Food and Drug Administration

Requirements for Human Blood and Blood Components Intended for Transfusion or for Further Manufacturing Use; Proposed Rule

Background Information Regarding the ISBT Label

Revisions to the Requirements Applicable to Blood, Blood Components and Source Plasma: Direct Final Rule

Draft Guidance for Industry: Cell Selection Devices for Point of Care Production of Minimally Manipulated Autologous Peripheral Blood Stem Cells (PBSCs)

Recall of m2000sp and m1000 Instrument

Recall of CS3000 Apheresis Kits

Q&As Concerning Establishment Registration and Listing for HCT/Ps

Recall of Medical Devices - Biomet Biologics, Inc

Important Notification: Fast Flow Fluid Warmers - Smiths Medical

Potential Risk of Variant Creutzfeldt-Jakob Disease (vCJD) from Plasma-Derived Products

Cellular, Tissue and Gene Therapies Advisory Committee (CTGTAC) Meeting (March 29 - 30, 2007)

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
This guidance is for immediate implementation.

Guidance for Industry
Minimally Manipulated, Unrelated, Allogeneic Placental/Umbilical Cord Blood Intended for Hematopoietic Reconstitution in Patients with Hematological Malignancies

Donor Screening Tests for Testing HCT/P Donors - Updated

Variances for Collection of Blood and Blood Products from Patients with Hemochromatosis - Update

Guidance for Industry: Class II Special Controls Guidance Document: Cord Blood Processing System and Storage Container

Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Guidance for Industry and Food and Drug Administration Staff on Class II Special Controls Guidance Document: Automated Blood Cell Separator Device Operating by Centrifugal or Filtration Separation Principle

Electronic Biological Product Deviation Reporting (eBPDR) Latest System Changes

Substantially Equivalent 510(k) Device - TANGO Automated Blood Bank Analyzer System, Version 3.0 Service Pack 4 - Biotest AG

Devices Regulated by CBER - Updated

FDA Approves New Product to Treat Von Willebrand Disease

Medical Devices 101: An Educational Forum
FDA's medical device requirements for entrepreneurs, startup companies, and small businesses.

Collaborative Scientific Training Program

CBER Presentation: Celia M.Witten, PhD, MD. Cell Therapy in Multiple Sclerosis: FDA Regulatory Issues

FDA Reviews Comments on Device-ID System
The U.S. Food and Drug Administration (FDA) is making progress on its efforts to determine whether it will require companies to use a unique device identification (UDI) system to track and trace medical devices they manufacture and supply.