The slide presentation from the 2021 AABB Virtual Annual Meeting session “Ask the FDA and CLIA/CMS” is now available with responses from each agency’s representatives included in the slides. Every year, AABB members submit questions for the Food and Drug Administration and Centers for Medicare and Medicaid Services (CMS) representatives to address during this popular AABB Annual Meeting session. In 2021, AABB presented 58 questions to solicit federal regulators’ current thinking on a wide range of topics. AABB encourages members to treat the session slides as a resource as they review their organizations’ current policies and procedures. Members with questions may contact regulatory@aabb.org.