Summary of Proposed Changes to 21 CFR 610 is Detailed in New Brief from Microtest Laboratories


The new scope of reusable medical device cleaning validations, resulting from the U.S. Food and Drug Administrations (FDA) proposed changes to 21 CFR 610, is discussed in a new management brief from Microtest Laboratories available for download at .

The FDAs proposed amendments to 21 CFR Parts 600, 610, and 680, published in the Federal Register on June 21, 2011, for review and comment, are focused on expanding the scope of the current sections to allow for greater flexibility in testing methodology.

Through these changes, the FDA is embracing the emergence of new non-culture based technologies. If approved, they will provide the opportunity to utilize these methods as alternatives to culture-based sterility tests, explains James E.T. Gebo, BS, MPA, RM (NRCM), technical representative for laboratory services at Microtest Laboratories, in the brief, Summary of Proposed Changes to 21 CFR 610: The New Scope of Cleaning Validations.

The most significant proposed revision is the elimination of the specified sterility test methods, writes Gebo. But while the proposed changes seem extreme at first glance, in the grand scheme they are beneficial for all interested parties.

The brief discusses the potential benefits, including the opportunity for manufacturers and quality control laboratories to streamline their testing and adopt new emerging sterility test technologies such as rapid testing methods employing PCR that will further support the drive to achieve quicker product release.

Download the new free management brief, Summary of Proposed Changes to 21 CFR 610: The New Scope of Cleaning Validations, at

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