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USDA BSE Import Restrictions For IVDs Delayed To Allow Policy Discussion

This article was originally published in The Gray Sheet

Executive Summary

Importers of bulk in vitro diagnostic products that contain ruminant-derived material from countries with bovine spongiform encephalopathy (BSE) risk will have an additional two months to convince USDA not to cancel their import certificates

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Part 11: FDA plans to publish draft guidance on use of computerized systems in clinical trials by the end of August. The "Part 11" draft guidance will replace a guidance on the same topic published in April 1999 and align the guidelines with policy articulated in FDA's broader guidance released in August 2003: "Part 11, Electronic Records; Electronic Signatures - Scope and Application" (1"The Gray Sheet" Sept. 8, 2003, In Brief). The forthcoming draft guidance is expected to outline general principles that should be followed when computerized systems are used to create, modify, maintain, archive, retrieve or transmit clinical trial data to ensure that electronic records meet regulatory standards and requirements. Many of the guidance's general principles are expected to address clinical trial electronic record security...

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Part 11: FDA plans to publish draft guidance on use of computerized systems in clinical trials by the end of August. The "Part 11" draft guidance will replace a guidance on the same topic published in April 1999 and align the guidelines with policy articulated in FDA's broader guidance released in August 2003: "Part 11, Electronic Records; Electronic Signatures - Scope and Application" (1"The Gray Sheet" Sept. 8, 2003, In Brief). The forthcoming draft guidance is expected to outline general principles that should be followed when computerized systems are used to create, modify, maintain, archive, retrieve or transmit clinical trial data to ensure that electronic records meet regulatory standards and requirements. Many of the guidance's general principles are expected to address clinical trial electronic record security...

USDA Import BSE Restriction Waiver Sought For IVD Products

FDA and AdvaMed will meet with USDA during the first week of September to discuss whether BSE import restrictions should apply to in vitro diagnostic (IVD) products that contain ruminant-derived materials

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