Change of Existing Medical Devices and 510(k)

Kuldeep Singh

Involved In Discussions
#1
Hi

We are manufacturer of Medical X-Ray equipment and already approved by FDA for our one of product. We want to know about the changes for which 510(K) re-submission is required. for example , If we are adding any alternate model of X-Ray tube and Flat panel detector (Image capturing device) in our existing 510(K) product, then we have to submit another 510(K) or not? Although these changes doesn't affect the intended use, safety or effectiveness and performance of device.

If there is requirement for inform to fda for these changes, then what is the procedure for inform to FDA for these changes and if there is no requirement to inform about these changes, then how would be reflect these changes in our Existing 510(K).

Thanks in advance for your suggestions.
 

Ronen E

Problem Solver
Staff member
Super Moderator
#2
https :// www .fda.gov/ucm/groups/fdagov-public/fdagov-meddev-gen/documents/document/ucm514771.pdf - BROKEN LINK UNLINKED

Also search Elsmar for "letter to file", "add to file" or "note to file"
 
Last edited by a moderator:

Kuldeep Singh

Involved In Discussions
#3
Thanks for sharing the document. As per guidance document attached by you, we decided to inform to FDA for changes. Then what will be the procedure to submit a new 510(K) for existing one . As i didn't find any guidance about to inform the FDA for changes. Please suggest for steps

Would we have to submit a new 510 (K) (approx 23 sections as we previously submitted during its last submission ) or submission of documents in which changes reflect, is sufficient for new submission of 510(K).
 

Kuldeep Singh

Involved In Discussions
#5
We are preparing all the documents as per 510(K). What should i do? Resubmitting the file like i previously submit (Such as submission fees etc ) for the same device. I think for minor changes in existing 510(K) there should be provision or negotiation in fees or other things. Changes in Medical devices are so common in order to meet State of art technology.
 

Ronen E

Problem Solver
Staff member
Super Moderator
#6
We are preparing all the documents as per 510(K). What should i do? Resubmitting the file like i previously submit (Such as submission fees etc ) for the same device. I think for minor changes in existing 510(K) there should be provision or negotiation in fees or other things. Changes in Medical devices are so common in order to meet State of art technology.
Not all changes require resubmitting. However, where resubmission is required the fee is uniform and non-negotiable regardless of the "magnitude" of the change (AFAIK).
FDA provide detailed guidance regarding submission procedures and fees, it's all available online. As part of that you should observe the RTA (refuse to accept) guidance.
 

Kuldeep Singh

Involved In Discussions
#9
Continuing the above threads!

We are deciding to submit 510(K) special and all the sufficient data for submission is collected/prepared.

Still we have doubt for below queries:-
1. Our X-Ray Medical Device utilize a software (purchased by third party) and now we are going to replace it with self developed and all the documentation according to moderate level of concern is prepared.
I am reading about 510(K) special , there mention all about modification in existing component or software.
- In our case , where a new software is added ,then what should we do? Submit Special 510(K) or Traditional 510(K) ?

2. In 510(K) special table of content , there mentioned a term Certificate of compliance (COC) from clinicaltrail.gov ?
For us (Medical X-Ray equipment manufacturers) what will you suggest ? We should go for that COC?
although we perform bench testing by using phantoms to show equivalence with already 510(K) cleared devices. Is it sufficient to avoid Clinical data?

Thanks in advance
 

Ronen E

Problem Solver
Staff member
Super Moderator
#10
In our case , where a new software is added ,then what should we do? Submit Special 510(K) or Traditional 510(K) ?
You should consider the device as a whole. If the device is more than just the software, replacing the software would be a device change IMO, so it would be a Special 510k.
2. In 510(K) special table of content , there mentioned a term Certificate of compliance (COC) from clinicaltrail.gov ?
For us (Medical X-Ray equipment manufacturers) what will you suggest ? We should go for that COC?
although we perform bench testing by using phantoms to show equivalence with already 510(K) cleared devices. Is it sufficient to avoid Clinical data?
See the FDA guidance entitled "Form FDA 3674 - Certifications To Accompany Drug, Biological Product, and Device Applications/Submissions" for additional information. According to this guidance, 510(k) submissions that do not contain clinical data do not need the certification form.
Normally 510k submissions do not require clinical data.
 

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