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Clinical Labs Find Fault In FDA Dx Reform Ideas, But Kit-Makers Signal General Approval

 
• By Sue Darcey

The American Clinical Laboratory Association (ACLA) split with other stakeholder groups in criticizing US FDA’s proposals for a new diagnostics regulatory regime. ACLA asked Congress to stay closer to Reps. Diana DeGette's and Larry Bucshon’s original Diagnostics Accuracy and Innovation Act draft bill language.

test tube

Makers of test kits, represented by AdvaMedDx, and at least two health research groups this week spoke in favor of US FDA’s newly recommended approach to regulating in vitro clinical tests, but laboratories, represented by ACLA, questioned the agency’s suggested changes to the Diagnostics Accuracy and Innovation Act, a key diagnostics reform bill.

FDA submitted its recommendations on the DAIA discussion draft to Congress earlier this month in a technical assessment (TA) document....

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