Martha A Wells, MPH Division of Human Tissues OCTGT, CBER, FDA. Pharma Conference HCT/P Meeting January 24, 2007 San Antonio, TX

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1 Guidance for Industry: Certain Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) Recovered From Donors Who Were Tested For Communicable Diseases Using Pooled Specimens or Diagnostic Tests Martha A Wells, MPH Division of Human Tissues OCTGT, CBER, FDA Pharma Conference HCT/P Meeting January 24, 2007 San Antonio, TX

2 Introduction Guidance issued January 24, 2007 for immediate implementation Certain HCT/Ps Hematopoietic stem cells Reproductive cells and tissues Pertains to those HCT/Ps recovered on or after May 25, 2005 and within 30 days of FR notice

3 Background Donor Screening and Testing became effective May 25, 2005 (21 CFR Part 1271, Subpart C) Since learned that some testing laboratories have tested HCT/Ps inconsistent with manufacturer s s instructions for the tests Pooled NAT testing (HCT/P donors must be tested using individual NAT) Diagnostic vs. screening (HCT/P donors must be tested with donor screening tests) Both pooled and diagnostic tests are less sensitive and have potential for introducing additional risk of communicable disease transmission

4 Investigation & Corrective Actions Identify, quarantine, and do not distribute all HCT/Ps from such donors that are in inventory Identify all HCT/Ps from such donors that were distributed In-house testing Investigate, identify HCT/Ps and report those affected in deviation report (21 CFR (b)); or Testing under contract/agreement Laboratory must notify affected HCT/P establishments (21 CFR (b)(2)(ii)) Establishment should investigate, identify HCT/Ps and report those affected in deviation report Appropriate corrective actions must be taken (21 CFR (b)(2)&(3))

5 Do I Need to Submit a HCT/P Deviation Report? Must submit deviation reports related to core CGTP requirements Donor testing is a core CGTP requirement Deviations are only reported on HCT/Ps that have already been distributed Establishment that distributes HCT/Ps related to deficiency in donor testing must report the deviation

6 Do I Need to Submit a HCT/P Deviation Report? Required: Hematopoietic stem cells derived from peripheral or cord blood, distributed for use in first or second-degree degree blood relatives (related allogeneic) -Per 21 CFR (b) Not Required Reproductive HCT/Ps Reporting requirements do not apply (Subpart D and E do not apply to reproductive HCT/Ps at this time)

7 HCT/P Deviation Reports Not Required For Hematopoietic Stem Cells Distributed for autologous use Donor testing not required under section 361 of PHS Act Distributed for use in unrelated allogeneic recipients Regulated under section 351 of PHS Act, when licensed, report under 21 CFR If under IND, amendment should be submitted to file (21 CFR )

8 How Do I Submit a Deviation Report? One report for all affected HCT/Ps Use Form FDA 3486 (Biological Product Deviation Reports) Electronically as directed on web at By mail to the Director, Office of Compliance and Biologics Quality, Center for Biologics Evaluation and Research (HFM-600), 1401 Rockville Pike, Suite 200N, Rockville, MD

9 What Information Must the Deviation Report Contain? Description of HCT/P deviation Information relevant to the event or manufacture of the HCT/P involved All follow-up action that has been or will be taken in response to the HCT/P deviation (21 CFR (b)(2))

10 HCT/Ps in Inventory When possible: Donor specimens originally pooled for NAT testing should be retested individually; or Donor specimens originally tested using diagnostic tests should be retested using the appropriate FDA approved screening tests Specimens used in retesting should be collected within the specified time frames when possible (21 CFR (b)) If these time frames have elapsed retesting should still be performed

11 Hematopoietic Stem Cell Donors (Other than Autologous) Should be retested If results are negative or non reactive FDA intends to exercise enforcement discretion If retesting is not feasible FDA intends to exercise enforcement discretion provided that: Accompanying records state the reason retesting could not be performed; file kept on record Establishment documents that recipient s physician was notified of results Labeling must include WARNING: Advise patient of communicable disease risks

12 Reproductive HCT/P Donors (Cryopreserved Embryos) Formed for sexually intimate partners using a third party gamete donor If the third party gamete donor is retested and results are negative or non reactive FDA intends to exercise enforcement discretion If retesting is not feasible FDA intends to exercise enforcement discretion provided that: Accompanying records state the reason retesting could not be performed; file kept on record Establishment documents that recipient s s physician was notified of results Labeling must include WARNING: Advise patient of communicable disease risks

13 Reproductive HCT/P donors (Cryopreserved Semen or Oocytes) Directed or anonymous If results are negative or non reactive FDA intends to exercise enforcement discretion If retesting is not feasible, HCT/Ps must not be distributed

14 Required Labeling for Distribution Without Retesting WARNING: Advise patient of communicable disease risks Include original pooled NAT test results and name of test in the summary of records along with qualifier not performed according to manufacturer s s instructions ; ; or Include diagnostic test results and name of test in the summary of records along with qualifier - diagnostic tests used instead of donor screening tests

15 Contact Information Martha A. Wells, MPH 1401 Rockville Pike, HFM-775 Rockville, MD FAX b