| Date Published | Source | Title/Link/Description |
| 11/9/23 |
FDA
| |
| 3/6/23 |
FDA
| |
| 2/24/23 |
FDA
| |
| 1/5/23 |
NIH
| |
| 12/28/22 |
CDC
| |
| 9/27/22 |
FDA
|
FDA Updates COVID-19 Test Policy, Encourages Developers to Seek Traditional Premarket Review for Most Test Types
|
| 5/16/22 |
FDA
|
FDA Authorizes First COVID-19 Test Available without a Prescription That Also Detects Flu and RSV
|
| 3/8/22 |
HHS
| |
| 3/1/22 |
FDA
|
Do Not Use Certain Celltrion DiaTrust COVID-19 Tests
|
| 3/1/22 |
FDA
|
Do Not Use Certain ACON Flowflex COVID-19 Tests
|
| 3/1/22 |
FDA
|
Do Not Use SD Biosensor STANDARD Q COVID-19 Ag Home Tests
|
| 10/4/21 |
FDA
| |
| 7/22/21 |
HHS
| |
| 5/27/21 |
HHS
| |
| 5/25/21 |
HHS
| |
| 5/19/21 |
FDA
|
FDA Safety Communication: Antibody Testing Is Not Currently Recommended to Assess Immunity After COVID-19 Vaccination
|
| 3/31/21 |
FDA
| |
| 3/16/21 |
FDA
|
Screening for COVID-19: Deciding Which Test to Use When Establishing Testing Programs
|
| 2/26/21 |
DOL; Dept. of Treasury
| |
| 3/1/21 | FDA | |
| 2/9/21 | FDA |
Using Ventilator Splitters During the COVID-19 Pandemic – Letter to Health Care Providers
|
| 1/4/21 | FDA |
Risk of False Results with the Curative SARS-Cov-2 Test for COVID-19: FDA Safety Communication
|
| 12/16/20 | FDA | |
| 12/11/20 | CDC |
COVID-19 Vaccination Communication Toolkit
|
| 12/11/20 | CDC | |
| 12/11/20 | CDC | |
| 12/9/20 | FDA | |
| 11/24/20 | FDA | |
| 11/23/20 | CDC |
Strategies for Optimizing the Supply of Facemasks
|
| 11/19/20 | FDA | |
| 11/17/20 | FDA | |
| 11/17/20 | GAO | |
| 11/17/20 | FDA | |
| 11/16/20 | NIH | |
| 11/10/20 | AMA | |
| 11/10/20 | CMS | |
| 11/10/20 | Eli Lilly, FDA | |
| 11/10/20 | Eli Lilly | |
| 11/10/20 | FDA | |
| 11/10/20 | HHS, DoD | |
| 11/9/20 | FDA | |
| 11/4/20 | HHS, DoD | |
| 11/3/20 | FDA |
Potential for False Positive Results with Antigen Tests for Rapid Detection of SARS-CoV-2 – Letter to Clinical Laboratory Staff and Health Care Providers
|
| 11/2/20 | HHS, DoD | |
| 11/2/20 | CDC |
Centralized National Reporting Mechanism for COVID-19 Laboratory Tests Results and Other Reportable Conditions, United States
|
| 10/31/20 | HHS |
389,000 BinaxNOW COVID-19 Tests Distributed Thus Far to Historically Black Colleges and Universities
|
| 10/22/20 | FDA | |
| 10/15/20 | CMS | |
| 10/9/20 | CMS | |
| 10/7/20 | FDA |
Recommendations on Providing Clear Instructions to Patients Who Self-Collect an Anterior Nares (Nasal) Sample in a Health Care Setting for SARS-CoV-2 Testing – Letter to Health Care Providers
|
| 10/6/20 | NIH | |
| 10/6/20 | CMS | |
| 10/1/20 | HHS |
Remdesivir Now Available Directly from Distributor
|
| 9/25/20 | CMS | |
| 9/18/20 | CDC |
Updated: Overview of Testing for SARS-CoV-2 (COVID-19) (asymptomatic persons)
|
| 9/1/20 | FDA |
Stop Using Gowns, including Surgical Gowns, from Laws of Motion PPE – Letter to Health Care Providers
|
| 8/28/20 | FDA | |
| 8/26/20 | FDA | |
| 8/24/20 | FDA |
Pooled Sample Testing and Screening Testing for COVID-19
|
| 8/23/20 | FDA | |
| 8/19/20 | FDA |
Manufacturing, Supply Chain, and Drug and Biological Product Inspections During COVID-19 Public Health Emergency Questions and Answers
|
| 8/18/20 | FDA |
Considerations for Selecting Respirators for Your Health Care Facility
|
| 8/16/20 | CDC |
Interim Guidance for Rapid Antigen Testing for SARS-CoV-2
|
| 8/15/20 | FDA | FDA Issues Emergency Use Authorization to Yale School of Public Health for SalivaDirect, Which Uses a New Method of Saliva Sample Processing |
| 8/11/20 | HHS |
HHS Invests in Diagnostic Labs to Expand COVID-19 Testing Capacity in the United States
|
| 8/10/20 | HHS | COVID-19 State Testing Plans (July-December) |
| 8/8/20 | CDC |
COVID-19 Electronic Laboratory Reporting Implementation by State
|
| 8/5/20 | FDA | |
| 8/1/20 | CDC |
Interim Guidance for Use of Pooling Procedures in SARS-CoV-2 Diagnostic, Screening, and Surveillance Testing
|
| 7/30/20 | FDA | |
| 7/29/20 | HHS | |
| 7/23/20 | FDA |
Testing Supply Substitution Strategies – UPDATED
|
| 7/17/20 | CDC |
Updated Interim Guidance, Criteria for Return to Work for Healthcare Personnel with SARS-CoV-2 Infection
|
| 7/17/20 | CDC |
Updated Interim Guidance, Discontinuation of Transmission-Based Precautions and Disposition of Patients with COVID-19 in Healthcare Settings
|
| 7/17/20 | CDC |
Duration of Isolation and Precautions for Adults with COVID-19 (Decision Memo)
|
| 7/10/20 | HHS | |
| 7/7/20 | HHS |
‘Surge’ COVID-19 Testing in Hotspot Jurisdictions in Florida, Louisiana and Texas
|
| 7/6/20 | FDA |
False Positive Results with BD SARS-CoV-2 Reagents for the BD Max System
|
| 7/6/20 | CDC |
Guidance for General Laboratory Safety Practices during the COVID-19 Pandemic
|
| 7/4/20 | CDC |
Frequently Asked Questions about Coronavirus (COVID-19) for Laboratories
|
| 7/3/20 | CDC |
Information for Laboratories about Coronavirus (COVID-19)
|
| 7/2/20 | CDC |
Interim Guidance on Testing Healthcare Personnel for SARS-CoV-2
|
| 7/2/20 | FDA | |
| 6/27/20 | CDC |
Standardized Procedure for Broad-based Testing for SARS-CoV-2 in Congregate Settings
|
| 6/16/20 | FDA | |
| 6/12/20 | CDC | |
| 6/12/20 | FDA | |
| 6/7/20 | FDA | |
| 6/4/20 | HHS |
Frequently Asked Questions: Laboratory Data Reporting for COVID-19 Testing
|
| 6/4/20 | HHS |
COVID-19 Laboratory Data Reporting: CARES Act Section 18115
|
| 5/27/20 | FDA | |
| 5/24/20 | CDC |
Interim Guidelines for COVID-19 Antibody Testing
|
| 5/17/20 | CDC |
CDC Seroprevalence Survey Types
|
| 5/17/20 | CDC |
COVID-19 Serology Surveillance Strategy
|
| 5/17/20 | CDC |
How to Get CDC’s COVID-19 Diagnostic Test and Supplies
|
|
5/16/20
| FDA | Coronavirus (COVID-19) Update: FDA Authorizes First Standalone At-Home Sample Collection Kit That Can Be Used With Certain Authorized Tests |
|
5/12/20
| CMS | Price Transparency: Requirements for Providers to Make Public Cash Prices for COVID-19 Diagnostic Testing |
| 5/11/20 | White House | White House Fact Sheet on Testing |
| 5/11/20 | CDC |
CDC Activities and Initiatives Supporting the COVID-19 Response and the President’s Plan for Opening America Up Again
|
| 5/11/20 | FDA | FAQs on Testing for SARS-CoV-2 – Updated |
| 5/8/20 | CMS | Medicare Pharmacies and Other Suppliers May Temporarily Enroll as Independent Clinical Diagnostic Laboratories |
| 5/4/20 | FDA | Policy for Coronavirus Disease-2019 tests During the Public Health Emergency (Revised) |
| 5/1/20 | FDA | Coronavirus (COVID-19) Update: FDA Issues Emergency Use Authorization for Potential COVID-19 Treatment |
| 5/1/20 | FDA | Fact Sheet for Patients and Parent/Caregivers: Emergency Use Authorization (EUA) of Remdesivir for Coronavirus Disease 2019 (COVID-19) |
| 5/1/20 | FDA | Fact Sheet For Health Care Providers: Emergency Use Authorization (EUA) of Remdesivir |
| 4/30/20 | CMS | Interim Final Rule: Medicare and Medicare, Additional Policy and Regulatory Revisions in Response to the COVID-19 Public Health Emergency |
| 4/30/20 | CMS | Updated COVID-19 Emergency Declaration Blanket Waivers for Health Care Providers |
| 4/27/20 | CDC |
Updated Evaluating and Testing Persons for COVID-19
|
| 4/20/20 | CDC |
Support for States, Tribes, Localities and Territories: Resources to get and keep America open
|
| 4/14/20 | CDC | |
| 4/14/20 | CMS | |
| 4/12/20 | FDA | Coronavirus (COVID-19) Update: FDA Issues Emergency Use Authorization to Decontaminate Millions of N95 Respirators |
| 4/11/20 | CMS | Trump Administration Announces Expanded Coverage for Essential Diagnostic Services Amid COVID-19 Public Health Emergency |
| 4/8/20 | FEMA | FEMA COVID-19 Supply Chain Task Force: Supply Chain Stabilization |
| 4/8/20 | FDA | FAQs on Shortages of Surgical Masks and Gowns |
| 4/8/20 | OSHA | |
| 4/7/20 | FEMA | |
| 4/3/20 | RWJF | COVID-19 Scenario Generation Tool |
| 4/1/20 | CDC |
Decontamination and Reuse of Filtering Facepiece Respirators
|
| 3/31/20 | White House | Delegation of Certain Functions and Authorities under the National Defense Authorization Act for Fiscal Year 2020 |
| 3/31/20 | FDA | Current Shortages of Hydroxychloroquine and Chloroquine |
| 3/31/20 | FDA | Warning Letter: Bioactive C60/FullerLifeC60 LLC |
| 3/31/20 | FDA | Warning Letter: Halosense Inc. |
| 3/31/20 | FDA | Coronavirus Treatment Acceleration Program (CTAP) |
| 3/31/20 | FDA | Coronavirus (COVID-19) Update: FDA Continues to Accelerate Development of Novel Therapies for COVID-19 |
| 3/31/20 | HHS | Optimizing Ventilator Use during the COVID-19 Pandemic |
| 3/30/20 | FDA | FDA on Signing of the COVID-19 Emergency Relief Bill, Including Landmark Over-the-Counter Drug Reform and User Fee Legislation |
| 3/30/20 | HHS | HHS Accelerates Clinical Trials, Prepares for Manufacturing of COVID-19 Vaccines |
| 3/30/20 | FDA | Enforcement Policy for Gowns, Other Apparel, and Gloves During the Coronavirus Disease (COVID-19) Public Health Emergency |
| 3/30/20 | FDA | FDA Updates COVID-19 EUA Information for the QIAstat-Dx Respiratory SARS-CoV-2 Panel |
| 3/30/20 | FDA | FDA Updates COVID-19 EUA Information for NeuMoDx SARS-CoV-2 Assay from NeuMoDx Molecular, Inc. |
| 3/30/20 | FDA | Coronavirus (COVID-19) Update: FDA expedites review of diagnostic tests to combat COVID-19 |
| 3/30/20 | FDA | JRB Enterprise Group Inc. DBA Anti Aging Bed |
| 3/30/20 | HHS | Secretary Azar Statement on FDA Authorization of Mask Sterilization Procedure |
| 3/29/20 | White House | Remarks by President Trump in a Meeting with Supply Chain Distributors on COVID-19 |
| 3/29/20 | HHS | HHS accepts donations of medicine to Strategic National Stockpile as possible treatments of COVID-19 patients |
| 3/28/20 | FDA | Coronavirus (COVID-19) Update: FDA Takes further steps to help mitigate supply interruptions of food and medical products |
| 3/27/20 | FDA | Notifying FDA of a Permanent Discontinuance of Interruptions in Manufacturing Under Section 506C of the FD&C Act Guidance for Industry |
| 3/27/20 | FDA | Coronavirus (COVID-19) Update: FDA takes action to help increase U.S. supply of ventilators and respirators for protection of health care workers, patients |
| 3/27/20 | FDA | FDA Updates COVID-19 EUA Information for NcTAG CoV Extended Panel Assay from Luminex Molecular Diagnostics |
| 3/27/20 | FDA | FDA Updates COVID-19 EUA Information for ID NOW COVID-19 from Abbott Diagnostics |
| 3/27/20 | DEA | Exception to Regulations Emergency Oral CII Prescription |
| 3/26/20 | CMS | Clinical Laboratory Improvement Amendments (CLIA) Laboratory Guidance During COVID-19 Public Health Emergency |
| 3/26/20 | FDA | FAQs on 3D Printing of Medical Devices, Accessories, Components, and Parts During the COVID-19 Pandemic |
| 3/26/20 | FDA | FAQs on Diagnostic Testing for SARS-CoV-2 – UPDATED |
| 3/26/20 | FDA | FDA Updates COVID-19 EUA Information for Real-Time Fluorescent RT-PCR Kit for Detecting SARS-2019-nCoV |
| 3/25/20 | FDA | Enforcment Policy for Face Masks and Respirators During the Coronavirus Disease (COVID-19) Public Health Emergency |
| 3/25/20 | FDA | Enforcement Policy for Face Masks and Respirators During the Coronavirus Disease (COVID-19) Public Health Emergency |
| 3/25/20 | DEA | DEA State Reciprocity |
| 3/25/20 | FDA | FDA Updates COVID-19 EUA Information for AvellinoCoV2 Test |
| 3/24/20 | FDA | Coronavirus (COVID-19) Update: FDA Takes action to increase U.S. supplies through instructions for PPE and device manufacturers |
| 3/24/20 | FDA | Beware of Fraudulent Coronavirus Tests, Vaccines and Treatments |
| 3/24/20 | FDA | FDA Updates COVID-19 EUA Information for PerkinElmer New Coronavirus Nucleic Acid Detection Kit |
| 3/24/20 | HHS | Emergency Use Authorization Declaration |
| 3/24/20 | CMS | FAQs on Prescription Drugs and the Coronavirus Disease 2019 (COVID-19) for Issuers Offering Health Insurance Coverage in the Individual and Small Group Markets |
| 3/24/20 | FDA | Temporary Policy for Manufacturer of Alcohol for Incorporation Into Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19) Guidance for Industry |
| 3/24/20 | FDA | Investigational COVID-19 Convalescent Plasma – Emergency INDs |
| 3/23/20 | OIG | A Message from HHS OIG Leadership on COVID-19 Fraud |
| 3/23/20 | FDA | FDA Updates COVID-19 EUA Information for Mesa Biotech Inc. Diagnostic Test |
| 3/23/20 | FDA | FDA Updates COVID-19 EUA Information for BioFire Defense, LLC Diagnostic Test |
| 3/23/20 | FDA | FAQs on Diagnostic Testing for SARS-CoV-2 |
| 3/21/20 | FDA | Coronavirus (COVID-19) Update: FDA Issues first Emergency Use Authorization for Point of Care Diagnostic |
| 3/20/20 | FDA | Guidance for Industry: Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19) |
| 3/20/20 | DEA | DEA’s response to COVID-19: DEA is protecting the nation’s prescription drug supply chain |
| 3/20/20 | FDA | Coronavirus (COVID-19) Update: FDA Alerts Consumers About Unauthorized Fraudulent COVID-19 Test Kits |
| 3/18/20 | HHS | HHS Supports Mesa Biotech to Develop a Rapid Diagnostic to Detect Novel Coronavirus Infections |
| 3/16/20 | FDA | Coronavirus (COVID-19) Update: FDA Provides More Regulatory Relief During Outbreak, Continues to Help Expedite Availability of Diagnostics |
| 3/16/20 | FDA | Coronavirus (COVID-19) Update: FDA Issues Diagnostic Emergency Use Authorization to Hologic and LabCorp |
| 3/13/20 | FDA | Coronavirus (COVID-19) Update: FDA gives flexibility to New York State Department of Health, FDA issues Emergency Use Authorization diagnostic |
| 3/13/20 | FDA | Coronavirus (COVID-19) Update: FDA Issues Emergency Use Authorization to Thermo Fisher |
| 3/13/20 | CMS | Medicare Administrative Contractor (MAC) COVID-19 Test Pricing (PDF) |
| 3/12/20 | FDA | Coronavirus (COVID-19) Update: FDA gives flexibility to New York State Department of Health, FDA issues Emergency Use Authorization diagnostic |
| 3/7/20 | FDA | Coronavirus (COVID-19) Update: White House Press Briefing by FDA Commissioner Stephen M. Hahn, M.D. |
| 3/5/20 | CMS | CMS Develops Additional Code for Coronavirus Lab Tests |
| 3/1/20 | Lee Health | Provider Testing Algorithm |
| 2/29/20 | FDA | Emergency Use Authorization to two public health laboratories in New York |
| 2/29/20 | FDA | Coronavirus (COVID-19) Update: FDA Issues New Policy to Help Expedite Availability of Diagnostics |
| 2/13/20 | CMS | Public Health News Alert: CMS Develops New Code for Coronavirus Lab Test |
| 2/6/20 | CMS | Notification to Surveyors of the Authorization for Emergency Use of the CDC 2019-Novel Coronavirus (2019-nCoV) Real-Time RT-PCR Diagnostic Panel Assay and Guidance for Authorized Laboratories |