Coronavirus (COVID-19) and Medical Devices
On this page:
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Info on specific devices
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For all devices
Emergency Use Authorizations (EUAs) for Medical Devices During COVID-19
EUAs for in vitro diagnostic tests, personal protective equipment (PPE), and more.
Contacts for Medical Devices During COVID-19
Industry hotline and email addresses for EUAs, device availability, enforcement policies, and more.
CDRH's Response to COVID-19 Infographic
Data visualization for January 1-December 28, 2020
In Vitro Diagnostic Tests: COVID-19 Tests, Including Antibody Tests
For general information:
- Coronavirus Testing Basics
- COVID-19 Tests and Collection Kits Authorized by the FDA in 2020
- FDA’s Ongoing Work to Support and Advance COVID-19 Diagnostic Test Accuracy and Availability
- Pooled Sample Testing and Screening Testing for COVID-19
- Screening for COVID-19: Deciding Which Test to Use When Establishing Testing Programs
- Report: South Korea's Response to COVID-19: Focus on Testing Strategy and Lessons Learned
For test developers (laboratories and manufacturers):
- FAQs on Testing for SARS-CoV-2
- FAQs on Viral Transport Media during COVID-19
- SARS-CoV-2 Reference Panel Comparative Data
For health care providers and clinical laboratory staff:
- SARS-CoV-2 Viral Mutations: Impact on COVID-19 Tests
- Genetic Variants of SARS-CoV-2 May Lead to False Negative Results with Molecular Tests for Detection of SARS-CoV-2 - Letter to Clinical Laboratory Staff and Health Care Providers
- Certain COVID-19 Serology/Antibody Tests Should Not Be Used
- Transport Media Safety Risk - Use Compatible Transport Media with SARS-CoV-2 Tests that Use Bleach
- 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
- Potential for False Positive Results with Antigen Tests for Rapid Detection of SARS-CoV-2 - Letter to Clinical Laboratory Staff and Health Care Providers
- Potential for False Positive Results with Abbott Molecular Inc. Alinity m SARS-CoV-2 AMP and Alinity m Resp-4-Plex AMP Kits - Letter to Clinical Laboratory Staff and Health Care Providers
Information on antibody (serology) tests:
- Antibody (Serology) Testing for COVID-19: Information for Patients and Consumers
- FDA Fact sheet - Antibody Test Oversight and Use for COVID-19 (PDF)
- EUA Authorized Serology Test Performance
Guidances:
- Policy for Evaluating Impact of Viral Mutations on COVID-19 Tests - Guidance for Test Developers and Food and Drug Administration Staff
- Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency (Revised) - Immediately in Effect Guidance for Clinical Laboratories, Commercial Manufacturers, and Food and Drug Administration Staff
- Enforcement Policy for Viral Transport Media During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency
- Enforcement Policy for Modifications to FDA Cleared Molecular Influenza and RSV Tests During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency - Guidance for Industry and Food and Drug Administration Staff
Masks and Respirators
For general information:
- Face Masks, Including Surgical Masks, and Respirators for COVID-19
- Wear Face Masks with No Metal During MRI Exams: FDA Safety Communication
Flowcharts:
- Considerations for Selecting Respirators for Your Health Care Facility
- Manufacturing and Distributing Respirators for Health Care Use in the United States During the COVID-19 Pandemic
Information on respirators and respirator EUAs
- Non-NIOSH Approved Respirator EUA FAQ
- FAQs for Filtering Facepiece Respirator (FFR) Decontamination Systems
Information on respirators for health care professionals:
- Use the Correct Cycle and Compatible N95 Respirators When Decontaminating Respirators with STERRAD Sterilization Systems
- Certain Filtering Facepiece Respirators from China May Not Provide Adequate Respiratory Protection
- Risk of Misinterpreting Hydrogen Peroxide Indicator Colors for Vapor Sterilization
Other information for health care professionals:
Guidance:
- Enforcement Policy for Face Masks and Respirators During the Coronavirus Disease (COVID-19) Public Health Emergency (Updated 5/26/20)
Gloves, Gowns, and Other Personal Protective Equipment (PPE)
For general information:
For health care professionals:
- Medical Glove Conservation Strategies
- Surgical Mask and Gown Conservation Strategies
- Strategies for Optimizing the Supply of Eye Protection
Guidance:
Ventilators and Ventilator Accessories
For general information:
For health care professionals:
- Ventilator Supply Mitigation Strategies
- Using Ventilator Splitters During the COVID-19 Pandemic - Letter to Health Care Providers
- Ventilators and Ventilator Accessories EUAs
Guidance:
Other Medical Devices and Topics
Guidance documents are documents issued by the FDA that describe the agency's interpretation of or policy on a regulatory issue. The title of the guidance often indicates the intended audiences for the guidance, such as industry (medical device manufacturers and distributors), clinical laboratories, and FDA staff.
To address the COVID-19 public health emergency, the FDA has determined that prior public participation for the following guidance documents is not feasible or appropriate. Accordingly, the FDA issued these guidances without prior public comment.
These guidance documents are immediately in effect, but they remain subject to public comment in accordance with the FDA's good guidance practices.