with Behaviour Problem in the work place? Human Factors and Ergonomics in Engineering 20
J How to deal with Mental models IEC 62366 - Medical Device Usability Engineering 1
BradM Deal? Or no Deal? Coffee Break and Water Cooler Discussions 25
Marc Looking for a good deal on a boat? World News 2
S How to deal with telemarketers Funny Stuff - Jokes and Humour 2
ScottK Giving training with a vicious cold - how do you deal? Training - Internal, External, Online and Distance Learning 9
Marc Delphi to close, sell most plants under deal World News 0
J How to deal with an employee who has a bad attitude? - Employee Attitudes Coffee Break and Water Cooler Discussions 15
D X Bar Chart - How can I deal with missing values in subgroups Statistical Analysis Tools, Techniques and SPC 12
E Lets Make a Deal... The TV show - A statistical approach Coffee Break and Water Cooler Discussions 8
M Dock to Stock - How to deal with inspection status requirements Inspection, Prints (Drawings), Testing, Sampling and Related Topics 1
Marc Delphi, GM and UAW reach broad buyout deal World News 1
I How to deal with and track Customer Specific Requirements Customer and Company Specific Requirements 6
J How to deal with operators who fail to follow work instruction? Misc. Quality Assurance and Business Systems Related Topics 52
W Who is my customer? We only deal with the agent who sells our plastic resins IATF 16949 - Automotive Quality Systems Standard 14
P Is TS-16949 a 2 for 1 Deal? QS-9000 - American Automotive Manufacturers Standard 6

Similar threads

Top Bottom