U.S. flag An official website of the United States government
  1. Home
  2. Drugs
  3. Development & Approval Process | Drugs
  4. Development Resources
  5. FDA-Recognized Antimicrobial Susceptibility Test Interpretive Criteria
  1. Development Resources

FDA-Recognized Antimicrobial Susceptibility Test Interpretive Criteria

Looking for FDA-Recognized Susceptibility Test Interpretive Criteria?

Looking for recent updates? Please see: Notices of Updates

Sign up to receive FDA Recognized Antimicrobial STIC Breakpoints email notifications Little Envelope

These web pages provide information about the in vitro susceptibility of bacteria or fungi to certain drugs. The safety and efficacy of these drugs in treating clinical infections due to such bacteria or fungi may or may not have been established in adequate and well-controlled clinical trials and the clinical significance of such susceptibility information in those instances is unknown. The approved product labeling for specific drugs provides the uses for which the product is approved.


The 21st Century Cures Act (Cures Act) , signed into law on December 13, 2016, helps accelerate medical product development and bring new innovations and advances to patients who need them faster and more efficiently. Section 3044 of the Cures Act created a system to expedite the recognition of antimicrobial susceptibility test interpretive criteria also known as “breakpoints” (abbreviated as STIC) and provide up-to-date information to the healthcare community in a more streamlined manner.

Changes made by the 21st Century Cures Act

Susceptibility Test Interpretive Criteria (STIC) – new online information

The Cures Act requires FDA to post information online about FDA’s recognition, or withdrawal from recognition, in whole or in part, of STIC established by a standards development organization (SDO) and online lists of exceptions or additions to the recognized STIC that the SDO established. This information should be referred to as the most up-to-date STIC for antibacterial and antifungal drugs. Online references allow FDA to more quickly communicate updated STIC than updating and re-updating labeling.

STIC are listed by therapeutic category (antibacterial or antifungal):

The agency will update this information at least every six months through publication of a notice on this page. Annually FDA will publish a compilation of these notices on the Federal Register for public comment. Changes could include:

  • Recognizing new or updated STIC standards, or parts of standards;
  • Withdrawing recognition of STIC standards, or parts of standards; and/or
  • Making any other necessary updates to the published lists.

As applicable, FDA will also post STIC on these web pages for newly approved drugs at the time of their approval.

Susceptibility Test Interpretive Criteria in drug labels – a shift to online updates (Guidance for Industry – Systemic Antibacterial and Antifungal Drugs: Susceptibility Test Interpretive Criteria Labeling for NDAs and ANDAs)

To ensure that the most up-to-date STIC are available, holders of approved drug applications had until December 13, 2018, to remove the STIC information and related information from the labeling of approved systemic antibacterial and antifungal drugs and replace it with a reference to information on these new pages. FDA has published a final guidance to further explain these requirements.

New antibacterial and antifungal drugs approved on or after December 13, 2017 will include a reference to information on these new pages in labeling in lieu of STIC and related information.

FDA has established a docket for public comment where interested third parties or drug sponsors may provide information that FDA could consider in determinations concerning recognition of a susceptibility test interpretive criteria standard or could use as a basis for listing new or for updating susceptibility test interpretive criteria. FDA will review all substantive submissions to support updating of susceptibility test interpretive criteria. When the review is completed, FDA will provide information in the Notice of Updates section of these webpages.

Contact Information: Questions regarding STIC should be directed to the Office of Infectious Diseases (OID), Office of New Drugs (OND), Center for Drug Evaluation and Research (CDER) at 301-796-1300 or stic@fda.hhs.gov.

Questions regarding the clearance, classification, or approval of antimicrobial susceptibility testing devices should be directed to the Division of Industry and Consumer Education (DICE) in FDA’s Center for Devices and Radiological Health (CDRH) at 1-800-638-2041, 301-796-7100 or at dice@fda.hhs.gov.


Back to Top