CLIA Waiver for IVD Medical Devices

I didn't understand until recently why in vitro diagnostic device companies had to worry about CLIA waiver. CLIA, the Clinical Laboratory Improvement Act, is a certification for clinical laboratories. An individual laboratory is certified according to the complexity of in vitro diagnostic test they are qualified to run. The idea is that laboratories who have the best trained technicians, experienced PhDs as laboratory directors, and the most modern equipment are the laboratories that perform the most complex of diagnostic tests; laboratories with lesser trained technicians and less equipment perform the simplist of IVD tests. But I always considered it to be a laboratory issue, not a medical device manufacturer's issue.

Then comes the new FDA guidance "Recommendations for Clinical Laboratory Improvement Amendments of 1988 (CLIA) Waiver Applications for Manufacturers of In Vitro Diagnostic Devices" 30 Jan 08, http://www.fda.gov/cdrh/oivd/guidance/1171.html#1, and suddenly a light-bulb comes on. Of course a manufacturer of IVD devices wants their product to be 'waived' because it means they can offer the device for sale to more laboratories. The marketplace increases as the level of complexity category decreases.

I got so excited I asked Dr. Gail Radcliffe to give a virtual e conference on the topic on 11 June. Learn more....