Human Tissue Task Force

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Human Tissue Task Force

Inspections2023 registered establishments; 859 manufacture fromnon-living donorsFocused inspections of 153 musculoskeletal recoveryfirmsAssignment designed to enhance detection of violativepractices that could result in use of ineligible donorsSome deviations identified that require correction but nomajor inaccuracies or deficiencies in records that couldput recipients at risk4


Partnering, Leveraging, Education,and Outreach Federal Partners: CDC, HRSA, FTC States Eye Banking and Tissue Industry Academic and Professional Organizations6


Adverse Reaction Reporting andAnalysis Internal system for receipt, analysis, andfollow-up Tracking /TTSN Tissue processing workshop Other actions with additional planningand/or resources7


Additional Regulations andGuidance Development Guidance clarifying responsibilitiesbetween establishments and contractestablishments Tracking to the recipient DE determination and record review Auditing Contractors Draft CGTP Guidance8


The Science of Tissue Safety Tissue microbiology program Critical path activities and partnerships toevaluate and identify manufacturingpractices that reduce infections diseaserisks9


HTTF: Future Role Issues that require cross-agency,multidisciplinary perspective Track Implementation Discuss emerging issues andopportunities10


Contact InformationCelia Witten, PH.D., M.D.Office Director, OCTGTCBER/FDA1401 Rockville Pike (HFM 700)Rockville, MD 20852-1448celia.witten@fda.hhs.gov301-827-510211

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