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. (Also see "Pre-Certs, Test Groups And More: US FDA...