Notice of Updates – FDA Recognized Antimicrobial Susceptibility Test Interpretive Criteria FDA Updates FDA recognizes, as of October 14, 2021, with certain exceptions, the standards published in: Clinical and Laboratory Standards Institute (CLSI). Performance Standards for Antimicrobial Susceptibility Testing. 31st ed. CLSI supplement M100. Wayne, PA: Clinical and Laboratory Standards Institute; 2021. Also, FDA recognizes in part the standards published in: Clinical and Laboratory Standards Institute (CLSI). Performance Standards for Susceptibility Testing of Mycobacteria, Norcardia spp. and other Aerobic Actinomycetes. CLSI guideline M62- 1st Edition. Wayne, PA: Clinical and Laboratory Standards Institute; 2018. In addition, FDA updated recognition of the susceptibility test interpretive criteria (STIC) for azithromycin, cefazolin, cefiderocol, ceftolozane tazobactam, colistimethate, imipenem-cilastatin-relebactam, lefamulin, and polymyxin B. FDA has also removed telithromycin breakpoints as the drug has been withdrawn. For additional information about the FDA susceptibility test interpretive criteria recognition please visit http://www.fda.gov/STIC. ** If you did not subscribe to the FDA Recognized Antimicrobial STIC Breakpoints subscription you may unsubscribe from this list by clicking on the "Manage Preferences or Unsubscribe from this List" link below. |
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