Post your variance, produce report, and show report questions here

[Mlenox]

Does anyone know of a way to find out the status of a variance application? We submitted almost a year ago, with no reply yet...

[hitekvoop]

Sorta. They're public records, so if your variance, like mine, was silently approved and you never received a letter saying so, you can look up the status based on your docket #. You should've received one or two responses from FDA early on (10-15 days after submittal) stating that your application was received and containing a docket number. If the docket # looks like 2014-V-xxxx then that would become your variance # once the app is approved.

Try googling: FDA-<your docket # here>

You should see at least something get kicked back... Good luck!

[hakzaw1]

THANX Rick nice to know that..
subbing

[hakzaw1]

I think these questions are more aimed at manufacturers who are going to be making more than one. The CDRH wants to know how the manufacturer has designed their sourcing, manufacturing, testing, QC and change control processes so that every unit produced is compliant. You'll be making your case as to why these regulations do not apply to your projector in your product variance (which you can submit at the same time as your product report).

Also, the FDA has a program for electronic submission of your product report and variance, your laser show report and variance AND your show reports:

http://www.fda.gov/downloads/ForIndu.../UCM162419.pdf

^^^^THIS post is quite old and ATM does not work..

anybody got a good link?

OOPS
MY BAD
it works-had to reload twice-thanx robin

[gottaluvlasers]

Regulations.gov is what they are trying to keep up to date. It is probably about 70% accurate. If you submitted a year ago, you should see some sort of results on that site.