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FDA Update on Cord Blood Banking Regulations

ISCT 6th Annual Somatic Cell Therapy Symposium
9/25-27/2006

Ellen Lazarus, M.D.
Division of Human Tissues
Office of Cellular, Tissue, and Gene Therapies

Cord blood for family-related use

  • Regulated solely under set of HCT/P final rules with associated (draft) guidance, unless more than minimally manipulated or for non-homologous use or combined with another article (with some exceptions)
  • Registration and listing
  • Compliance with cGTPs, including donor eligibility regulations, assessed at inspection
  • "Cross-over" (cord blood for family-related use converted to unrelated donor inventory) - no mechanism at this time

Cord blood from unrelated donors

  • Regulated as HCT/P under 21 CFR Part 1271 Subparts A-D
  • Also regulated as biological drug under the FD&C Act and section 351 of the PHS Act
  • Other regulations that apply
    • Labeling and advertising (21 CFR Part 201 and 202)
    • CGMPs (21 CFR Part 211)
    • IND regulations (21 CFR Part 312)
    • Licensing and general biological products standards (21 CFR Parts 600, 601, 610)

HCT/P Regulations

  • General provisions, definitions (21 CFR 1271 Subpart A)
  • Establishment registration (21 CFR 1271 Subpart B) - not required if only manufacturing products under IND
  • Donor eligibility rule (21 CFR Subpart C) - final guidance pending
  • Current Good Tissue Practice (21 CFR Subpart D) - draft guidance under development
  • Reporting - HCT/P deviation and adverse reaction reporting for "361" products only
  • Imported products - field mechanism for expedited entry

Current Good Manufacturing Practice (CGMP)

  • 21 CFR Parts 210 and 211
  • Draft Guidance: INDs - Approaches to Complying with CGMP During Phase 1 (January 2006)
    • Under revision based on comment to the draft rule

When is an IND needed?

  • Minimally manipulated unrelated allogeneic cord blood for homologous use
    • IND moratorium ongoing
  • Cord blood for non-homologous use
  • Cord blood that is more than minimally manipulated
    • Ex vivo expansion

Licensure

  • Draft guidance for minimally manipulated unrelated allogeneic cord blood for homologous use under development
    • Recommendations for applying for a license
  • Requirements to be phased in - announcement will be published in Federal Register
  • Deviation and adverse event reporting under 21 CFR 600.14 and 600.80 for licensed biologic

Regulation of devices for cord blood processing

  • Manufacturers may submit request for device classification - FD&C Act Section 513(g)
  • Examples
    • Automated "closed system" processing devices
    • Final product containers
 
Updated: November 15, 2006