Tissue banks : the dangers of tainted tissues and the need for federal regulation : hearing before the Committee on Governmental Affairs, United States Senate, One Hundred Eighth Congress, first session, May 14, 2003.
- United States. Congress. Senate. Committee on Governmental Affairs
- Date:
- 2003
Licence: Public Domain Mark
Credit: Tissue banks : the dangers of tainted tissues and the need for federal regulation : hearing before the Committee on Governmental Affairs, United States Senate, One Hundred Eighth Congress, first session, May 14, 2003. Source: Wellcome Collection.
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![In addition to laboratory testing, a critical component of enhancing the safety of tissues is excluding donors who may pose a higher risk of transmission of infectious diseases. The emerging challenges of prion diseases [such as CJD and variant CJD (vCJD)], for which there currently are no practical laboratory tests, pose a particular challenge, especially for nervous system tissues. Because of our concern about the potential transmission of these diseases by transplantation, implantation, infusion, or transfer of human cells, tissues and cellular, and tissue-based products (HCT/Ps), FDA issued guidance on June 14, 2002, regarding deferral criteria for donors potentially at risk of developing and transmitting these diseases. We published this draft guidance to present our current thinking about preventing the potential transmission of this disease by deferring donors with possible exposure. FDA intends to issue another draft guidance document for public comment that would include recommendations to screen and test donors for relevant communicable diseases other than CJD and vCJD, and combining both draft guidance documents into one final guidance of that time. . Dura Mater Proposed Rule On October 22, 2002, FDA’s Center for Devices and Radiological Health (CDRH) published a proposed rule to classify human dura mater as a Class II device. Class II means we know enough about the device category to establish controls for reasonable assurance of safety and effectiveness. A draft guidance document was published on the same day to support the proposed classification. The 90-day comment period for the proposed rule and the draft guidance document ended on January 21, 2003. The comments are currently under review.](https://iiif.wellcomecollection.org/image/b32221514_0074.jp2/full/800%2C/0/default.jpg)
