FDA withdraws 21 CFR Part 11 guidance document

Rockville, MD – The U.S. Food and Drug Administration (FDA) announced Feb. 3rd it would withdraw its recently released 21 CFR Part 11 electronic copies guidance draft. In the past, withdrawing a guidance document has suggested the FDA is significantly rethinking its approach to regulation enforcement.

In August 2001, FDA announced it was undertaking a new initiative to enhance its current good manufacturing practice program (CGMP). According to FDA spokespersons, ”The new initiative will focus FDA’s resource’s and regulatory attention on those aspects of manufacturing posing the greatest risk, ensure FDA’s work does not impede innovation, and enhance the consistency of FDA’s regulatory approach among various components.”

Under the new initiative, primary responsibility for implementing 21 CFR Part 11-electronic records and signatures-has shifted to the Center for Drug Evaluation and Research, with continued involvement from other Centers and the Office of Regulatory Affairs.

FDA issued the guidance document, titled ”Guidance for Industry, 21 CFR Part 11: Electronic Records, Electronic Signatures, Electronic Copies of Electronic Records,” on November 12, 2002. An agency spokesperson says, ”The agency wishes to limit the time spent by industry reviewing and commenting on the guidance, which may no longer represent FDA’s approach under the CGMP initiative. The agency may decide to reissue the draft guidance once it has reviewed it under the CGMP initiative.”

The FDA’s August and February announcements use carefully worded statements, but presumably these changes are aimed at helping stimulate the U.S. economy.

For more information, visit www.fda.gov

Control Engineering Daily News DeskDave Harrold, senior editor dharrold@reedbusiness.com

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