Understanding the Clinical In-Use Test

The last part of every FDA 510(k) submission for a high-level disinfectant is testing the product in actual clinical use. Microchem is one of the few labs in the country with the skills and experience to conduct such testing.

The Consumer Specialty Products Association (CSPA) is the premier trade association for companies that formulate, manufacture, and distribute regulated consumer products including disinfectants.  Microchem Laboratory recently attended the mid-year meeting held in National Harbor, Maryland.  Industry representatives, consultants, and regulatory officials gathered to discuss a variety of topics related to consumer products ranging from regulation to registration.  This year's meeting, called "Impact 2016," was focused on making an impact on the industry, customers and current events.

EPA representatives discussed the agency's process for method development and revision with emphasis on the value of stakeholder input throughout the process.  Revisions to existing guidance documents were discussed, to include the 810 series, emerging viral pathogen claims and confirmatory testing.  EPA representatives announced the release of new guidance for C. difficile and biofilm testing for 2016.  That guidance is anticipated as early as this summer.  The agency emphasized the importance of continued industry/government collaboration throughout the upcoming months as new and revised guidance becomes available.

Contact the lab for more information about the meeting, the topics discussed and how they may affect current and future registrations. 

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An FDA GLP and GCP-compliant testing organization staffed by skilled, experienced microbiologists and subject recruiters.  ECRL can help speed your project to completion.