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Germicide 510(k) guidance

This article was originally published in The Gray Sheet

Executive Summary

Document explaining 510(k) requirements for general purpose disinfectants should be completed the week of July 19, according to FDA staffers. Under the guidance, a manufacturer will be required to submit only device labeling, an Environmental Protection Agency registration number, and a cover letter. FDA is revising requirements for general purpose disinfectants in accordance with an FDA/EPA memorandum of understanding reached in June ("The Gray Sheet" June 21, I&W-5). The agreement gives FDA primary jurisdiction over sterilants, while EPA is given primary responsibility for general purpose disinfectants. FDA had issued a guidance document covering all sterilants and disinfectants in January 1992 ("The Gray Sheet" July 6, 1992, 17)....

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