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Biotech / Medical : ACMI - Accumed Inc. -- Ignore unavailable to you. Want to Upgrade?

To: Frank Buck who wrote (923)	1/5/1998 9:50:00 AM
From: Sigmund	Read Replies (1) \| Respond to of 1894

Yes and part of my question on this is that it seems that the reviewer can drop it back in the company's lap if the reviewer doesn't want to use this process. Is this correct and if so does the company have reason to believe that this process will fly for this product i.e. word from the FDA? Is part of the answer that this product is relatively non-controversial? The cytotechs seem to be highly organized and able to defend their jobs. But perhaps this product does not arouse the impacted techs in the same way. Is that really the difference? This seems to be a great product so we wouldn't want a surprise re the approval process!!

To: Frank Buck who wrote (923)	1/5/1998 3:20:00 PM
From: Dana Winrow	Read Replies (2) \| Respond to of 1894

Topic: The 510(k) process Frank, you summed it up rather nicely. To restate and expand upon your explanation: The 510(k) clearance process proves substantial equivalence to an already-existing (predicate) device that has been cleared for marketing application by the FDA. The company who markets the predicate device has already proven to the FDA that its product demonstrates safety and effectiveness. This process may or may not require clinical studies. The PMA approval system proves to the FDA that the product is safe and effective. Normally, there are no predicate devices. This process requires clinical studies for supporting documentation of safety and effectiveness. It is my understanding that the FDA ultimately determines which process a company must undertake prior to marketing its new device. Dana Winrow Director, Investor Relations AccuMed International, Inc.