I posted this link about a year ago and realized that the link is no longer valid.
I updated some of the forms here. but here is a link to FDA/CDRH forms and info for USA Laserists.
I tried to get it all in ONE location, seeing that the CDRH LOOOOVES to make things IMPOSSIBLE for us to try and comply with their rules and regs.
FDA / CDRH FORMS AND INFORMATION. DOWNLOAD HERE.
click here to look up Companies' Variance info. Submitted reports. And any possible warning letters or compliance issues related to a company.
Click Here for a complete list of forms related to Radiological Health. (including Lasers).
Can we try to Sticky this post or something??
-Marc