View Full Version : CDRH Annual report

08-30-2009, 16:58
I know it's due on Monday but I can't find the right link for the form. This would be the laser show annual report. Can anyone help me with the right link. :confused:

Thank you,

James :D

Laser Ben
08-30-2009, 20:20
Additionally, I got this from the Laserist List today:

Hi everyone,
Before you mail your annual report, check to make sure you have the right address. I asked Dan Hewett (my normal contact at the CDRH) and following is what he sent me:
U.S. Food and Drug Administration
Center for Devices and Radiological Heath
Document Mail Center WO66-G609
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002

This is different than where it went last year.

08-30-2009, 20:47
Any chance you know the right form to send in? This is my first year doing this. :) I thought I had the right one be Johnathon told me I filled out the wrong one.

08-31-2009, 02:57
ANNUAL REPORTS (http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM119252.pdf)

This is what i filed out this year and the past 4 years. Never had a problem.


08-31-2009, 09:37
Thank you everyone! Just in time.:)