• 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. 
• Experts from the FDA’s Center for Biologics Evaluation and Research provide advice to academic investigators and sponsors through the Initial Targeted Engagement for Regulatory Advice on CBER Products (INTERACT), which can help streamline product development and approval.
• 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:

• Bacteriophages (viruses that infect, replicate within, and ultimately destroy bacteria)
• Live biotherapeutic products (LBP) (biological products that 1) contain live organisms, such as bacteria; 2) are applicable to the prevention, treatment, or cure of a disease or condition of human beings; and 3) are not a vaccine)
  • Also see from CBER: Early Clinical Trials with Live Biotherapeutic Products: Chemistry, Manufacturing, and Control Information (Guidance for Industry) (PDF,  174 KB) 
• Microbiome therapies (e.g., fecal microbiota for transplantation (FMT))
  • Also see from CBER: Regulatory Considerations for Fecal Microbiota Transplantation Products.  Cell Host &Microbe 27:173-175, 2020; DOI 10.1016/j.chom.2020.01.018
• Immune-modulators

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

• Also see from CBER: General Principles for the Development of Vaccines to Protect Against Global Infectious Diseases (Guidance for Industry) (PDF, 58 KB)

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.

• 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.

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.

• September 30, 2021: 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: 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: 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: 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: 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: 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.

• 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: 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 - 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: 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: 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: FDA recently cleared AST devices for testing newly approved antimicrobial agents:
  • HardyDisk AST Lefamulin 20µg (LMU20) (K192326) a disk diffusion assay for testing Lefamulin (September 19, 2019)
  • ETEST Eravacycline (ERV) (0.002 – 32 Μg/ML) (K192050) a gradient diffusion assay for testing Eravacycline (September 29, 2019)
  • Sensititre 18-24 Hour MIC Or Breakpoint Susceptibility System With Imipenem-Relebactam In The Dilution Range Of 0.03/4-256/4 Ug/ML (K192250) a broth-microdilution assay for testing Imipenem-Relebactam. (October 16, 2019) This device was evaluated under the auspices of the coordinated development guidance (issued on February 1, 2019) which aims at achieving timely availability of AST devices.
  • AST device Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Lefamulin in the dilution range of 0.008 – 16 µg/mL (K192729) a broth-microdilution assay that was cleared just 80 days after new drug approval for Lefamulin, a first-in-class antibiotic for the treatment of community-acquired bacterial pneumonia. (November 6, 2019)
• October 31, 2019: 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: 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: 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.