0      0

AM23-ST-19-O - AM23-ST-19-O: Ask the FDA and CMS/CLIA (Enduring)

Expiration Date: Dec 31, 2025

Credits: None available.

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 allows the FDA to present their current thinking on policies, regulations, guidance documents, and inspection programs 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




  • Karen Palmer, MT(ASCP) CQA(ASQ):
    No financial relationships to disclose

All relevant financial relationships have been mitigated.

By completing the evaluation, you are attesting to watching the presentation in its entirety. A certificate will be immediately provided after submission.

Credits Available

AM23-ST-19-O: Ask the FDA and CMS/CLIA (Enduring) Evaluation