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Resources for Healthcare Workers, Labs, Individuals

The U.S. Food and Drug Administration (FDA), Federal Emergency Management Agency (FEMA), and the United States Department of Health and Human Services (HHS) have compiled resources to address these issues. I wanted to provide you with information on additional resources made available for: laboratories and providers that are having difficulties obtaining supplies for COVID-19 testing, including swabs, media needed for transport, and conservation of the samples; entities requiring additional personal protective equipment; healthcare providers with questions or concerns about a drug shortage; and individuals who want to know how they can be of assistance.

COVID-19 Diagnostic Tests 

For questions about development of COVID-19 diagnostic tests:

  • 24/7 Hotline for Diagnostics:  If a 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 the FDA’s 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.
  • For laboratories and providers in VA-01 that are having difficulties obtaining supplies for COVID-19 testing, including swabs, media needed for transport, and conservation of the samples, please use the FDA’s hotline (1-888-INFO-FDA) which is available 24 hours a day. Labs that have questions regarding diagnostic development should email CDRH-EUA-Templates@fda.hhs.gov. Local health departments in need of testing supplies or other materials can call the FDA hotline; they can also work with state officials to make requests of FEMA and ASPR.
  • Emergency Use Authorization (EUA) for COVID-19 Diagnostic Tests:  If you 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, you may contact the Division of Microbiology Devices at (301) 348-1778 or email CDRH-EUA-Templates@fda.hhs.govPlease 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 specific developers to reach out to Congressional offices to notify them of the status of any pending product submissions


 
Personal Protective Equipment (PPE)

If you or a health care provider has questions or is experiencing spot shortages of personal protective equipment or other supplies, you should call FDA’s 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. 

For more information regarding PPE, click here

Gowns: Surgical gowns (including surgical isolation gowns), surgical hoods, and surgical togas are intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, bodily fluids, and particulate material. FDA regulates surgical gowns, surgical isolation gowns, surgical hoods and surgical togas as Class II devices and assesses them for liquid barrier protection among other things.

FDA does not object to your marketing and distribution of the gown and surgical apparel products in the healthcare setting without prior 510(k) clearance if the product is labeled in the following manner:

1) The apparel is not labeled as "surgical”; rather it may be labeled as a “gown”, “toga”, “hood”, etc.
2) It states it may be used when FDA cleared gowns or apparel are unavailable
3) Includes a recommendation against use in a surgical setting or where significant exposure to liquid bodily or other hazardous fluids may be expected.
4) Includes a recommendation against use in a clinical setting where the infection risk level is high;
5) It makes no claims regarding flammability;
6) It makes no claims of antimicrobial or antiviral protection;
7) It makes no claims of infection prevention or reduction;
8) Contains a list of the body contacting materials.

In addition, FDA does not intend to object to marketing of gowns and other surgical apparel that meet the above criteria even if they are manufactured at facilities that do not meet 21 CFR 820.

Masks: Surgical masks provide protection against large droplets, splashes or sprays of bodily or hazardous fluids.  They do not provide the wearer with reliable protection from inhaling smaller airborne particles and are not considered respiratory protection. FDA regulates surgical masks as Class II devices and assesses them for liquid barrier protection among other things.

FDA recognizes the urgent need for face masks in the setting of the COVID-19 pandemic due to increased use and shortages in their availability. FDA does not object to the marketing and distribution of face masks in the healthcare setting without prior 510(k) clearance if the product is labeled in the following manner:

1) It states it may be used when FDA cleared masks are unavailable;
2) It recommends against use in a surgical setting or where significant exposure to liquid bodily or other hazardous fluids may be expected;
3) It makes no claims of antimicrobial or antiviral protection;
4) It makes no claims of infection prevention or reduction;
5) It makes no claims regarding flammability
6) The labeling contains a list of the body contacting materials.
7) The mask is not labeled as a "surgical mask”; rather it may be labeled as a “face mask”

In addition, FDA does not intend to object to marketing of masks that meet the above criteria even if they are manufactured at facilities that do not meet 21 CFR 820.

Medical Countermeasures Development: For businesses that are developing medical countermeasures in response to the COVID-19 outbreak, such as vaccines, therapeutics, and diagnostics, please visit the Biomedical Advanced Research and Development Authority (BARDA) Coronawatch Meeting website, available here. BARDA is particularly interested in products and technologies that have progressed into or beyond non-clinical trials. Submission of materials does not guarantee a meeting or funding from BARDA.

Vaccines and other biological product candidates:  Biological product sponsors, including vaccine developers, wishing to develop vaccines can email industry.biologics@fda.hhs.gov 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.

Clinical Trials:  Sponsors who have questions regarding the conduct of clinical trials impacted by COVID-19 should contact clinicaltrialconduct-COVID19@fda.hhs.gov

Other Business Development: FEMA launched a new website for companies looking to sell or donate medical supplies, equipment or services as part of the COVID-19 response.

Drug Shortages:  If a healthcare provider has 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, ordruginfo@fda.hhs.gov. Also, FDA's Drug Shortage web page has information related to current shortages.  

Food:  If someone in the food industry 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:  For 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.

You may 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. FDA also has specific COVID-19 FAQs forEmergency Use AuthorizationsDiagnostic TestingFood Safety for IndustryHealthcare Professionals, and other specific audiences. These are updated as information becomes available.

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