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510(K) File eCopy Submission

Kuldeep Singh

Involved In Discussions
#1
Hi Everyone,

We would like to introduce ourselves as Manufacturer of Medical Diagnostic Equipment's namely X-Ray Machines falls under Class II product of FDA regulation. We prepared a 510(K) file for our High Frequency C-Arm machine. As I read the ecopy FDA guidance document and conclude that we have to submit a pdf equal to or less than 50MB and we arrange the document accordingly. But still i have below questions in my mind

1. For 510(K) file submission , total 4 pdf files were prepared under 50MB . So can we submit all these 4 pdf files in single CD/DVD or multiple CD/DVD have to submit for single pdf in it?
2. As i discussed above total 4 pdf files were prepared , So we have to submit Hard copy accordingly ? that means in File 1 (Hard copy) contains the data according to PDF 1 and so on? if we arrange all the data in hard, it can manage in two files only.
 

primavesvera

Involved In Discussions
#2
Hi Everyone,

We would like to introduce ourselves as Manufacturer of Medical Diagnostic Equipment's namely X-Ray Machines falls under Class II product of FDA regulation. We prepared a 510(K) file for our High Frequency C-Arm machine. As I read the ecopy FDA guidance document and conclude that we have to submit a pdf equal to or less than 50MB and we arrange the document accordingly. But still i have below questions in my mind

1. For 510(K) file submission , total 4 pdf files were prepared under 50MB . So can we submit all these 4 pdf files in single CD/DVD or multiple CD/DVD have to submit for single pdf in it?
2. As i discussed above total 4 pdf files were prepared , So we have to submit Hard copy accordingly ? that means in File 1 (Hard copy) contains the data according to PDF 1 and so on? if we arrange all the data in hard, it can manage in two files only.
You submit on one CD/DVD. The rule is that an individual pdf file cannot exceed 50MB: https://www.fda.gov/media/83522/download pg. 23
And, as for the hard copy, you don't have to: https://s3.amazonaws.com/public-inspection.federalregister.gov/2019-27047.pdf

I hope this helps.
 

akp060

Starting to get Involved
#3
Yes you can submit them in a single media.

Hard copy- You submit only one file with the print out of all 4pdfs.

Just wondering, Only 4 pdf files for an X-ray machine, you must have done some serious consolidation. Is it a special 510(k), let me know only if you do not have a conflict of Interest with your organization.
 

Ronen E

Problem Solver
Staff member
Super Moderator
#4
@Kuldeep Singh
Since no hard copy is required anymore (as of Dec 2019), eSubmitter/ESG can do the entire job for you. You can package multiple files in a format that is most convenient for CDRH.

Make sure that you use the latest eCopy and RTA guidances, as they were updated when the hard copy requirement was dropped.

I hope you also observed 21 CFR subchapter J - Radiological Health.
 

Kuldeep Singh

Involved In Discussions
#5

primavesvera

Involved In Discussions
#6
Thanks for your Guidance

Here I read about the signed cover letter requirement along with e-Copy of 510(k) file in Guidance document for e-Copy submission https://www.fda.gov/media/83522/download .

Can anyone guide us, Is it the same cover letter as define in 510(k) Contents : https://www.fda.gov/medical-devices/premarket-notification-510k/content-510k and which we introduce in our 510(k) file.

or it is another requirement. If yes, would anyone help us by sharing the template for same.
You don't need to create another cover letter just because you are sending eCopy. Just do the regular one you already planned for the 510(k).
 
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