SBS - The Best Value in QMS software

510(k) Revision Level History and Submission Requirements

tebusse

Involved In Discussions
#1
Greetings,

For the 510(k) submission of medical device software, the guidance documentation states that the revision level history generated during the course of product development should be submitted.

This is simple to understand, however, our device is moving from a Class I to a Class II, so the revision level history will actually have been released product.

Should this be explained in this section of the 510(k) that the revision history, up until the latest version, was for the Class I device?

Or, am I opening up a can of worms for the FDA?
 
Elsmar Forum Sponsor
#2
Re: 510(k) Revision Level History

This is not making sense.

I was guessing you hadn't yet submitted this 510 (k).

However, you have released product, so this cannot be so.

How can you just change the classification of a device? The reclassification would mean the SE device and any other SE devices would have to be reclassified as well.
 

tebusse

Involved In Discussions
#3
Re: 510(k) Revision Level History

The device is having a feature added to it that will take it from a Class I to a Class II device. Obviously, we have yet to add this particular feature until the 510(k) is submitted and approved.

I'm guessing the revision level history for the Class I device won't apply.
 
#4
Re: 510(k) Revision Level History

I think I understand.

If this is a new 510 (k) that hasn't been submitted, the design history documentation is sufficient

However, if you are waiting for a 510 (k) approval, you can't reclassify the device, you would need a new 510 (k)
 

sreenu927

Quite Involved in Discussions
#5
Hi,
If I understand correctly,
You have a Class I medical device 'A' listed with US FDA.
Now you are adding some features to 'A' to make it as 'B', which is a Class II medical device.

If this is the case, what is the SW version that you are releasing with B?
In your 510(k) submission file, you need to mention, the SW revision history (version with it's release date) and follow the order until the current SW version for B.

Once you obtain the 510(k) clearance, do you intend to do a field upgrade of A to B or sell B as a separate device? If field upgrade, need to work with FDA on seeking acceptance from FDA.

Regards,
Sreenu
 
Thread starter Similar threads Forum Replies Date
S Revision of 510(k) Submission Documents - Risk Management Report? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
V 510 k submission RTA (Acceptance Checklist ) Other US Medical Device Regulations 5
Watchcat 510(k)s and "Innovation"? Other US Medical Device Regulations 2
D Change to labelling - does it require a new 510(k)? US Food and Drug Administration (FDA) 5
A How can we change a device trade name in 510(k) summary? US Food and Drug Administration (FDA) 0
K PMA vs 510(k) for Mammography Machine US Food and Drug Administration (FDA) 2
S Predicate Material 510(k) US Food and Drug Administration (FDA) 1
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 4
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
D Redacted 510(k)s - Example wanted Document Control Systems, Procedures, Forms and Templates 17
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) 17
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

Similar threads

Top Bottom