CBER Presentation
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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- Current Good Tissue Practice (21 CFR Subpart D) - draft guidance under development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- Draft Guidance: INDs - Approaches to Complying with CGMP During Phase 1 (January 2006)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- Draft guidance for minimally manipulated unrelated allogeneic cord blood for homologous use under development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