Contacts for Medical Devices During the COVID-19 Pandemic
March 24, 2023 - The FDA has finalized two guidances: Transition Plan for Medical Devices That Fall Within Enforcement Policies Issued During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency and Transition Plan for Medical Devices Issued Emergency Use Authorizations (EUAs) Related to Coronavirus Disease 2019 (COVID-19). The guidances outline the FDA's general recommendations to transition from certain policies adopted and operations implemented during the COVID-19 pandemic to normal operations, including the FDA's recommendations for:
- Developing a transition implementation plan,
- Submitting a marketing submission, and
- Taking other actions with respect to these devices.
The FDA encourages stakeholders to review the two final guidances, attend the webinar, and reach out to the FDA if they have questions or concerns. In particular, for manufacturers planning to seek marketing authorization for their devices, the FDA recommends beginning work on a marketing submission, including a transition implementation plan, as described in the guidances.
Additional Resources:
- Transition Plan for Medical Devices That Fall Within Enforcement Policies Issued During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency
- Transition Plan for Medical Devices Issued Emergency Use Authorizations (EUAs) Related to Coronavirus Disease 2019 (COVID-19)
- Webinar on Guidances on COVID-19 Transition Plans for Medical Devices - April 18, 2023
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 Device Availability
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 availability 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" |
| Are a device manufacturer and have questions about the list of device types included in the updated guidance document | CDRHManufacturerShortage@fda.hhs.gov Begin the email subject line with the word "List Question" |
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: |
|---|---|
| COVID-19 Tests | COVID19DX@fda.hhs.gov |
| 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 |
| Viral transport media | COVID19Dx@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).