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Antimicrobial Resistance

FDA's role in antimicrobial resistance (AMR) preparedness and response, and information about AMR

Image
Scanning electron micrograph of methicillin-resistant Staphylococcus aureus (MRSA, brown) surrounded by cellular debris. MRSA resists treatment with many antibiotics. Credit: NIAID
Caption
Scanning electron micrograph of methicillin-resistant Staphylococcus aureus (MRSA, brown) surrounded by cellular debris. MRSA resists treatment with many antibiotics. (Credit: NIAID)

On this page:
What's new | The FDA's role and strategic approach | Product development | Antimicrobial stewardship | Surveillance and monitoring | Regulatory science | FDA publications | Information for consumers | Press and statements | Events | Interagency collaboration | Contact the FDA

Antimicrobial resistance (AMR)—the ability of a microorganism (bacteria, virus, fungi, parasite) to resist the effects of a drug—is a serious, complex and costly public health problem.

According to the Centers for Disease Control and Prevention (PDF, 148 pages), each year in the United States at least 2.8 million antibiotic-resistant infections occur, and more than 35,000 people die as a result. Combating AMR requires multifaceted efforts in both the healthcare and veterinary sectors.

What's new

  • October 10, 2024: The FDA announced the publication of the 2023 Summary Report on Antimicrobials Sold or Distributed for Use in Food-Producing Animals. The 2023 data indicate that U.S. sales and distribution of medically important antimicrobial drugs approved for use in food-producing animals decreased by 2% between 2022 and 2023; this represents a 37% decrease in sales since the sales peaked in 2015.

  • October 9, 2024: The U.S. Environmental Protection Agency (EPA) finalized its framework for expanding federal collaboration on the review of antibacterial and antifungal pesticides. In developing the framework, EPA coordinated with the U.S. Department of Health and Human Services (HHS) and the U.S. Department of Agriculture (USDA), under the oversight of the White House Office of Science and Technology Policy. The framework establishes a process for EPA to consider input from the other federal agencies on whether use of antibacterial or antifungal pesticides might reduce the effectiveness of some human and animal antibacterial and antifungal drugs.

  • September 25, 2024: The FDA announced it is awarding funds for three projects to collect, analyze and report data on antimicrobial use (AMU) in animals. These projects support long term AMU data collection efforts under development within the U.S, including proposed public-private partnership frameworks for tracking AMU data.

The FDA's role and strategic approach

Antimicrobial resistance is recognized as a growing global threat. In 2014, the White House announced the National Strategy for Combating Antibiotic-Resistant Bacteria (CARB), underscoring the need for a coordinated inter-agency response to this threat. The FDA has been and continues to be integral in these efforts.

Several of FDA’s Centers—including the Center for Drug Evaluation and Research (CDER), Center for Devices and Radiological Health (CDRH), Center for Biologics Evaluation and Research (CBER), Center for Veterinary Medicine (CVM), National Center for Toxicological Research (NCTR), and the Office of the Chief Scientist—play key roles in combating AMR. 

The FDA is dedicated to addressing the challenges AMR presents by helping to preserve the effectiveness of currently available antimicrobial drugs and promoting the development of new medical products that can help reduce the emergence and spread of AMR bacteria.

Working with both domestic and international partners, the FDA is proactively addressing the complex challenges associated with the growing threat of AMR by:

  • Facilitating efficient product development to address AMR, including the development of new antimicrobials, diagnostic tests, and vaccines
  • Promoting the appropriate and responsible use of antimicrobials and disseminating information promoting interventions that help slow the development of resistance
  • Supporting the development and enhancement of tools for conducting surveillance of antimicrobial use and resistance so stakeholders can better track, treat, or respond to AMR outbreaks
  • Advancing regulatory science to develop the tools, standards, and approaches to facilitate the translation of breakthrough discoveries in science and technology into innovative, safe, and effective medical products

To achieve this mission, the FDA will continue to work collaboratively with Congress, its partners at other U.S. government agencies, and other stakeholders to find additional ways to prevent, detect, and address AMR.

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Product development

The FDA works closely with product sponsors and other government agencies to facilitate efficient product development to address AMR, including new antimicrobial drugs, biologics (including human vaccines), and diagnostics. 

  • The FDA employs a variety of mechanisms, where appropriate, to help speed the development and availability of medical products for humans: Fast track designation, priority review, and breakthrough therapy designation.
  • Under Generating Antibiotic Incentives Now (Report to Congress; PDF, 545 KB), or GAIN, the FDA is authorized to provide a five-year extension of exclusivity to incentivize the development of new Qualified infectious disease products (QIDPs) (PDF, 390 KB). A QIDP is defined as “an antibacterial or antifungal drug for human use intended to treat serious or life-threatening infections, including those caused by an antibacterial or antifungal resistant pathogen.” As of August 2018, the FDA has approved 15 new QIDPs for bacterial or fungal infections.
  • Established by Congress under the 21st Century Cures Act, the Limited Population Pathway for Antibacterial and Antifungal Drugs, or LPAD pathway, is a new step to help advance development of  antimicrobial drugs for limited populations of patients with unmet need. 
  • The FDA is also in discussion with other agencies including the Centers for Medicare and Medicaid Services (CMS) to explore the means for reimbursement of certain new antibacterial drugs that meet critical patient and public health needs.  

The FDA is working to advance the development of nontraditional antimicrobial products including:

The FDA is also working to advance the development of vaccines for organisms contributing to AMR.

The FDA encourages the development of novel in vitro diagnostic (IVD) devices for detection of AMR associated with microbial pathogens. Also see: Antimicrobial Susceptibility Testing - Helping Health Care Providers Determine the Appropriate Antimicrobial Agent for Treatment

When searching for AMR-related device approvals it is helpful to know the associated Product Code for the class of AMR-related devices.

  • You can find these codes in the CDRH Product Classification database, by searching for the terms susceptibility, antimicrobial, or resistance in the “device” section.
  • While not a complete list, examples of Product Codes associated with AMR-related device approvals include: JTN, JWY, LON, LTT, LRG, LTW, PEN, PAM, and POC.
  • These Product Codes include phenotypic antimicrobial susceptibility test (AST) devices and devices that determine AMR by other means, such as genetic markers. (FDA maintains a list of cleared or approved Microbial Nucleic Acid Devices; please note that this list also includes other devices that do not detect genetic markers of resistance.)
  • Knowing the Product Code also makes it easier to find specific AMR-related device approvals when searching the PMA, de novo, and 510(k) databases.

April 30, 2024: BioMérieux is recalling VITEK 2 AST cards, an AST kit, due to a higher concentration of ceftriaxone antibiotic in two wells. This kit is used for testing how sensitive bacteria are to antibiotics. 

  • Recently cleared IVD devices, including Antimicrobial Susceptibility Test (AST) devices, include:

    • February 15, 2024: The FDA cleared the PBC [positive blood culture] Separator with Selux Antimicrobial Susceptibility Testing (AST) System from Selux Diagnostics, Inc. to be marketed in the U.S. The PBC Separator with Selux AST System is an automated lab inoculation preparation system intended for use with positive blood culture samples that can be used for quantitative in vitro antimicrobial susceptibility testing without the traditional overnight subculture.
    • July 6, 2023: The FDA cleared HardyDisk AST Sulbactam/Durlobactam 10/10μg (SUD20) (K231568), a disk diffusion assay for in vitro susceptibility testing of Sulbactam/Durlobactam, a new drug approved for the treatment of hospital-acquired bacterial pneumonia (HABP) and ventilator-associated bacterial pneumonia (VABP) caused by Acinetobacter baumannii-calcoaceticus complex. This assay was cleared just 6 weeks after new drug approval.
    • July 5, 2023: The FDA cleared VITEK 2 AST-Gram Positive Daptomycin (≤0.12 - ≥8 µg/mL) (K230864), a miniaturized, abbreviated and automated version of the classic broth dilution method to determine the minimum inhibitory concentration of daptomycin, an antibiotic with updated breakpoints for testing Enterococcus faecalis. In addition, claims for testing vancomycin-resistant E. faecalis were added due to FDA recognition of breakpoints.
    • May 4, 2023: The FDA cleared the BD Kiestra Methicillin-resistant Staphylococcus aureus (MRSA) Application (K213280), an in vitro diagnostic software program for use with the BD Kiestra Laboratory Automation Solution for the qualitative assessment of microbial colonies on chromogenic culture media to aid in the prevention and control of methicillin-resistant Staphylococcus aureus (MRSA) infection.
    • April 19, 2023:  The FDA cleared the Selux AST System (K211748) for use with the Selux Gram-Negative Comprehensive Panel through the 510(k) premarket notification pathway. This follows clearance (K211759) of the system earlier this year for use with the Selux Gram-Positive Comprehensive Panel. The Selux AST System is an in vitro diagnostic test system used for antimicrobial susceptibility testing. This testing is performed to determine whether an organism is susceptible or resistant to an antimicrobial drug to help physicians select the appropriate drug to treat an infection. The Selux AST System allows for simultaneous testing of a larger number of drugs and drug concentrations than previous systems. The two panels also have the ability to expand to incorporate new drugs in the future. Susceptibility testing systems use FDA-recognized cut-off values (referred to as susceptibility test interpretive criteria or breakpoints), to indicate whether the drug is likely to be effective (drug concentrations below the cut-off are likely to be effective, and drug concentrations above the cut-off are not likely to be effective). Since breakpoints can be updated to maintain clinical success of the drug, the Selux AST System was also cleared with a prospective change protocol, allowing the developer to update breakpoints without an additional premarket submission to the FDA.  This is the latest example of the FDA’s ongoing commitment to advance access to safe and effective antimicrobial susceptibility testing intended to aid healthcare professionals in making more informed decisions for patients.
    • March 21, 2023: The FDA cleared the Sensititre 20–24-hour Haemophilus influenzae/Streptococcus pneumoniae MIC or Breakpoint Susceptibility System with Delafloxacin in the dilution range of 0.00025-8 µg/ml (Streptococcus pneumoniae) and 0.000125-8 µg/ml (Haemophilus influenzae) (K223844) a miniaturized version of the classic broth dilution method to determine the minimum inhibitory concentration of delafloxacin, an antibiotic approved for the treatment of community-acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infections (ABSSSI). Claims were added for testing Streptococcus pneumoniae and Haemophilus influenzae isolates recovered from CABP.
    • March 20, 2023: The FDA cleared the Colibri System (K223245), an automated pre-analytical processor that picks isolated colonies to prepare MALDI-TOF MS target slides for bacterial identification and microbial suspensions at a known concentration for antimicrobial susceptibility testing. This system is an updated workflow from the previously cleared semi-automated system. 
    • March 10, 2023: The FDA cleared the Sensititre YeastOne Susceptibility System with Fluconazole in the dilution range of 0.12-128 μg/mL (K221198), a miniaturized version of the classic broth dilution method to determine the minimum inhibitory concentration of fluconazole, an antifungal agent with updated breakpoints for testing C. albicans, C. glabrata, and C. parapsilosis.
    • March 9, 2023: The FDA cleared the VITEK 2 AST-Gram Negative Fosfomycin (≤4 - ≥256 µg/mL) (K222430), a miniaturized, abbreviated and automated version of the classic broth dilution method to determine the minimum inhibitory concentration of Fosfomycin, an antibiotic used for the treatment of urinary tract infection.
    • February 16, 2023: The FDA cleared the VITEK 2 AST-Gram Negative Plazomicin (≤0.5 – ≥16 μg/mL) (K223478), a miniaturized, abbreviated and automated version of the classic broth dilution method to determine the minimum inhibitory concentration of Plazomicin, an antibiotic used for the treatment of complicated urinary tract infection.
    • February 9, 2023: The FDA cleared the VITEK 2 AST-Gram Negative Cefazolin (≤1 – ≥32 μg/mL) (K222073), a miniaturized, abbreviated and automated version of the classic broth dilution method to determine the minimum inhibitory concentration of Cefazolin, an antibiotic used for the treatment of various infections as well as for perioperative prophylaxis to reduce incidence of certain postoperative infections.
    • February 3, 2023: The FDA cleared the VITEK 2 Streptococcus Tetracycline (≤ 0.25 - ≥ 16 μg/ml) (K223481), a miniaturized, abbreviated and automated version of the classic broth dilution method to determine the minimum inhibitory concentration of Tetracycline an antibiotic with updated breakpoints for testing Streptococcus pneumoniae, Streptococcus pyogenes (Group A Beta-Hemolytic streptococci) and Streptococcus spp. β-Hemolytic Group species.
    • January 27, 2023: The FDA cleared the VITEK 2 AST-Gram Positive Moxifloxacin (≤0.25 - ≥ 8μg/ml) (K220803), a miniaturized, abbreviated and automated version of the classic broth dilution method to determine the minimum inhibitory concentration of Moxifloxacin an antibiotic with updated breakpoints for testing Enterococcus faecalis, Staphylococcus aureus and other Staphylococcus species. 
    • January 20, 2023: The FDA cleared the Sensititre YeastOne Susceptibility System with Caspofungin in the dilution range of 0.015-16ug/ml (K221899), a miniaturized version of the classic broth dilution method to determine the minimum inhibitory concentration of Caspofungin, an antifungal agent with updated breakpoints for testing Candida spp.
    • January 18, 2023: The FDA cleared the Selux AST System; Model AST Gen 1.0 (K211759), a semi-automated and miniaturized version of the classic broth dilution method to simultaneously determine the minimum inhibitory concentration of 15 antimicrobials against select Enterococcus and Staphylococcus species, representing 35 different antimicrobial/organism combinations using the Selux Gram Positive Panel.  Unlike traditional 96-well panels, the 384-well panel facilitates addition of new antimicrobials for testing as they become available.
    • December 21, 2022: The FDA cleared the BD BBL Sensi-Disc Cefiderocol 30ug (FDC-30) (K221826), a disk diffusion assay for in vitro susceptibility testing of Cefiderocol, an antibiotic recently approved for the treatment of complicated urinary tract infections.
    • October 13, 2022: The FDA cleared the VITEK 2 AST-Gram Positive Cefoxitin (K220805), a miniaturized, abbreviated and automated version of the doubling dilution technique designed to predict mecA-mediated oxacillin resistance in Staphylococcus spp.
    • October 5, 2022: The FDA cleared an expanded indication for the Colibrí System (K220546), a semi-automated pre-analytical processor, to prepare microbial suspensions at a known concentration for antimicrobial susceptibility testing 

    • September 15, 2022: The FDA cleared the Thermo Scientific Oxoid Omadacycline Disc (30 ug) OMC30 (K203336), a disk diffusion assay for in vitro susceptibility testing of omadacycline, a new antibiotic for the treatment of community-acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infections (ABSSSI).

    • August 8, 2022: The FDA cleared the VITEK 2 AST- Gram Positive Telavancin (≤0.015 - ≥ µg/mL) (K212243), a miniaturized, abbreviated and automated version of the doubling dilution technique for determining the minimum inhibitory concentration of telavancin, an antibiotic used for the treatment of complicated skin and skin structure infections (cSSSI) and hospital-acquired and ventilator-associated bacterial pneumonia (HABP/VABP).

    • July 12, 2022: The FDA cleared the VITEK 2 AST-Yeast Caspofungin (≤0.125 - ≥8 µg/mL) (K213899), a miniaturized, abbreviated and automated version of the classic broth dilution method to determine the minimum inhibitory concentration of caspofungin, an antifungal agent with updated breakpoints for testing Candida spp.

    • June 3, 2022: The FDA cleared the VITEK 2 AST-Gram Negative Omadacycline (≤0.25 - ≥16 µg/mL) (K213931), a miniaturized, abbreviated and automated version of the classic broth dilution method to determine the minimum inhibitory concentration of omadacycline, a new antibiotic for the treatment of community-acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infections (ABSSSI).

    • April 29, 2022: The FDA granted the De Novo request for the BioFire Joint Infection (JI) Panel (DEN200066), a multiplexed nucleic-acid-based, in vitro diagnostic test intended for the simultaneous qualitative detection and identification of multiple bacterial and yeast nucleic acids and select antimicrobial resistance genes from synovial fluid obtained from individuals suspected to have a joint infection. 

    • April 27, 2022: The FDA cleared the EPlex Blood Culture Identification Gram Negative (BCID-GN) Panel (K213236), a multiplexed nucleic acid test intended for simultaneous qualitative detection and identification of multiple potentially pathogenic gram-negative bacterial organisms and select determinants associated with antimicrobial resistance, as well as detect several gram-positive bacteria and several Candida species all from positive blood culture. Claims were added to include the detection of nucleic acids from additional strains of E. coli, Citrobacter, Enterococcus, and Pseudomonas aeruginosa.

    • April 14, 2022: The FDA cleared the VITEK 2 AST-Gram Negative Ciprofloxacin (≤0.06 - ≥4 µg/mL) (K214023), a miniaturized, abbreviated and automated version of the classic broth dilution method to determine the minimum inhibitory concentration of ciprofloxacin, an antibiotic with updated breakpoints for testing Enterobacterales and P. aeruginosa.

    • February 25, 2022: The FDA cleared the VITEK 2 AST-Yeast Fluconazole (≤0.5 - ≥64 µg/mL) (K213241), a miniaturized, abbreviated and automated version of the classic broth dilution method to determine the minimum inhibitory concentration of fluconazole, an antifungal agent with updated breakpoints for testing Candida albicans, Candida parapsilosis, and Candida tropicalis.

    • February 4, 2022: The FDA cleared the VITEK 2 AST-Gram Positive Linezolid (≤0.5 - ≥8 µg/mL) (K212849), a miniaturized, abbreviated and automated version of the classic broth dilution method to determine the minimum inhibitory concentration of linezolid, an antibiotic with updated breakpoints for testing Staphylococcus species

    • December 20, 2021:The FDA cleared the Sensititre 18-24 Hour MIC or Breakpoint Susceptibility System with Cefiderocol in the Dilution Range of 0.03-64 µg/mL (K203741), a miniaturized version of the classic broth dilution method to determine the minimum inhibitory concentration of Cefiderocol with additional indicated species (Acinetobacter baumannii and Serratia marcescens) and using updated breakpoints for members of the Enterobacterales order.

    • December 15, 2021:The FDA cleared the Sensititre YeastOne Susceptibility System with Voriconazole in the Dilution Range of 0.008 - 8 μg/mL (K211539), a micro-version of the broth dilution susceptibility test performed in multi-well microtiter plates to determine the minimum inhibitory concentration of voriconazole, an antifungal agent with new breakpoints and indications for testing Candida species.

    • November 12, 2021: The FDA cleared the ETEST Fosfomycin (FO) (0.032-512 µg/mL) (K210757), a gradient diffusion assay to determine the minimum inhibitory concentration of Fosfomycin, an antibiotic used for the treatment of urinary tract infection.

    • October 28, 2021: The FDA cleared the APAS Independence with IC Chromogenic MRSA BD Analysis Module and the APAS Independence with IC Chromogenic MRSA TFS/S Analysis Module (K200839), an in vitro diagnostic test system for the automated assessment of microbial colonies on chromogenic culture media to aid in screening for methicillin-resistant Staphylococcus aureus (MRSA).

    • October 28, 2021: The FDA cleared the VITEK 2 AST- Streptococcus Cefotaxime (≤0.125 - ≥8 µg/mL) (K210287), an abbreviated and automated version of a broth microdilution assay to determine the minimum inhibitory concentration of Cefotaxime with Streptococcus species.

    • October 27, 2021: The FDA cleared the Thermo Scientific Oxoid Lefamulin Disc (20µg) LMU20 (K210873), a disk diffusion assay for in vitro susceptibility testing of Lefamulin, a first-in-class antibiotic for the treatment of community-acquired bacterial pneumonia. 

    • October 20, 2021: The FDA cleared the MTS Piperacillin-Tazobactam 0.016/4 - 256/4 µg/mL (K211672), a gradient diffusion assay to determine the minimum inhibitory concentration of Piperacillin-Tazobactam, a combination antibiotic that is used to treat various bacterial infections.

    • September 30, 2021: The FDA cleared the Acuitas AMR Gene Panel (K191288), a qualitative nucleic acid-based, highly multiplexed in vitro diagnostic test for the simultaneous detection and identification of 28 genetic determinants of resistance to 8 antibiotic groups (aminoglycosides, carbapenems, cephalosporins, fluoroquinolones, penicillins, sulfonamides, trimethoprim, vancomycin) among 19 organism species for a total of 117 unique organism/gene combinations being reported. The Acuitas AMR Gene Panel includes an extension of the device labeling (electronic user guide) that provides additional supporting information about performance characteristics and interpretation of genetic determinants associated with antimicrobial resistance for the Acuitas AMR Gene Panel.
    • September 14, 2021: The FDA cleared the VITEK 2 AST-Gram Positive Fosfomycin (≤8 - ≥256 µg/mL) (K202396), an abbreviated and automated version of a broth microdilution assay to determine the minimum inhibitory concentration of Fosfomycin, an antibiotic used for the treatment of urinary tract infection.
    • July 30, 2021: The FDA cleared the Thermo Scientific Oxoid Cefiderocol Disc (30ug) FDC30 (K203700), a disk diffusion assay for in vitro susceptibility testing of Cefiderocol, a newer antibiotic for the treatment of complicated urinary tract infection.
    • July 23, 2021: The FDA cleared the Sensititre 20-24 hour Haemophilus influenzae /Streptococcus pneumoniae MIC or Breakpoint, Susceptibility System with Autoread Dtest (containing erythromycin at 1 ug/mL and clindamycin at 0.5 ug/mL) (K202612), a miniaturized version of the classic broth dilution method that can provide both qualitative and quantitative susceptibility results from Haemophilus influenza, Streptococcus pneumoniae and Streptococcus species when tested with erythromycin or clindamycin. The Dtest detects for inducible clindamycin resistance in Streptococcus spp. resistant to erythromycin.
    • July 9, 2021: The FDA cleared the VITEK 2 AST-Gram Negative Meropenem (≤0.25 - ≥16 µg/mL) (K201675), an abbreviated and automated version of a broth microdilution assay to determine the minimum inhibitory concentration of Meropenem, an antibiotic for which FDA recently updated interpretive criteria. 

    • June 14, 2021: The FDA cleared the VITEK 2 AST-Gram Negative Imipenem/Relebactam (<0.25/4 - >16/4 µg/mL) (K211136), an abbreviated and automated version of a broth microdilution assay to determine the minimum inhibitory concentration of Imipenem/Relebactam. A claim was added to the previously cleared device to include a new indicated species, Acinetobacter calcoaceticus-baumannii complex.

    • May 27, 2021: The FDA cleared the MicroScan MICroSTREP Plus Panels With Tetracycline (0.06-16 µg/mL) (K202423), an abbreviated version of a broth microdilution assay to determine the minimum inhibitory concentration of Tetracycline with aerobic streptococci. Performance data was updated to include reanalysis of MIC results for Streptococcus pneumoniae with tetracycline using currently recognized interpretive criteria.

    • November 16, 2020:  MicroScan Dried Gram-Negative MIC/Combo Panels with Ceftazidime (Caz) (0.5-64 μg/mL) (K202343), an abbreviated version of a broth microdilution assay to determine the minimum inhibitory concentration of Ceftazidime, a antibacterial used to treat lower respiratory tract infections, skin and skin-structure infections, bacterial septicemia, bone and joint infections, gynecologic infections, intra-abdominal infections and central nervous system infections

    • September 28, 2020: VITEK 2 AST-Gram Negative Ceftazidime (≤0.5 - ≥32 µg/mL) (K193299) an abbreviated and automated version of a broth microdilution assay to determine the minimum inhibitory concentration of Ceftazidime, a antibacterial used to treat lower respiratory tract infections, skin and skin-structure infections, bacterial septicemia, bone and joint infections, gynecologic infections, intra-abdominal infections and central nervous system infections.

    • September 15, 2020: Accelerate Pheno System, Accelerate PhenoTest BC Kit  (K192665) a multiplexed in vitro diagnostic test utilizing both qualitative nucleic acid fluorescence in situ hybridization (FISH) identification and quantitative antimicrobial susceptibility methods directly from positive blood culture samples. Claims were added for antimicrobial susceptibility testing of Pseudomonas aeruginosa with ceftazidime, cefepime, meropenem, piperacillin/tazobactam, and aztreonam. 

    • June 29, 2020: Addition of Acinetobacter spp. for testing with the MicroScan Dried Gram-Negative MIC/Combo Panels with Meropenem (Mer) (0.004 - 32 µg/mL) (K201423), an abbreviated version of a broth microdilution assay to determine the minimum inhibitory concentration of Meropenem, an antibiotic for which FDA recently updated the susceptibility test interpretive criteria on the STIC website to include interpretive criteria when testing this organism group.

    • May 7, 2020: ETEST Plazomicin (0.016 - 256 µg/mL) (K200512) a gradient diffusion assay to determine the minimum inhibitory concentration of Plazomicin, an antibiotic for the treatment of complicated urinary tract infection

    • April 28, 2020: VITEK 2 AST-Gram Positive Delafloxacin (≤0.015 - ≥1 µg/mL) (K200590) an abbreviated and automated version of a broth microdilution assay to determine the minimum inhibitory concentration of Delafloxacin, an antibiotic approved for the treatment of community-acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infections (ABSSSI)

    • April 6, 2020: MTS Lefamulin 0.016 - 256 µg/mL (K200308) a gradient diffusion assay to determine the minimum inhibitory concentration of Lefamulin, a first-in-class antibiotic for the treatment of community-acquired bacterial pneumonia.

    • March 20, 2020: MTS Omadacycline 0.002 - 32 µg/mL (K200180) a gradient diffusion assay to determine the minimum inhibitory concentration of Omadacycline, a new antibiotic for the treatment of community-acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infections (ABSSSI).

    • March 18, 2020: MicroScan Dried Gram Negative MIC/Combo Panels with Ciprofloxacin (Cp) (0.004 - 8 µg/mL) (K193536) an abbreviated version of a broth microdilution assay to determine the minimum inhibitory concentration of Ciprofloxacin, an antibiotic for which FDA recently recognized revised interpretive criteria and published those on the FDA STIC webpage.

    • March 18, 2020: BioFire Blood Culture Identification 2 (BCID2) Panel (K193519) a multiplexed nucleic acid-based test for the detection and identification of multiple bacterial and yeast nucleic acids and select genetic determinants associated with antimicrobial resistance direct from positive blood culture samples.

    • March 13, 2020: VITEK 2 AST-Gram Negative Imipenem/Relebactam (≤0.25/4 - ≥16/4 µg/mL) (K193572) abbreviated and automated version of a broth microdilution assay to determine the minimum inhibitory concentration of Imipenem/Relebactam, an antibiotic approved eight months ago for the treatment of complicated urinary tract infections and complicated intra-abdominal infections.

    • March 12, 2020: Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Cefiderocol in the dilution range of 0.03-64 µg/mL (K193538) an abbreviated and automated version of a broth microdilution assay to determine the minimum inhibitory concentration Cefiderocol, an antibiotic approved four months ago for the treatment of complicated urinary tract infections.
    • March 3, 2020: MicroScan Dried Gram-Negative MIC/Combo Panels with Levofloxacin (Lvx) (0.008 - 16 µg/mL) (K193358) an abbreviated version of a broth microdilution assay to determine the minimum inhibitory concentration of Levofloxacin, an antibiotic for which FDA recently recognized revised interpretive criteria and published those on the FDA STIC webpage.
    • January 8, 2020: Sensititre 20-24 hour Haemophilus influenzae/Streptococcus Pneumoniae MIC or Breakpoint Susceptibility System with Lefamulin in the dilution range of 0.008 – 16 µg/mL (K193024) a broth-microdilution assay that was cleared shortly after new drug approval for Lefamulin, a first-in-class antibiotic for the treatment of community-acquired bacterial pneumonia.
    • January 23, 2020: HardyDisk AST Cefiderocol 30µg (FDC30) (K193504) a disk diffusion assay that was the first AST device for Cefiderocol, an antibiotic for the treatment of complicated urinary tract infection. This device was cleared just eight weeks after new drug approval.
    • December 20, 2019: The FDA recently cleared the Unyvero LRT BAL Application (K191967), a multiplex molecular test for the detection and identification of nucleic acid sequences from 20 bacterial/fungal pathogens and 10 antibiotic resistance markers to aid in the diagnosis of pneumonia. It is the first multiplexed pneumonia panel that identifies Pneumocystis jirovecii, a leading cause of pneumonia in immunocompromised patients.
    • December 5, 2019: FDA authorizes marketing of diagnostic test that uses novel technology to detect MRSA bacteria - The FDA authorized marketing of a new diagnostic test based on bacterial viability and novel technology to detect Methicillin-resistant Staphylococcus aureus (MRSA) bacterial colonization, a widespread cause of hospital-acquired infections. The cobas vivoDx MRSA diagnostic test may allow health care professionals to evaluate patients for colonization with MRSA bacteria more quickly than traditional culture-based techniques when such testing is needed.
    • November 26, 2019: The FDA cleared the AST device bioMerieux ETEST Delafloxacin (DFX) 0.002-32 μg/mL (K192738) a gradient diffusion assay for testing Delafloxacin
    • November 14, 2019: The FDA cleared the AST device MicroScan Dried Gram Negative MIC/Combo Panels with Meropenem (Mer) (0.004-32 µg/mL) (K192355) a broth-microdilution assay for testing Meropenem.
    • November 6, 2019: The FDA recently cleared AST devices for testing newly approved antimicrobial agents:
    • October 31, 2019: The FDA cleared the AST device MTS Ampicillin-Sulbactam 0.016/0.008 – 256/128 µg/mL (K192345) a gradient diffusion assay for testing Ampicillin-Sulbactam.
    • October 2, 2019: The FDA cleared NG Test CARBA 5 (K191889), the first rapid lateral flow immunochromatographic assay that detects and differentiates between five common types of carbapenemase enzymes (KPC, OXA, NDM, VIM, IMP). The assay tests pure colonies after growth on solid media, with results obtained in 15 minutes. The test is intended as an aid infection control.
    • September 25, 2019: The FDA cleared ARIES MRSA assay (K191742), another nucleic acid amplification test (NAAT) for MRSA detection from nasal swabs. This and similar assays are used as an aid in the prevention and control of MRSA infections in healthcare settings.

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Antimicrobial stewardship

The FDA works closely with domestic and international partners to promote the judicious use of antibiotics in the veterinary setting and complements the work done by other government agencies in the human healthcare setting.

On the veterinary side, the FDA’s Center for Veterinary Medicine (CVM) is responsible for:

  • Ensuring that animal drugs are safe and effective for their approved conditions of use, and
  • Playing an active role in coordinating the development and implementation of regulations and policies pertaining to antimicrobial drugs intended for use in animals, including food-producing animals.

CVM’s activities to advance antimicrobial stewardship are further detailed in CVM’s plan, Supporting Antimicrobial Stewardship in Veterinary Settings: Goals for Fiscal Years 2019-2023 (PDF, 282 KB). Also see: FDA Antimicrobial Stewardship in Animals: Stakeholder Resources and FDA-TRACK: Progress on FDA’s Support of Antimicrobial Stewardship in Veterinary Settings

On the human healthcare side, the FDA supports policies and regulations designed to preserve the effectiveness of antimicrobials for human use. This includes:

  • Working to ensure the labeling of antimicrobial drugs intended for use in humans contain required statements regarding appropriate use
  • Providing recommendations on scientifically sound clinical trial designs to evaluate human drugs to help inform appropriate use and stewardship efforts
  • Maintaining the FDA-Recognized Antimicrobial Susceptibility Test Interpretive Criteria webpage
  • Working with diagnostic manufacturers and academia on developing biomarkers to rapidly identify whether a patient’s symptoms are due to a bacterial infection, or when antibiotics can be stopped during treatment
  • Promoting flexible regulatory approaches to rapid identification of bacterial pathogens, thereby allowing targeted antibiotic treatment and reducing broad-spectrum antibiotic use

Also see from CDER: Combating Antibiotic Resistance

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Surveillance and monitoring of antimicrobial use and resistance

The FDA works in close coordination with interagency partners and domestic stakeholders to collect the data necessary to conduct surveillance and monitoring of antimicrobial use and resistance.

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Regulatory science

The FDA supports regulatory science to develop the tools, standards, and approaches to facilitate the translation of breakthrough discoveries in science and technology into innovative, safe, and effective medical products.

The 2021: Advancing Regulatory Science at FDA: Focus Areas of Regulatory Science (FARS) report outlines topics FDA has identified as needing continued targeted investment in regulatory science research to facilitate development of innovative products, provide data and methods to inform regulatory decision-making, and improve guidance to sponsors. Antimicrobial resistance is a priority area, under the focus area “Public Health Preparedness and Response.” Please contact FARS@fda.hhs.gov with questions about this initiative.

Tools for scientists

Community stakeholders: We need your samples

As part of our effort to address the global health challenge of AMR, the FDA supports the development of next-generation sequencing (NGS)-based diagnostics to help healthcare providers identify and treat the right pathogen. To help build NGS infrastructure, our FDA-ARGOS database makes publicly available quality-controlled microbial reference genomes for diagnostic use. The FDA team is looking for unique, hard-to-source microbes like biothreat organisms, emerging pathogens, and AMR-related pathogens to help improve the database. We encourage the community to share microbe samples.

Image: A lab worker in the CDC-FDA AR Isolate Bank (Credit: CDC)

The Center for Drug Evaluation and Research

  • CDER's Office of Antimicrobial Products research activities include facilitating the development of new antibacterial drugs to treat patients and advancing the science of clinical trial design.

  • Exploiting Real-World Data to Optimize the Use of Antibiotics - Through the National Action Plan for Combating Antibiotic-Resistant Bacteria (CARB) (PDF, 370KB - research summary published Nov. 2021), FDA's Center for Drug Evaluation and Research (CDER) has supported research at Johns Hopkins University School of Medicine to help us use the data in electronic health records to better understand the association between varying durations of antibiotic therapy and patient outcomes. These two research studies demonstrated the feasibility and advantages of a novel automated approach for extracting patient-level data from electronic health records to capture treatment outcomes in diverse real-world health care settings. The results provide valuable evidence to inform best practices related to the duration of antibiotic treatment in diverse bacterial infections, optimizing patient outcomes while reducing the risk for antimicrobial resistance.

The Center for Biologics and Evaluation and Research

The National Center for Toxicological Research’s Microbiology Division

Center for Veterinary Medicine 

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FDA publications

Guidance documents, compliance policy guides, and other FDA publications represent the FDA's current thinking on a topic. Documents related to antimicrobial resistance in humans and animals include guidances on developing products for treatment, prevention, and diagnosis of bacterial infections. You can also find information for the animal and veterinary industry on collection of sales and distribution of antimicrobial products, and veterinary feed directives.

You can search the entire database of FDA guidance documents by keyword, or visit the industry pages below for more information.

For information about FDA-recognized antimicrobial susceptibility test interpretive criteria, visit http://www.fda.gov/STIC, and the corresponding Notice of Updates.

  • In November 2023, the FDA issued a proposed rule to classify certain wound dressings and wound washes that contain antimicrobials and other chemicals, based on the level of antimicrobial resistance concern. The proposed classification for these wound dressings and liquid wound washes is intended to be split into two classifications: while most of these products are proposed to be classified into class II (subject to special controls, in combination with general controls, and requiring a premarket notification), those products that contain a medically important antimicrobial are proposed to be classified into class III (requiring a PMA to provide a reasonable assurance of safety and effectiveness, as detailed in the accompanying proposed order). Electronic or written comments should be submitted by February 28, 2024, to ensure the FDA considers comments before it begins work on the final rule and final order. 
  • In September 2023, the FDA issued “Antimicrobial Susceptibility Test (AST) System Devices–Updating Breakpoints in Device Labeling” as an immediately-in-effect guidance. This guidance is intended to provide industry and FDA staff with information regarding updating susceptibility test interpretive criteria (STIC)/breakpoints and associated performance data in device labeling for antimicrobial susceptibility test (AST) system devices.
  • In May 2023, the FDA launched a new web page, Antimicrobial Resistance and Medical Devices, to explain how antimicrobial susceptibility test devices are intended to help health care providers identify the correct therapy (antimicrobial agent) to treat specific bacterial or fungal infections and help identify drug-resistant infections for patient care. Antimicrobial susceptibility testing devices sold in the U.S. for use in clinical laboratories must be reviewed and cleared by the FDA’s Center for Devices and Radiological Health (CDRH).
  • 510(k) Premarket Notification and de novo databases – provide information on all in vitro diagnostic devices cleared or granted since November 2003, including devices that detect antibiotic resistance markers, phenotypic antimicrobial susceptibility devices, and biomarkers used to aid in patient management
  • Part of the FDA's strategic approach for combatting antimicrobial resistance involves providing guidance that aims to facilitate the availability of antimicrobial susceptibility tests in a timely manner once a new antibacterial drug is approved. On January 17, 2019, the FDA published a new guidance for industry, Coordinated Development of Antimicrobial Drugs and Antimicrobial Susceptibility Test Devices (PDF, 438 KB). The goal of this guidance is to minimize time between the approval of new antimicrobial drugs and clearance of antimicrobial susceptibility tests used to determine the potential effectiveness of those drugs; and provide recommendations to the medical device and drug industries on how to work together to facilitate timely clearance of antimicrobial susceptibility test devices by the FDA. The FDA will discuss this final guidance at a webinar scheduled for February 12, 2019. (Federal Register notice)

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Information for consumers

FDA consumer updates

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Press and statements

  • October 10, 2024: The FDA announced the publication of the 2023 Summary Report on Antimicrobials Sold or Distributed for Use in Food-Producing Animals. The 2023 data indicate that U.S. sales and distribution of medically important antimicrobial drugs approved for use in food-producing animals decreased by 2% between 2022 and 2023; this represents a 37% decrease in sales since the sales peaked in 2015.

  • September 25, 2024: The FDA announced it is awarding funds for three projects to collect, analyze and report data on antimicrobial use (AMU) in animals. These projects support long term AMU data collection efforts under development within the U.S, including proposed public-private partnership frameworks for tracking AMU data.

  • July 15, 2024: The FDA authorized marketing of DiaSorin Molecular LLC’s Simplexa C. auris Direct, a molecular-based assay intended to detect Candida auris (C. auris) DNA from a skin swab of the armpit or groin from patients suspected of C. auris colonization. The test is intended to help prevent and control C. auris infections in health care settings. The assay may allow health care professionals to evaluate patients for colonization with C. auris faster than traditional culture-based techniques when such testing is needed. Faster detection can help stop the spread of this organism, which is frequently resistant to multiple antifungal drugs and can cause serious infections in hospitalized patients. Test results are meant to be used in conjunction with other clinical, epidemiologic, and laboratory information available to the clinician evaluating the patient. The test is not intended to diagnose or monitor treatment for C. auris infection. This is the latest example of the FDA’s ongoing commitment to helping ensure the development and expansion of tests for emerging infectious pathogens.

  • June 21, 2024: The FDA converted Sirturo (bedaquiline) to traditional approval following a determination that a confirmatory trial verified clinical benefit. Sirturo is indicated for pulmonary tuberculosis (TB) due to Mycobacterium tuberculosis resistant to at least rifampin and isoniazid, also known as multi-drug resistant tuberculosis (MDR-TB), as part of a combination therapy, for adults and pediatric patients (5 years and older, weighing at least 15 kg). Sirturo was first approved in December 2012 under the FDA’s Accelerated Approval pathway. As part of the initial approval, the FDA required the applicant to conduct a confirmatory clinical study and develop a patient registry to assess rates of serious adverse events. 

  • April 24, 2024: FDA Approves New Treatment for Uncomplicated Urinary Tract Infections - The FDA approved Pivya (pivmecillinam) tablets for the treatment of female adults with uncomplicated urinary tract infections (UTIs) caused by susceptible isolates of Escherichia coli, Proteus mirabilis and Staphylococcus saprophyticus. 

  • April 9, 2024: FDA Approves New Antimicrobial Drug for Cattle and Swine - The FDA approved Pradalex (pradofloxacin injection) solution for certain respiratory diseases in cattle and swine. Pradofloxacin is a medically important antimicrobial in the fluoroquinolone class and may only be prescribed by a licensed veterinarian as a single injection. Over the past several decades, FDA has implemented policies to help ensure that medically important antimicrobials approved for use in animals are used in a manner that is consistent with principles of antimicrobial stewardship. For example, all medically important antimicrobials for animals require the authorization of a licensed veterinarian because FDA believes that, given their specialized training and experience, veterinarians play a critical role in antimicrobial stewardship and can help reduce the risks of antimicrobial resistance.

  • April 3, 2024: The FDA approved Zevtera (ceftobiprole medocaril sodium for injection) for the treatment of adults with Staphylococcus aureus bloodstream infections (bacteremia) (SAB), including those with right-sided infective endocarditis; adults with acute bacterial skin and skin structure infections (ABSSSI); and adult and pediatric patients three months to less than 18 years old with community-acquired bacterial pneumonia (CABP). For more information, see the FDA press release: FDA Approves New Antibiotic for Three Different Uses.

  • December 14, 2023: The FDA announced the issuance of nine warning letters to manufacturers and distributors of unapproved antimicrobial drugs for nonfood minor animal species such aquarium fish and pet birds. These products are marketed over the counter without medical oversight, which can contribute to the development of antimicrobial resistance.
  • November 29, 2023: The FDA issued a proposed rule to classify certain wound dressings and wound washes that contain antimicrobials and other chemicals, based on the level of antimicrobial resistance concern. The proposed classification for these wound dressings and liquid wound washes is intended to be split into two classifications: while most of these products are proposed to be classified into class II (subject to special controls, in combination with general controls, and requiring a premarket notification), those products that contain a medically important antimicrobial are proposed to be classified into class III (requiring a PMA to provide a reasonable assurance of safety and effectiveness, as detailed in the accompanying proposed order). Electronic or written comments should be submitted by February 28, 2024, to ensure the FDA considers comments before it begins work on the final rule and final order.
  • November 20, 2023: The FDA Center for Veterinary Medicine published a Perspectives with CVM blog post, CVM Antimicrobial Stewardship in FY 2023 and Beyond, in recognition of 2023 World Antimicrobial Awareness Week (November 18-24). The post highlights what CVM is doing to address antimicrobial resistance and preserve the effectiveness of these critical and life-saving drugs.
  • September 28, 2023: The FDA issued “Antimicrobial Susceptibility Test (AST) System Devices–Updating Breakpoints in Device Labeling” as an immediately-in-effect guidance. This guidance is intended to provide industry and FDA staff with information regarding updating susceptibility test interpretive criteria (STIC)/breakpoints and associated performance data in device labeling for antimicrobial susceptibility test (AST) system devices in response to breakpoint changes posted on the “FDA-Recognized Antimicrobial Susceptibility Test Interpretive Criteria” website (STIC Website). This guidance supersedes Sections II.A and V of FDA Guidance Updating Labeling for Susceptibility Test Information in Systemic Antibacterial Drug Products and Antimicrobial Susceptibility Testing Devices (June 2009). With the publication of the current guidance, the June 2009 guidance has been completely superseded and is being withdrawn.
  • September 25, 2023: The FDA released draft Guidance for Industry (GFI) #273, to provide recommendations on how animal drug sponsors may voluntarily establish a defined duration of use for certain approved medically important antimicrobial animal drugs with indications that currently lack a defined duration of use. The agency is accepting public comments on the draft guidance until December 26, 2023.
  • August 2, 2023: The FDA announced it is seeking public comment on a report generated by the Reagan-Udall Foundation outlining a potential framework for establishing a public-private partnership to collect and analyze antimicrobial use data from food-producing animals. Comments can be submitted to docket FDA-2022-N-0824 through October 31, 2023.
  • June 12, 2023: The FDA announced that Guidance for Industry (GFI) #263 has been fully implemented and all affected animal drug sponsors opted to either voluntarily change the approved marketing status of certain medically important antimicrobial drugs for animals from over-the-counter (OTC) to prescription (Rx) or to voluntarily withdraw approval of their affected OTC animal drug applications. Animal owners and caretakers will still have access to appropriate antimicrobials to address animal health issues by consulting with a licensed veterinarian. The successful implementation of GFI #263 is an encouraging demonstration of the commitment of animal drug sponsors and veterinarians to support the judicious use of antimicrobials in animals.
  • May 23, 2023: FDA Approves New Treatment for Pneumonia Caused by Certain Difficult-to-Treat Bacteria - The FDA approved Xacduro (sulbactam for injection; durlobactam for injection), a new treatment for hospital-acquired bacterial pneumonia (HABP) and ventilator-associated bacterial pneumonia (VABP) caused by susceptible strains of bacteria called Acinetobacter baumannii-calcoaceticus complex, for patients 18 years of age and older. According to the World Health Organization, Acinetobacter species top the list of critical bacterial pathogens that pose the greatest threat to human health, highlighting the high level of need for additional treatment options amid growing global resistance to antimicrobial medicines.

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Events

The following is a list of select recent and upcoming AMR-related events involving the FDA.

  • April 17, 2023: Antimicrobial Drugs Advisory Committee meeting (virtual) - The committee met in open session to discuss new drug application (NDA) 216974, for sulbactam-durlobactam for injection, submitted by Entasis Therapeutics, Inc. The applicant's proposed indication was for the treatment of infections due to Acinetobacter baumannii-calcoaceticus complex including multidrug-resistant and carbapenem-resistant strains.

  • February 9, 2023: FDA Grand Rounds: A Modular Approach for Enhanced Plasmid Subtyping and AMR Gene Profiling of Plasmids (webcast, 12:00 - 1:00 p.m. ET) - Plasmids are a major factor in the spread of antimicrobial resistance genes. Current plasmid typing methods do not account for the great degree of genetic diversity associated with the recombination mechanisms that allow plasmids to acquire antimicrobial resistance genes. In this presentation by Lucas Harrison, Ph.D., FDA Center for Veterinary Medicine (CVM), we introduce an enhanced plasmid subtyping method that not only identifies the genetic elements exclusive to and indicative of a plasmid type, but also characterizes plasmids based on the DNA sequence and relative position of these genetic elements as they are rearranged through plasmid recombination mechanisms. 

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Interagency collaboration to address AMR

FDA participates in and contributes to Combating Antibiotic-Resistant Bacteria (CARB), a Government-wide effort launched in 2014, including the work of:

The FDA’s Office of Public Health Strategy and Analysis (OPHSA) coordinates the FDA’s involvement in CARB and represents the FDA on PACCARB.  Based on consultation with and input from the FDA’s Centers, OPHSA routinely updates HHS on the FDA’s progress in meeting National Action Plan goals, objectives, and milestones. 

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Contact the FDA

Consumers and general information: contact FDA
You may also call 1-888-INFO-FDA / (1-888-463-6332)

Report a fraudulent product
Includes options for phone and online reporting

Press: contact the Office of Media Affairs
Email fdaoma@fda.hhs.gov or call 301-796-4540

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