Bass, Berry & Sims attorneys Clint Hermes and Heather Pearson authored a “Human Cell and Tissue Laboratory Establishment Checklist” for LexisNexis that outlines key regulatory considerations for those looking to establish a laboratory that grows or uses human cells and tissues for implantation, transplantation, infusion, or transfer into a patient. The checklist describes regulatory issues faced by entities establishing laboratories and how the U.S. Food and Drug Administration (FDA) expects them to address these issues.

The attorneys examine the following topics in the checklist:

  • Preregistration and prelisting considerations
  • Registration and listing
  • Registration procedure
  • Post-registration and listing

The full checklist is available on the Lexis platform here.