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510(K) Submission (Traditional) for Medical Device

Kuldeep Singh

Involved In Discussions
#1
Hi Everyone,

We are manufacturer of X-Ray Medical device which falls under Class II FDA regulations. We are new to 510(K) submission and almost compile all the necessary data for 510(K) traditional except External lab test reports (like IEC 60601 & IEC 60601-1-2).
As we know it takes almost 180 days for review. So, is there any other way to submit the file without External lab test reports (e.g IEC 60601-1 & IEC 60601-1-2) and once we receive the reports then these shall be submitted to FDA (Actually Testing is already done but labs are unable to proceed for test reports due to their external audits). It is just to avoid the delay in getting 510(K) for our product.

Thanks in advance.
 
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med_cert

Involved In Discussions
#2
Hi,
It depends... if FDA takes your application under "administrative acceptance review" very soon after your submission, then you will be called for additional documents very soon... I am not familiar how long FDA waits for additional documents if they find some of them missing... Based on my experiences, FDA usually starts this review within few days and if they find anything missing, they give you very short time to react for "Interactive reivew"... maybe you could avoid "interactive review", in that case they will prolong the due date for missing document. In each case I believe you will not benefit... I suggest you to wait for those test reports.

I would suggest you to submit the documents if some not-so-important info would be missing, that would be pointed out later in the review process...
 

med_cert

Involved In Discussions
#4
OK, I did not mention that we are not "X-Ray Medical device" manufacturer, however we also manufacture Class II medical device and we have to submit the reports. Then it's different for X-Ray imaging devices...
 

Kuldeep Singh

Involved In Discussions
#5
According to the attached, you don't need to submit the reports.
Thanks for your reply

Would you please specify where it is mention that Test reports were not mandatory for 510(K) traditional in that document .It will help us to collect the evidences to show my boss for favour of 510(K) submission without test reports.
 

Al Rosen

Staff member
Super Moderator
#6
Thanks for your reply

Would you please specify where it is mention that Test reports were not mandatory for 510(K) traditional in that document .It will help us to collect the evidences to show my boss for favour of 510(K) submission without test reports.
Look at sections 5 & 6.
 

Kuldeep Singh

Involved In Discussions
#7
Hi,

There is one more doubt in my mind for FORM 3654 " STANDARDS DATA REPORT FOR 510(K) " . For Special 510(K) is it mandatory to be provided within 510(K) special submission ?

If yes please provide the status of that format. Because the current status of that format is not cleared whether it is obsolete or not.
 

Kuldeep Singh

Involved In Discussions
#9
Thanks Ronen E

What I understand from the Thread you shared with us,is Form 3654 is no longer needed. So that mean we have to remove this Form 3654 from our 510(K) special / Traditional table of content.

Is there any new document added in replace of this form?
 

Ronen E

Problem Solver
Staff member
Moderator
#10
Thanks Ronen E

What I understand from the Thread you shared with us,is Form 3654 is no longer needed. So that mean we have to remove this Form 3654 from our 510(K) special / Traditional table of content.

Is there any new document added in replace of this form?
All the answers you need are in the link I posted in that other thread.
 
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