back to the future, page-2

Yes, you are correct gmutton. I still have a few old clippings re Optiscan from years gone by. One in November, 2000 when an article mentions:

"General manager Roger Wallis says Optiscan is hopeful that it will be exempt from the lengthy approval process that applies for pharmaceutical products. 'This is really a tool for the clinician. It is not invasive; we are not making great claims about its capabilities; there are not the same safety issues as with a drug or a treatment"

This is followed up in May 200l with a company ASX announcement where : "Optiscan Imaging Limited is pleased to report that a response has been received from the American Food and Drug Administration (FDA) in relation to the company's 'STRATUM' microscope. As anticipated by the company, the Stratum falls into regulatory Class l and is an exempt medical device. The FDA has found the Stratum to be exempt from the pre-market notification requirements of the United States Federal Food, Drug and Cosmetic Act".

Does this mean that the current requirements for CE approval and FDA approval would be similar to the STRATUM of 17 years ago - not being a drug or a treatment and therefore a straightforward and a prompt response application ?

MM