The Meaning Of 'Accurate': Debate Continues With Latest CLIA Waiver Guidances
Executive Summary
Accuracy "is a widely used and generally understood term in clinical laboratory sciences," according to US FDA, but industry groups say the agency continues to misunderstand Congress' use of the word when it comes to CLIA waivers for point-of-care tests, including in a draft guidance document issued by the agency in recent days. FDA is also touting a new, more efficient approach to dual 510(k)-CLIA waiver submissions.