Questions for Healthcare Providers and Healthcare Manufacturers
How do I get information on COVID-19 test kits?
- 24/7 Hotline for Diagnostics: If a constituent developer, lab, manufacturer or health care provider has questions about testing or is experiencing spot shortages of testing, personal protective equipment, or other supplies, they should call our toll-free line at 1-888-463-6332 (1-888-INFO-FDA), then choose option (*). The line is available 24 hours a day to help address difficulties obtaining supplies for collecting patient samples for COVID-19 testing, including swabs, media needed for transport, and conservation of the samples – among other things. Please note, however, that FDA does not control the production volume or distribution of medical devices.
- Frequently Asked Questions about COVID-19 Diagnostic Tests: In response to questions from labs, manufacturers, health care providers, and others, FDA has generated FAQs and posted them on our website for all who are involved in test development for COVID-19s. FDA updates these FAQs on a rolling basis, often daily as issues arise. Your constituents can access these FAQs at: https://www.fda.gov/medical-devices/emergency-situations-medical-devices/faqs-diagnostic-testing-sars-cov-2.
- Emergency Use Authorization (EUA) for COVID-19 Diagnostic Tests: If need additional information for completing the EUA template, would like to know how to submit Pre-EUA/EUA submissions to FDA, or wish to consider an alternative specimen type, they may contact the Division of Microbiology Devices at (301) 348-1778 or email CDRH-EUA-Templates@fda.hhs.gov. Please note that FDA is unable to provide information on the status of any individual submissions (this is generally confidential commercial information) and FDA would encourage congressional offices to reach out to specific developers for the status of any pending product submissions.
Other resources for health care providers and professionals:
Personal Protective Equipment:
If you are a health care profession who have questions or is experiencing spot shortages of personal protective equipment or other supplies, they should call our toll-free line at 1-888-463-6332 (1-888-INFO-FDA), then choose option (*). The line is available 24 hours a day to help address difficulties obtaining supplies. Please note, however, that FDA does not control the production volume or distribution of medical devices.
Vaccines and other biological product candidates:
Biological product sponsors, including vaccine developers, wishing to develop vaccines can email email@example.com or call 1-800-835-4709 for further information.
Therapeutics and other drug product candidates:
Sponsors wishing to develop therapeutics are encouraged to submit information and questions via the Pre-IND Consultation program. See https://www.fda.gov/emergency-preparedness-and-response/mcm-issues/covid-19-therapeutics-general-information-interested-stakeholders or call 301-796-1500 for additional information on this program.
Sponsors who have questions regarding the conduct of clinical trials impacted by COVID-19 should contact clinicaltrialconduct-COVID19@fda.hhs.gov
If you are a health care profession who have questions or concerns about a drug shortage, related or unrelated to COVID-19, they should contact CDER’s Division of Drug Information (DDI) at 855-543-3784, 301-796-3400, or firstname.lastname@example.org. Also, FDA's Drug Shortage web page has information related to current shortages.
For those in the food industry who has a question for FDA, they may find information on common questions about food safety and COVID-19 here. If they need to contact FDA’s Center for Food Safety and Applied Nutrition about a COVID-19 related question, they may do so by submitting a question here.
Animal Drugs and Animal Food:
If you has questions or concerns related to COVID-19 and its impact on products regulated by FDA’s Center for Veterinary Medicine, they may contact AskCVM@fda.hhs.gov, and their inquiry will be routed to the appropriate subject matter expert for response. A list of known animal drug shortages is kept by FDA’s Center for Veterinary Medicine.
If you have questions regarding the postponement of inspections under an agreement or contract with the FDA, they should contact OPFeedback@fda.hhs.gov or reach out to their specific project manager. In the meantime, we encourage states currently under contract to please submit their invoices to ensure payment for work completed. We will process their invoices as quickly as possible.
You can find FDA’s COVID-19 FAQ useful in addressing questions related to vaccines, biologics, human tissue products, drugs, medical devices and tests, and food products. We also have specific COVID-19 FAQs for Emergency Use Authorizations, Diagnostic Testing, Food Safety for Industry, Healthcare Professionals, and other specific audiences. These are updated as information becomes available.