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  5. Contacts for Medical Devices During the COVID-19 Pandemic
  1. Emergency Situations (Medical Devices)

Contacts for Medical Devices During the COVID-19 Pandemic

Industry Hotline: Coronavirus COVID-19 Diagnostic Tests and Shortages

For Industry Questions: COVID-19 Diagnostic Tests, and COVID-19 device shortages, including all Personal Protective Equipment for masks and respirators

  • Phone our toll-free line, 1-888-INFO-FDA, and choose option *
    Hours: Monday-Friday: 8:00 a.m.-midnight ET. Weekends and holidays: 8:00 a.m.-8:00 p.m. ET.

Note: The FDA does not:

  • Purchase or distribute medical supplies, such as face masks, respirators, or other medical devices.
  • Maintain a list of suppliers for these devices.
  • Provide specifications for medical devices.

Questions about Emergency Use Authorizations (EUAs)

The FDA has issued EUAs for specific devices for use during the COVID-19 public health emergency. The FDA has specific email addresses for questions on, or for submitting, these EUAs.

If you have a question about: Send email to:
EUAs for in vitro diagnostic tests COVID19DX@fda.hhs.gov
EUAs for other devices, including PPE, respirators, ventilators CDRH-NonDiagnosticEUA-Templates@fda.hhs.gov

Questions about Shortages

The FDA issued a guidance document intended to assist manufacturers in providing timely, informative notifications about changes in the production of certain medical device products that will help the FDA prevent or mitigate shortages of such devices during the COVID-19 public health emergency.

If you: Send email to:
Have general questions about shortages of medical devices DeviceShortages@fda.hhs.gov
Are a device manufacturer and have questions about the guidance document CDRHManufacturerShortage@fda.hhs.gov
Begin the email subject line with the word "Question"
Are a device manufacturer and need to notify the FDA of an interruption or permanent discontinuance in manufacturing CDRHManufacturerShortage@fda.hhs.gov
Begin the email subject line with the word "Notification"

Enforcement Policy Questions

During the COVID-19 public health emergency, the FDA has issued enforcement policies for certain devices. Each enforcement policy lists an FDA email address for questions.

If you have a question about the policy on: Send email to:
Digital health, particularly digital health devices for psychiatric disorders CDRH-COVID19-DigitalHealthForPsychiatricDisorders@fda.hhs.gov
Gloves CDRH-COVID19-PPE@fda.hhs.gov
Gowns and other apparel CDRH-COVID19-PPE@fda.hhs.gov
Infusion pumps CDRH-COVID19-InfusionPumps@fda.hhs.gov
Masks, including surgical masks CDRH-COVID19-SurgicalMasks@fda.hhs.gov
Ophthalmic devices for remote assessment and monitoring CDRH-COVID19-Ophthalmic@fda.hhs.gov
Respirators, including N95 and KN95 respirators CDRH-COVID19-SurgicalMasks@fda.hhs.gov
Sterilizers, disinfectant devices, and purifiers CDRH-COVID19-SterilizersDisinfectantsPurifiers@fda.hhs.gov
Telethermographic systems, including infrared thermographic systems and thermal imaging cameras CDRH-COVID19-Thermography@fda.hhs.gov
Thermometers, including infrared laser and temple devices CDRH-COVID19-Thermometers@fda.hhs.gov
Ventilators and ventilator accessories CDRH-COVID19-Ventilators@fda.hhs.gov

Other Questions

If you have a question about: Send email to:
Importing PPE, including N95 and KN95 respirators COVID19FDAIMPORTINQUIRIES@fda.hhs.gov
3D printing of medical devices or other manufacturing questions COVIDManufacturing@fda.hhs.gov
Fraudulent products, such as COVID-19 test kits and at-home test kits FDA-COVID-19-Fraudulent-Products@fda.hhs.gov

All General Questions

Contact the Division of Industry and Consumer Education (DICE).