FDA Submission Printing Format - Is double sided printing allowed?

M

murena

#1
Hi, I have a simple question.

Is it allowed to file a medical device submission (PMA, PMA Supplement or 510(k)) with the documents printed double sided?

Traditionally we print one side, because appartently that is what FDA expects, but I have not been able to locate the specific requirement in any FDA document.

What is your experience?

Thanks
 
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G

Gert Sorensen

#2
The issue is not whether it is allowed, the issue is whether it is the best way to present your documents, and the most convenient way for the FDA-employee to browse through your documentation. What you save in printing-costs may become an expense in other regards.

:bigwave:
 
M

murena

#3
Thanks Gert, my motivation was more from the environmental point of view. Nevertheless, I see your point and wouldn't want to add difficulty for the review of our submissions.
 
I

isoalchemist

#4
Don't forget the FDA is allowing some electronic submission for these items with one hard copy and the rest being electronic. They allow (or propose to allow) differences that would permit a paper copy pointer to electronic data for large data sets. The recently put out a draft guidance "eCopy Program for Medical Device Submissions" for comment in mid-October.

Slowly moving green, but based more on process flow than environmental concerns, based on whta I heard at the last FDA seminar.
 
N

Naoual

#5
Hello,
I have some questions about the eCopy submission, if some one have the same, please let me know:

To complete the review of special 510(k) file of orthopedic implant, I
> should submit to the FDA the response by paper copies and eCopy.
>
> I download the eCopy software and register my pdf file on CDRH: eCopies.
> After packaging submission files and at the step n?3 I have not had
> the submittal letter !!
>
> I saw a video on the FDA website Launching and Navigating the
> eSubmitter Interface and in one slide, there is a comment saying
> please note the submittal letter is only applicable to certain
> submission types within CDRH
>
>
> therefore, the submittal letter is it required for the eCopies?
> If yes, how can I proceed to get it?
>
>
> Thank you for your responses
 
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