Advice for first time renewing Variances

[jgoodwin27]

Hey guys,

So my thoughts are starting to get turned towards when I will have to renew my variance for my lasers - being the first time I have ever done this I am somewhat nervous of making sure I have all the correct information displayed how and where it should be. I am wondering if you guys have any guidelines, suggestions, advice, things to watch for, things to make sure to put, ect ect. Basically any words will be nice to take some of the nerves and fear out.

Thanks for the help!

[VJ AIWAZ]

renewals are automatically processed when you submit your annual report due before September 1st

http://www.fda.gov/downloads/AboutFD.../UCM081603.pdf

[jgoodwin27]

Is this the only form that needs to be turned in during an annual report, I thought there was stuff about show specifics (start times, stop times, diagrams of setup, ect ect) that needed to be turned in as well.

Sorry if these questions seem very basic, like I said this is my first year creating one of these reports and I would like to make sure to have it all correct the first time.

[VJ AIWAZ]

well yes and no you need those record in case requested by the cdrh(inspection or other reason) but not for the annual

[Bradfo69]

Pretty much what he said. The annual report is pretty simple and really may only be two pages. Yes, it's also a very good practice, even if you no longer have to file them, to write up a show report. I don't always get to them immediately but, I have enough records to be able to still get them completed. Granted most of my shows are exactly the same so often it's just changing the clients name and the date but, I do maintain the records.

[jgoodwin27]

ah, thats a breath of fresh air then. I had all these numbers and notes on shows and things and I was scared how best to organize and produce it. That makes it super easy if it is just that form real fast and thats it (until you get inspected of course).

I appreciate your help.