ARTICLE SUMMARY:
Laboratory groups have been meeting with FDA and other government officials all month to register discontent with the agency’s imminent plan for proposed regulations to oversee laboratory-developed test services.
FDA is getting an earful from lab groups in the lead-up to the agency’s planned release of a proposed rule to set up a new regulatory framework for laboratory developed tests (LDTs). Their underlying message to the agency: abort.
Ever since Congress failed to pass legislation last year that would have revamped FDA’s oversight of lab diagnostics, the agency has made it clear that it is moving ahead with regulations to bring LDTs more directly into its regulatory fold.
