AM25-TU-13-L - 2025 Ask the FDA and CMS/CLIA

Tuesday, October 28, 2025

9:30 AM - 11:00 AM PT

Room: SDCC 20BC

CE: 1.5 CME (AMA Physician Credit) / 1.5 CE (Non-Physician Credit)

Program Chair(s)

Karen E. Palmer, MT(ASCP), CQA(ASQ)

Director, Regulatory Affairs
AABB
Bethesda, Maryland

Disclosure(s): No financial relationships to disclose

Handouts

Speaker(s)

Anne F. Eder, MD PhD

Director
Office of Blood Research and Review (OBRR), CBER, FDA
Silver Spring, Maryland

Disclosure information not submitted.

Handouts
O

Orieji Illoh, MD, CBER, OBRR

Disclosure(s): No financial relationships to disclose

This popular session consistently draws a large audience and provides an opportunity for the regulatory experts with the Food and Drug Administration (FDA) and the Centers for Medicare & Medicaid Services/Clinical Laboratory Improvement Amendments representatives to respond to member questions about new rules, regulations and guidance. The session also gives FDA an opportunity to present their current thinking on policies, regulations, guidance documents and inspection programs that are relevant to their oversight of blood and human cells, tissues and tissue-based products (HCT/P) programs. Questions for the session are submitted in advance to regulatory@aabb.org.

Learning Objectives:

Evaluate existing blood center and transfusion service practices to establish alignment with current regulatory requirements and recommendations.
Understand FDA's recommendations in recently issued guidance to industry.
Describe FDA and CMS requirements for blood and HCT/P policies, regulations and inspection programs.