CBER Presentation
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Donor Issues Scenario Based Panel
"FDA Introduction"
ISCT 6th Annual Somatic Cell Therapy Symposium
26 September 2006
Melissa A. Greenwald, MD
Overview
- Introduction
- Overview of regulations and guidance
- Resources
- Contact information
Legal Authority
- Public Health Service Act
- Section 361-The Surgeon General, with the approval of the Secretary, is authorized to make and enforce such regulations as in his judgment are necessary to prevent the introduction, transmission, or spread of communicable diseases from foreign countries into the States or possessions, or from one State or possession into any other State or possession.
Overview of US Tissue-related regulations currently in place
| Regulation Subparts | Proposed | Final | Effective Date |
|---|---|---|---|
| Establishment Registration and Product Listing | 1998 | 2001 | 2001 for establishments regulated under 1270; 2004 for newly regulated establishments |
| Donor Eligibility | 1999 | 2004 | May 25, 2005 |
| Current Good Tissue Practices (GTP): Inspection and Enforcement | 2001 | 2004 | May 25, 2005 |
Guidance
- Draft - Preventive Measures to Reduce the Possible Risk of Transmission of CJD/vCJD by Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) - June 2002
- Draft - Eligibility Determination for Donors of HCT/Ps - May 2004
- Final - donor eligibility guidance will combine the above drafts - FDA is addressing comments to the docket
- Compliance with 21 CFR Part 1271.150(c)(1) - Manufacturing Arrangements - September 2006
- MedWatch Form 3500A: Mandatory Reporting of Adverse Reactions Related to HCT/Ps - November 2005
- Recommendations for Obtaining a Labeling Claim for Communicable Disease Donor Screening Tests Using Cadaveric Blood Specimens from Donors of HCT/Ps - November 2004
- Current Good Tissue Practices guidance - currently leveraging with industry professional associations to develop draft guidance
- http://www.fda.gov/cber/tissue/docs.htm
Donor Testing Information
- Donor Screening Tests for HCT/P Donors http://www.fda.gov/cber/tissue/prod.htm
- Additional information on other donor screening tests with indications for use in living donors can be found at http://www.fda.gov/cber/products/testkits.htm
Contact Information
- Melissa Greenwald
301-827-2002
melissa.greenwald@fda.hhs.gov - Ellen Lazarus
301-827-6031
ellen.lazarus@fda.hhs.gov