Contacts for Medical Devices During the COVID-19 Pandemic

The FDA provided guidance for who to contact at FDA regarding COVID-19 issues for medical devices. View the full document here.

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 24 hours a day: 1-888-INFO-FDA, choose option *

Contacts for Medical Devices During the COVID-19 Pandemic | FDA

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[email protected]
EUAs for other devices, including PPE, respirators, ventilators[email protected]

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[email protected]
Are a device manufacturer and have questions about the guidance document[email protected]
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[email protected]
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[email protected]
Gloves[email protected]
Gowns and other apparel[email protected]
Infusion pumps[email protected]
Masks, including surgical masks[email protected]
Ophthalmic devices for remote assessment and monitoring[email protected]
Respirators, including N95 and KN95 respirators[email protected]
Sterilizers, disinfectant devices, and purifiers[email protected]
Telethermographic systems, including infrared thermographic systems and thermal imaging cameras[email protected]
Thermometers, including infrared laser and temple devices[email protected]
Ventilators and ventilator accessories[email protected]

Other Questions

If you have a question about:Send email to:
Importing PPE, including N95 and KN95 respirators[email protected]
3D printing of medical devices or other manufacturing questions[email protected]
Fraudulent products, such as COVID-19 test kits and at-home test kits[email protected]

All General Questions

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

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