US REFERENCE LABS are being challenged by the FDA for possible new regulation, and the American Clinical Lab Association has filed a Citizen’s Petition disputing that the FDA has the authority to regulate them, because by definition they are not ‘devices’ over which the FDA does has legislative authority. The existing approval for reference labs is under the Clinical Labs Improvement Act or CLIA, and has resulted in a safe and orderly industry for many decades. How about a real problem target like the food industry. Did I mention tobacco?
linkedin post 2022-06-29 05:12:48
Nigel Fleming
September 21, 2022