Notice of Updates | FDA

Notice of Updates | FDA 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lefamulin, and polymyxin B. FDA has also removed telithromycin breakpoints as the drug has been withdrawn.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.