SBS - The best value in QMS software

Redacted 510(k)s - Example wanted

Dobby1979

Involved In Discussions
#1
Hi All.

Does anyone have a redacted (not to the FDA level) submission that they would be willing to share? I am moving closer to my first submission and I would like to compare against something to see if I am adding too much or too little detail!

I appreciate that all submissions are different but if anybody has anything, it would be a great help.

Please feel free to private message rather than post on here if you can help at all.

Thanks
 
Elsmar Forum Sponsor

Dobby1979

Involved In Discussions
#3
Hi Al.

Thanks for the link but the redacted 510k's listed on the FDA are too.......redacted! Obviously a big a ask but was hoping that someone might a submission that they could share privatley so I could compare, make sure I had not missed anything major and had the right level of detail etc.
 

Al Rosen

Staff member
Super Moderator
#4
Hi Al.

Thanks for the link but the redacted 510k's listed on the FDA are too.......redacted! Obviously a big a ask but was hoping that someone might a submission that they could share privatley so I could compare, make sure I had not missed anything major and had the right level of detail etc.
It's unlikely someone would share that.
 

Al Rosen

Staff member
Super Moderator
#7
Hi Dobby,

you can contact me via email or my website. I can´t give you an example, but maybe there´s another way that could help.

Kind regards
thinqbetter
What is another way? Rather than keeping it private, please explain it in the thread so others are helped as well. We're here to share, not sell.
 

Dobby1979

Involved In Discussions
#9
I think you have misunderstood me saying ‘generous’ as meaning I am asking for someone to sell me this! I was meaning in a light hearted way that someone might be willing to share a redacted a file that they had.
I have my 20 (well 21actually) but I don’t know if I have included enough detail or not formatted in a correct way. We are a small company and don’t have the money to involve consultants, yet we want to try and ensure the submission goes as smoothly as possible. I just thought someone might have a redacted submission that gave enough detail to be useful as the ones on the FDA website do not really help in my opinion.
 

Ronen E

Problem Solver
Staff member
Moderator
#10
I think you have misunderstood me saying ‘generous’ as meaning I am asking for someone to sell me this! I was meaning in a light hearted way that someone might be willing to share a redacted a file that they had.
I have my 20 (well 21actually) but I don’t know if I have included enough detail or not formatted in a correct way. We are a small company and don’t have the money to involve consultants, yet we want to try and ensure the submission goes as smoothly as possible. I just thought someone might have a redacted submission that gave enough detail to be useful as the ones on the FDA website do not really help in my opinion.
Yup, unicorns abound.
Sorry, scratch that.
We're here to share, not sell.
Al,

I'm here to share and help (and the record would prove that), but there's only a fine line between "generous" sharing and rude abuse of good will. If I (or anyone) have put in a lot of time and work into preparing something (not to mention years of learning things the hard way), I don't necessarily want to give it away as a freebie but I might be open to negotiating a fair compensation for my efforts, should anyone be interested. The fact that someone didn't plan or budget properly and "doesn't have money" is not particularly moving as far as I'm concerned. Sorry if that's too harsh on anyone.

To me the key word is "fair".
 
Last edited:
Thread starter Similar threads Forum Replies Date
D Redacted pre-submission bundle that you would be willing to share US Food and Drug Administration (FDA) 3
S Predicate Material 510(k) US Food and Drug Administration (FDA) 0
S Predicate Material 510(k) Medical Device and FDA Regulations and Standards News 3
J US Device Listing when not the 510(k) owner Medical Device and FDA Regulations and Standards News 2
supadrai Possible to Submit a 510(k) if you have never, do not and cannot produce the device for which you're submitting the application? US Food and Drug Administration (FDA) 4
S Special 510(k) for orthopedic implant 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
M Label change - 510(k) Medical Device and FDA Regulations and Standards News 5
G We want to add Covid-2 /19 to our air filter 510 K Medical Device and FDA Regulations and Standards News 0
A The refund of 510(k) user fee Medical Device and FDA Regulations and Standards News 0
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
A 510(k) review timeline 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
L Impact on 510(k) to use an additional manufacture US Food and Drug Administration (FDA) 0
T 510(k) submission - Which name should I use in the submission? Other US Medical Device Regulations 3
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
M Should 510(k) Predicates be Actively Listed Devices? Other US Medical Device Regulations 12
A Several sections of traditional 510(K) have the same or similar requirement of content. US Food and Drug Administration (FDA) 4
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
S Special 510(K) - Labeling change from Rx to OTC Other US Medical Device Regulations 11
J 510(k) for a control kit for an external IVD test kit 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
Y Expanding the indications for use for a 510(k) cleared device Medical Device and FDA Regulations and Standards News 5
T First 510(k) submission - Class II software as medical device US Food and Drug Administration (FDA) 4
T Submitting MR Compatibility Data for 510(k) Cleared Device Other Medical Device and Orthopedic Related Topics 2
M CE Mark and 510(k) -Global registration requirements for every country Other Medical Device Regulations World-Wide 3
Z 510(k) usage - Company has 2 physically similar products Medical Device and FDA Regulations and Standards News 2
K 510(K) File eCopy Submission 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 16
Q Need clarification on requirements.... Class i, gmp & 510(k) exempt Medical Device and FDA Regulations and Standards News 12
K Changing the Address in 510(K) Approved Product 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
K Completing Design Controls after 510(k) Clearance Other US Medical Device Regulations 11
P Predicate Device Information for 510(k) Submission Medical Device and FDA Regulations and Standards News 4
M 510(k) 10993 Biocompability Testing Other US Medical Device Regulations 15
D First 510(k) Submission - Don't Forget Tips US Food and Drug Administration (FDA) 5
K Reporting a Change of Contract Manufacturer for a 510(k) cleared device Other US Medical Device Regulations 5
K Mammography Machine Bench Testing - FDA 510(K) 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 Informational US FDA Final Guidance – Special Premarket Notification [510(k)] Pathway Medical Device and FDA Regulations and Standards News 0
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
F Replacement Bone Screws - Traditional 510(k) or Special 510(k)? Other US Medical Device Regulations 7
M Informational US FDA Final guidance – Metal Expandable Biliary Stents – Premarket Notification (510(k)) Submissions Medical Device and FDA Regulations and Standards News 0
Watchcat Informational FDA Proposal to "Modernize" the 510(k) - 2019 Other US Medical Device Regulations 1
B 510(k) clearance claim on medical device product packaging Other US Medical Device Regulations 6
shimonv Referring to previously submitted biocompatibility results in a new 510(k) submission Other US Medical Device Regulations 1
L A Taiwan company want to sell Class I medical device (510(k) exempt) on Amazon, should we register with FDA? US Food and Drug Administration (FDA) 4
B Submit a 510(k) with a Predicate cleared but not Listed US Food and Drug Administration (FDA) 9
R 510(k) Biocompatibility vs Cleaning Validation Other Medical Device Related Standards 4

Similar threads

Top Bottom