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.
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|
|Gowns and other apparel||CDRH-COVID19-PPE@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|
|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).