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Biotech / Medical : Trinity Biotech (TRIBY) -- Ignore unavailable to you. Want to Upgrade?

To: EagleC who wrote (9915)	7/28/1998 3:14:00 PM
From: Keiko	Read Replies (3) \| Respond to of 14328

Mark, The US FDA has quite different approval processing for all medical devices, test kits, pharmaceuticals, orthopedic devices, heart medications, cardiac pacemakers etc. The FDA breaks these down into several subgroups including 510(k) PMA ....IDE etc Generally , medical devices including test kits are submitted under 510(k). Since they are not used in vivo (inside the body ) the approval time is relatively short and not quite as expensive as a PMA (pre market approval) The Strep screening test would be filed under a 510(k) and not require the exhaustive field trials as say approval for Viagra , Redux or Rezulin which runs into several million dollars. The Unigold HIV test was submitted as a PMA.....very time consuming and quite expensive to conduct trials because of the grim morbidity of contracting this grave disease, AIDS &&&......Keiko