Electronic 510(K) Submissions

A

AliceW

#1
Are electronic 510(K) submissions gaining ground - should we be putting a system in place now or is it still too early. Don't want to be an early adopter and suffer from lack of a clear process. Does anyone have a feel for how long it will be before electronic submissions are mandatory for devices?

Many thanks

Alice
 
Elsmar Forum Sponsor
G

GPjeri

#2
I would not waste time and money on trying FDAs systems. Our reviewers have discouraged us from using esub; been told sure we can use it but they will still ask for full paper copies. Supposedly, FDA is working on a new system, RPS, but their guru left (for Microsoft) so they are about 2 years behind. We submit hard copy, and provide CD's or DVD's that are elinked to expedite review. Still, not an easy task to create your own publishing process but doable, and does pay off when the questions come in.
 
S

singber

#3
We do the same as the previous post - paper copies and a CD/DVD that is an exact copy of the paper submission. The CD/DVD contains links to all sections and helps to speed up review. Just make sure you review the CD/DVD thoroughly and confirm that all links function and take you to the correct place within the documents.
 
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