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Biotech / Medical : ACMI - Accumed Inc.
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To: Frank Buck who wrote (923)1/5/1998 3:20:00 PM
From: Dana Winrow  Read Replies (2) 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.
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