Coronavirus (COVID-19) and Medical Devices
Contacts for Medical Devices During COVID-19
Industry hotline and email addresses for EUAs, device availability, enforcement policies, and more.
In Vitro Diagnostic Tests: COVID-19 Tests, Including Antibody Tests
For general information:
- Coronavirus Testing Basics
- FDA’s Ongoing Work to Support and Advance COVID-19 Diagnostic Test Accuracy and Availability
For test developers (laboratories and manufacturers):
For health care providers and clinical laboratory staff:
- 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
Information on antibody (serology) tests:
- FDA Fact sheet - Antibody Test Oversight and Use for COVID-19 (PDF)
- EUA Authorized Serology Test Performance
Guidances:
- 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
Masks and Respirators
For general information:
Information on respirator EUAs
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
- Interim Infection Prevention and Control Recommendations for Healthcare Personnel During the Coronavirus Disease 2019 (COVID-19) Pandemic
Guidance:
Ventilators and Ventilator Accessories
For general information:
For health care professionals:
Guidance:
Info on specific devices
Info on specific devices
Emergency Use Authorizations (EUAs) for Medical Devices During COVID-19
EUAs for in vitro diagnostic tests, personal protective equipment (PPE), and more.
Other Medical Devices and Topics
| Device or Topic | Information |
|---|---|
| 3D printing of medical devices | FAQs on 3D Printing of Medical Devices, Accessories, Components, and Parts During the COVID-19 Pandemic |
| Adverse event reporting for medical devices | Adverse Event Reporting for Medical Devices Under Emergency Use Authorization (EUA) or Discussed in COVID-19-Related Guidance Documents |
| Digital health | Digital Health Policies and Public Health Solutions for COVID-19 |
| Glucose meters | FAQs on Home-use Blood Glucose Meters Utilized Within Hospitals During the COVID-19 Pandemic |
| Hospital beds, stretchers, and mattresses | Hospital Beds, Stretchers, and Mattresses During the COVID-19 Pandemic |
| Medical device manufacturing personnel | Protecting the Health and Safety of Medical Device Manufacturing Personnel During COVID-19 |
| Supply chain notifications | |
| Temperature measuring devices | Non-contact Temperature Assessment Devices During the COVID-19 Pandemic |