510(k) submission - Which name should I use in the submission?

#1
Hello all,

I'm almost ready to submit our first 510(k) but I have a situation that I never saw before. Our company headquarters are in US and the manufacturing office in France. The Small Business designation was done using the name and address of the headquarters, however I don't know if now I have to submit the 510(k) using the headquarters address or the manufacturing office address.
Also, the name of the company is a little different, EXAMPLE in

US: Peter Piper, Inc., d/b/a. Picked

FR: Picked a peck of pickled peppers S.L.

Witch name should I use in the submission? Remember, the small business designation was done using the US name.

Thank you
 
Elsmar Forum Sponsor

shimonv

Trusted Information Resource
#2
The name of the legal entity, which is the one that appears on the IFU, label, and software (if used) - should appear in the 510(k) application. And, of course, to get the discount for small businesses - it should match the details on the Small Business designation application.
 

Watchcat

Trusted Information Resource
#3
I think the name on the submission mostly identifies legal responsibility for the accuracy of the information in the submission and not much else. I think the submitter also has to be legally able to submit an application for the device (i.e., owns the IP or has licensed it).

The original submitter might never even be manufacture the device for the market, once it is cleared, if they are a startup that is acquired shortly after clearance. So the manufacturing site is not that important. It is important later, when it is manufacturing an FDA-cleared device for sale on the US market. But then it will registered as an Establishment, which is a separate thing from a 510(k) applicant.
 
Thread starter Similar threads Forum Replies Date
A Some questions about voluntary consensus standards in traditional 510(k) submission US Food and Drug Administration (FDA) 6
A Some doubts about traditional 510(k) submission US Food and Drug Administration (FDA) 5
A Bench test report translation to English for 510(k) submission Other US Medical Device Regulations 2
T First 510(k) submission - Class II software as medical device US Food and Drug Administration (FDA) 4
K 510(K) File eCopy Submission 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 16
P Predicate Device Information for 510(k) Submission Medical Device and FDA Regulations and Standards News 4
D First 510(k) Submission - Don't Forget Tips US Food and Drug Administration (FDA) 5
D Is Human Factors testing mandatory for a 510(k) submission? Human Factors and Ergonomics in Engineering 16
D Pre-Submission after 510(K) Submission? Other US Medical Device Regulations 4
M CBE (Change Being Effected) 510(k) Submission Other US Medical Device Regulations 2
K 510(K) Submission (Traditional) for Medical Device US Food and Drug Administration (FDA) 15
shimonv Referring to previously submitted biocompatibility results in a new 510(k) submission Other US Medical Device Regulations 1
S 510(k) Submission - Orthodontist that wants to distribute aligners in the US ISO 13485:2016 - Medical Device Quality Management Systems 2
shimonv Does 510(k) submission need to include UDI Data Other US Medical Device Regulations 6
D Documentation Requirements for Firmware in a 510(k) Submission Other US Medical Device Regulations 1
D Use of clinical data in a 510(k) submission Other US Medical Device Regulations 6
M 510(K) submission for clinical study devices US Food and Drug Administration (FDA) 2
V 510(K) Cyber Security Documentation for Pre-market Submission (Templates) Other US Medical Device Regulations 6
A FDA 510(k) Submission Timelines US Food and Drug Administration (FDA) 1
M Demonstrating battery safety in 510(K) submission for the FDA Other US Medical Device Regulations 9
S FDA Draft Guidance on HLA Kits 510(k) Submission 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 0
D FDA 510(k) Submission Tests - Posterior Cervical Spinestem 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
Z Agile Software Development and 510(k) Submission 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
T 510(k) Revision Level History and Submission Requirements 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
W 510(k) Submission for a huge, changing complex Medical Device System Other US Medical Device Regulations 6
T Level of Concern for Class II Medical Device Software 510(k) Submission 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
S Revision of 510(k) Submission Documents - Risk Management Report? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
R Who must sign 510(k) Submission? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
A Should I submit the entire copy of my software in a 510(k) submission?? US Food and Drug Administration (FDA) 7
I About the 510(k) Submission US Company but Products are made in China US Food and Drug Administration (FDA) 5
S Clinical or Non-Clinical Data in 510(k) Submission for a type II Medical Device US Food and Drug Administration (FDA) 1
shimonv Bench Testing as part of 510(k) Submission US Food and Drug Administration (FDA) 1
C Locating Approved Special 510(k) Submission Data from 1997 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
I Cost to prepare 510(k) submission (resources, time, dollars) 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
T IEC 62304:2006: Medical device software SDLC- CE Vs. Fda 510(k) submission IEC 62304 - Medical Device Software Life Cycle Processes 16
W Applying for 510(k) Submission for Blood Glucose Monitor System 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
P Blood Glucose Monitor - Sample 510(k) submission application 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
C 510(K) submission - Is it necessary if we changed from nylon to polyester suture? US Food and Drug Administration (FDA) 4
S Does Windows Service Pack (SP-3) upgrade need supplementary 510(k) submission?? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 6
L Software Documents in 510(k) submission (Moderate Level Concern) Other US Medical Device Regulations 1
W 510(k) submission - Questions about page 2 of form 3654 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
T 510(k) Submission for Outsourced Automated Instrumentation System Components 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
T Submission of 510(k) - Does the FDA require a predefined structure of the content? ISO 13485:2016 - Medical Device Quality Management Systems 2
R EC11 - Guidance Document - FDA 510 (k) Submission - ECG Monitors 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 8
D FDA Question: Contents of an FDA 510(k) Submission ISO 13485:2016 - Medical Device Quality Management Systems 1
A 510(k) review timeline 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
L Impact on 510(k) to use an additional manufacture US Food and Drug Administration (FDA) 0
Watchcat Advantages to pursuing a Special 510(k) instead of a Traditional 510(k) Other US Medical Device Regulations 5
A 510(k) registration and listing US Food and Drug Administration (FDA) 1
Aymaneh Traditional 510(k) Declaration of Conformity Other Medical Device Regulations World-Wide 3

Similar threads

Top Bottom