The .gov means it’s official. Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.
The site is secure. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.
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.
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:
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.
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 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.
FDA encourages the development of novel in vitro diagnostic (IVD) devices for detection of AMR associated with microbial pathogens.
When searching for AMR-related device approvals it is helpful to know the associated Product Code for the class of AMR-related devices.
Recently cleared IVD devices, including Antimicrobial Susceptibility Test (AST) devices, include:
June 3, 2022: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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.
June 14, 2021: 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: 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.
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:
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-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:
Also see from CDER: Combating Antibiotic 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.
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.
As part of our effort to address the global health challenge of AMR, 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
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
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.
November 9, 2021: Exploiting Real-World Data to Optimize the Use of Antibiotics
October 2021: FDA CDER Office of Infectious Diseases CARB Research Overview Fiscal Years 2016-2021 (PDF, 370 KB)
July 5, 2022: FDA Announces 2022 Public Meeting of the National Antimicrobial Resistance Monitoring System - FDA, in cooperation with the U.S. Centers for Disease Control and Prevention and the U.S. Department of Agriculture’s Food Safety and Inspection Service, its partners in the National Antimicrobial Resistance Monitoring System (NARMS), opened registration for the 2022 Public Meeting of NARMS. The meeting will take place virtually on September 21 and 22, 2022, and is open to all stakeholders at no cost.
June 30, 2022: FDA’s Center for Veterinary Medicine released both a status update (PDF, 273 KB) on Phase I of its five-year action plan for Supporting Antimicrobial Stewardship in Veterinary Settings as well as a report (PDF, 12.8 MB) to describe some of the data that FDA and federal partners collect regarding antimicrobial sales, use, and resistance in U.S. animal agriculture and the related food chain.
May 23, 2022: FDA announced the availability of a report drafted by the Reagan-Udall Foundation as part of a cooperative agreement. The report, “Exploring the Potential for A Public-Private Partnership to Support the Tracking and Monitoring of Antimicrobial Use in Food-Producing Animals,” summarizes key findings from a series of targeted conversations with stakeholders about the feasibility of establishing a voluntary public-private partnership to collect and analyze antimicrobial use data from food-producing animals. The Foundation will host a virtual public forum on June 14, 2022, from 1:00 p.m. to 3:00 p.m. to present insights from the report and allow for questions from the public. Registration is now open. The FDA has also opened a docket to accept public comments through August 21, 2022.
February 15, 2022: FDA’s Center for Veterinary Medicine (CVM) released a request for public comments about antimicrobial use in companion animals (e.g., cats, dogs, horses) and the potential impact of this use on antimicrobial resistance in both animals and people. The Federal Register notice includes specific questions for commenters to consider. CVM intends to use the information collected to help develop strategies to further promote antimicrobial stewardship in companion animals. Comments are due by September 14, 2022 (deadline extended).
November 23, 2021: FDA Approves First Treatment for Common Type of Post-Transplant Infection that is Resistant to Other Drugs - FDA approved Livtencity (maribavir) as the first drug for treating adults and pediatric patients (12 years of age and older and weighing at least 35 kilograms) with post-transplant cytomegalovirus (CMV) infection/disease that does not respond (with or without genetic mutations that cause resistance) to available antiviral treatment for CMV. Livtencity works by preventing the activity of human cytomegalovirus enzyme pUL97, thus blocking virus replication.
November 18, 2021: FDA approved an abbreviated new drug application for vancomycin hydrochloride for injection, indicated to treat serious or severe infections caused by susceptible strains of methicillin-resistant (β-lactam-resistant) staphylococci. It is indicated for penicillin-allergic patients, for patients who cannot receive or who have failed to respond to other drugs, including the penicillins or cephalosporins, and for infections caused by vancomycin-susceptible organisms that are resistant to other antimicrobial drugs. The side effects of Vancomycin Hydrochloride for injection include diarrhea, hypotension (low blood pressure), acute kidney injury, and ototoxicity (damage to the ear).
The following is a list of select recent and upcoming AMR-related events involving the FDA.
FDA participates in and contributes to Combating Antibiotic-Resistant Bacteria (CARB), a Government-wide effort launched in 2014, including the work of:
FDA’s Office of Public Health Strategy and Analysis (OPHSA) coordinates FDA’s involvement in CARB and represents FDA on PACCARB. Based on consultation with and input from FDA’s Centers, OPHSA routinely updates HHS on FDA’s progress in meeting National Action Plan goals, objectives, and milestones.
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