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FDA Completes “Risk-Based” Reg Trilogy With Good Tissue Practices

This article was originally published in The Gray Sheet

Executive Summary

Manufacturers of tissue products have until May 25 to implement a comprehensive tissue tracking system under the 1Good Tissue Practice (GTP) regulations finalized Nov. 18

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Regulatory News In Brief

UDI workshop: Planned unique device identification system is up for discussion at a Feb. 12 FDA public workshop in Gaithersburg, Md. In the Jan. 15 Federal Register notice announcing the meeting, FDA lists a set of questions it hopes to tackle at the gathering - including what types of devices should be required to be marked with bar code-like identifiers; what technologies should be employed to achieve unique device identification; and the logistical and economic impact of having to add identifiers to certain devices. The 2007 FDA Amendments Act requires FDA to develop a mandatory UDI system, but gives the agency the authority to establish alternatives and exceptions. CDRH has been in talks with manufacturers, hospitals, purchasing groups and other stakeholders for at least the past three years about developing such a system as part of its plan to improve postmarket device safety oversight (1"The Gray Sheet" Feb. 6, 2006, p. 3)

Regulatory News In Brief

UDI workshop: Planned unique device identification system is up for discussion at a Feb. 12 FDA public workshop in Gaithersburg, Md. In the Jan. 15 Federal Register notice announcing the meeting, FDA lists a set of questions it hopes to tackle at the gathering - including what types of devices should be required to be marked with bar code-like identifiers; what technologies should be employed to achieve unique device identification; and the logistical and economic impact of having to add identifiers to certain devices. The 2007 FDA Amendments Act requires FDA to develop a mandatory UDI system, but gives the agency the authority to establish alternatives and exceptions. CDRH has been in talks with manufacturers, hospitals, purchasing groups and other stakeholders for at least the past three years about developing such a system as part of its plan to improve postmarket device safety oversight (1"The Gray Sheet" Feb. 6, 2006, p. 3)

FDA introduces human tissue task force

The group is charged to assess the effectiveness of new tissue regulations that took effect in May 2005, focusing on recent findings that some tissue recovery establishments do not follow federal requirements, the agency said Aug. 30 (1"The Gray Sheet" Nov. 22, 2004, p. 6). "The creation of this task force is part of the agency's overall plan to ensure that all human cells and tissues are as safe as possible," said Jesse Goodman, MD, director of the Center for Biologics Evaluation & Research. On Aug. 18, FDA ordered Donor Referral Services to cease manufacturing of human cells, tissues and cellular and tissue-based products and to retain all such products. An FDA inspection of the Raleigh, N.C., operation found "serious" violations of manufacturing procedures and recordkeeping requirements...

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