Historical Information about Device Emergency Use Authorizations
This page is intended to provide reference information on EUAs that were previously issued but no longer in effect, including revoked EUAs. Information about why each EUA was revoked is available in its revocation letter, available in the tables below.
On this page:
- Infusion Pumps
- In Vitro Diagnostics (IVD)
- Personal Protective Equipment (PPE)
- Decontamination Systems for PPE
Infusion Pumps
| Medical Product | Date** | Most Recent Letter of Authorization and Other EUA-Related Information | Fact Sheets and Manufacturer Instructions / Package Insert |
|---|---|---|---|
| Infusion Pumps and Infusion Pump Accessories (umbrella) |
05/13/2020 (issued) 09/21/2020 (revoked) |
Federal Register notices: |
|
In Vitro Diagnostics (IVD)
| Medical Product | Date** | Most Recent Letter of Authorization and Other EUA-Related Information | Fact Sheets and Manufacturer Instructions / Package Insert |
|---|---|---|---|
| ScienCell SARS-CoV-2 Coronavirus Real-time RT-PCR (RT-qPCR) Detection Kit |
04/03/2020 06/05/2020 09/22/2020 06/07/2022 |
|
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| Simoa SARS-CoV-2 N Protein Antigen Test |
01/05/2021 09/10/2021 12/21/2021 05/10/2022 |
|
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| Simoa Semi-Quantitative SARS-CoV-2 IgG Antibody Test |
12/23/2020 04/05/2021 09/23/202 05/10/2022 |
|
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| CRSP SARS-CoV-2 Real-time Reverse Transcriptase (RT)-PCR Diagnostic Assay |
07/08/2020 08/31/2020 10/23/2020 12/18/2020 06/10/2021 09/23/2021 05/05/2022 |
|
|
| Linea COVID-19 Assay Kit |
05/13/2020 07/08/2020 07/30/2020 11/21/2020 07/21/2021 09/23/2021 04/20/2022 |
Federal Register Notice: |
|
| Bio-Rad Reliance SARS-CoV-2/FluA/FluB RT-PCR Assay Kit |
02/11/2021 09/23/2021 04/15/2022 |
Federal Register Notice: |
|
| qSanger-COVID-19 Assay |
09/04/2020 (issued) 06/23/2021 (revised) 09/23/2021 (revised) 03/10/2022 (revoked) |
Federal Register Notice: |
|
| Diagnovital SARS-CoV-2 Real-Time PCR Kit |
06/12/2020 (issued) 09/23/2021 (revised) 03/14/2022 (revoked) |
Federal Register Notice: |
|
| CentoFast-SARS-CoV-2 RT-PCR Assay |
07/01/2020 (issued) 08/13/2021 (revised) 09/23/2021 (revised) 03/17/2022 (revoked) |
Federal Register Notice: |
|
| CentoSure SARS-CoV-2 RT-PCR Assay |
09/29/2020 (issued) 08/13/2021 (revised) 09/23/2021 (revised) 03/17/2022 (revoked) |
Federal Register Notice: |
|
| DiaSorin LIAISON SARS-CoV-2 IgM Assay |
09/29/2020 (issued) 09/23/2021 (revised) 03/15/2022 (revoked) |
Federal Register Notice: |
|
|
BinaxNOW COVID-19 Ag Card 2 Home Test |
03/31/2021 (issued) 09/23/2021 (revised) 01/07/2022 (revised) 02/24/2022 (revoked) |
Federal Register notices: |
|
| Omni COVID-19 Assay by RT-PCR |
06/17/2020 (issued) 12/28/2020 (revised) 09/23/2021 (revised) 02/14/2022 (revoked) |
Federal Register notices: |
|
|
LifeHope 2019-nCoV Real-Time RT-PCR Diagnostic Panel |
06/29/2020 (issued) 09/23/2021 (revised) 02/07/2022 (revoked) |
Federal Register notices: |
|
|
MosaiQ COVID-19 Antibody Magazine |
09/25/2020 (issued) 04/27/2021 (revised) 09/23/2021 (revised) 01/11/2022 (revoked) |
Federal Register notices: |
|
|
BioPlex 2200 SARS-CoV-2 IgG |
07/01/2021 (issued) 09/23/2021 (revised) 01/11/2022 (revoked) |
Federal Register notices: |
|
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Xpert Omni SARS-CoV-2 |
11/27/2020 (issued) 12/23/2020 (revised) 04/20/2021 (reissued) 09/23/2021 (revised) 12/20/2021 (revoked) |
Federal Register notices: |
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ADVIA Centaur SARS-CoV-2 IgG (COV2G) |
07/31/2020 (issued) 09/23/2021 (revised) 12/17/2021 (revoked) |
Federal Register notices: |
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Atellica IM SARS-CoV-2 IgG (COV2G) |
07/31/2020 (issued) 09/23/2021 (revised) 12/17/2021 (revoked) |
Federal Register notices: |
|
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SARS-COV-2 R-GENE |
05/06/2020 (issued) 11/06/2020 (amended) 09/23/2021 (revised) 12/17/2021 (revoked) |
Federal Register notices: |
|
|
qSARS-CoV-2 IgG/IgM Rapid Test |
04/01/2020 (issued) 06/12/2020 (reissued) 09/23/2021 (revised) 12/10/2021 (revoked) |
Federal Register notices: |
|
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BMC-CReM COVID-19 Test |
07/10/2020 (issued) 09/25/2020 (amended) 09/23/2021 (revised) 12/08/2021 (revoked) |
Federal Register notices: |
|
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Akron Children's Hospital SARS-CoV-2 Assay |
09/29/2020 (issued) 09/23/2021 (revised) 12/08/2021 (revoked) |
Federal Register notices: |
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BioGX SARS-CoV-2 Reagents for BD MAX System |
04/02/2020 (issued) 04/07/2020 (amended) 05/29/2020 (amended) 09/25/2020 (amended) 09/23/2021 (revised) 12/08/2021 (revoked) |
Federal Register notices: |
|
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TaqPath COVID-19 MS2 Combo Kit 2.0 |
08/02/2021 (issued) 09/27/2021 (revoked) |
Federal Register notices: |
|
|
Guardant-19 |
08/21/2020 (issued) 12/28/2020 (amended) 08/06/2021 (revoked) |
Federal Register notices: |
|
|
MatMaCorp COVID-19 2SF Test |
12/17/2020 (issued) 08/03/2021 (revoked) |
Federal Register notices: |
[Healthcare] [Patients] [Labeling] |
| Focus Diagnostics Influenza A H1N1 (2009) Real-Time RT-PCR | 12/18/2009 (initial issuance)
06/23/2010 (terminated) |
Federal Register notices: |
[Healthcare] [Patients] [Labeling] |
| Focus Diagnostics Simplexa™ Influenza A H1N1 (2009) Test | 12/18/2009 (initial issuance)
06/23/2010 (terminated) |
Federal Register notices: |
[Healthcare] [Patients] [Labeling] |
| TessArray Resequencing Influenza A Microarray Detection Panel | 12/16/2009 (initial issuance)
06/23/2010 (terminated) |
Federal Register notices: |
[Healthcare] [Patients] [Labeling] |
| GeneSTAT 2009 A/H1N1 Influenza Test | 12/09/2009 (initial issuance)
06/23/2010 (terminated) |
Federal Register notices: |
[Healthcare] [Patients] [Labeling] |
| Roche RealTime ready Influenza A/H1N1 Test | 11/13/2009 (initial issuance)
06/23/2010 (terminated) |
Federal Register notices: |
[Healthcare] [Patients] [Labeling] |
| Prodesse ProFlu-ST Influenza A assay for the diagnosis of 2009 H1N1 Influenza virus infection | 10/27/2009 (initial issuance)
06/23/2010 (terminated) |
Federal Register notices: |
[Healthcare] [Patients] [Labeling] |
| Diatherix 2009 H1N1 Test | 10/09/2009 (initial issuance)
06/23/2010 (terminated) |
Federal Register notices: |
[Healthcare] [Patients] [Labeling] |
| CDC Human Influenza Virus Real-time RT-PCR Detection and Characterization Panel with additional specimens and reagents | 05/02/2009 (initial issuance)
06/23/2010 (terminated) |
Federal Register notices: |
[Healthcare] [Patients] [Labeling] |
Personal Protective Equipment (PPE)
*Note that Secretary's determination and declaration were issued based on revised authorities under the Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 (PAHPRA).
** Date of Authorization or of Latest Amendment
Decontamination Systems for Personal Protective Equipment
| Decontamination System for PPE | Date* | Letter of Authorization |
Fact Sheet |
|---|---|---|---|
| Yale New Haven Health FFR Decontamination System |
01/15/2021 (Issued) 06/30/2021 (Revoked) |
Federal Register notices: |
|
| Ecolab's Bioquell Technology System |
12/04/2020 (Issued) 06/30/2021 (Revoked) |
Federal Register notices: |
|
| Lumin LM3000 Bioburden Reduction UV System |
12/03/2020 (Issued) 06/30/2021 (Revoked) |
Federal Register notices: |
|
| Roxby Development Zoe-Ann Decontamination System | 10/20/2020 (Issued) 06/30/2021 (Revoked) |
Federal Register notices: |
|
| Michigan State University Decontamination System |
07/24/2020 (Issued) 01/21/2021 (Reissued) 06/30/2021 (Revoked) |
Federal Register notices: |
|
| Technical Safety Services VHP Decontamination System |
06/13/2020 (Issued) 01/21/2021 (Reissued) 06/30/2021 (Revoked) |
Federal Register notices: |
|
| Stryker Sustainability Solutions VHP Decontamination System |
05/27/2020 (Issued) 01/21/2021 (Reissued) 06/30/2021 (Revoked) |
Federal Register notices: |
|
| STERIS STEAM Decon Cycle in AMSCO Medium Steam Sterilizers |
05/21/2020 (Issued) 01/21/2021 (Reissued) 06/30/2021 (Revoked) |
Federal Register notices: |
|
| Duke Decontamination System |
05/07/2020 (Issued) 01/21/2021 (Reissued) 06/30/2021 (Revoked) |
Federal Register notices: |
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| Sterilucent, Inc. Sterilization System |
04/20/2020 (Issued) 01/21/2021 (Reissued) 06/30/2021 (Revoked) |
Federal Register notices: |
|
| Stryker STERIZONE VP4 N95 Respirator Decontamination Cycle |
04/15/2020 (Issued) 01/21/2021 (Reissued) 06/30/2021 (Revoked) |
Federal Register notices: |
|
| Advanced Sterilization Products (ASP) STERRAD Sterilization System |
04/11/2020 (Issued) 01/21/2021 (Reissued) 06/30/2021 (Revoked) |
Federal Register notices: |
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| STERIS Sterilization Systems for Decontamination of N95 Respirators |
04/09/2020 (Issued) 01/21/2021 (Reissued) 06/30/2021 (Revoked) |
Federal Register notices: |
|
| Battelle Decontamination System |
03/28/2020 (issued) 03/29/2020 (reissued) 06/06/2020 (reissued) 01/21/2021 (reissued) 04/30/2021 (revoked) |
Additional Information: Federal Register notices: |
|
| Nova2200 for Decontaminating Compatible N95 Respirators (NovaSterilis, Inc.) |
08/20/2020 (issued) 02/12/2021 (revoked) |
Federal Register notices: |
* Date of Authorization or of Latest Amendment
Additional historical information about respirator decontamination EUAs:
- FDA Recommends Transition from Use of Decontaminated Disposable Respirators - Letter to Health Care Personnel and Facilities (04/09/2021)
- Update: FDA No Longer Authorizes Use of Non-NIOSH-Approved or Decontaminated Disposable Respirators - Letter to Health Care Personnel and Facilities (06/30/2021)
- FDA in Brief: FDA Revokes Emergency Use Authorizations for Certain Respirators and Decontamination Systems as Access to N95s Increases Nationwide (06/30/2021)