Search the Elsmar Cove!
**Search ALL of Elsmar.com** with DuckDuckGo including content not in the forum - Search results with No ads.

Previewing changes to revised Standards

S

s.parakos

#1
Hi,

We recently submitted our 510(k) application.
It included a Sterilization Validation report and other documents created a number of years ago and some of the standards referenced are now out of date.
The FDA has asked we provide information as to whether the documents are still valid.

What I would like to know is if there is a listing somewhere of changes that have been made between different versions of standards.

I will purchase the new versions and read them all if I have to (quite a number) but I was hoping there may be a quicker alternative, particularly if the changes are minor or not related to our actual documents.

Simon
 

sagai

Quite Involved in Discussions
#2
Re: Preview changes to Standards

It is difficult if not impossible to prove for regulatory purposes how did you reach any conclusion about the standard when you do not even have it.
Cheers!
 
S

s.parakos

#3
Re: Preview changes to Standards

I have copies of all the Standards that applied at the time.
I was hoping the Standards organisations may provide notifications of what updates to those standards entail. I haven't been able to find this info though.
 
Top Bottom