COVID-19 updates from FDA: First point-of-care antibody test for COVID-19 | New patient outreach toolkit

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Coronavirus Disease 2019 (COVID-19) updates

Actions by the FDA in our ongoing response to the COVID-19 pandemic since our last MCMi email update include: September 29, 2020: A Closer Look at the FDA’s Center for Devices and Radiological Health’s Unprecedented Efforts in the COVID-19 Response September 25, 2020: Daily Roundup - FDA issues an updated summary of the agency’s COVID-19 response efforts September 24, 2020: FDA published a Patient Outreach Toolkit for health care professionals, with useful COVID-19 resources to share with your patients and others in your community  September 23, 2020: FDA Authorizes First Point-of-Care Antibody Test for COVID-19 September 23, 2020: COVID-19: An Update on the Federal Response - Hearing before the Senate Committee on Health, Education, Labor and Pensions; FDA Commissioner Stephen M. Hahn, M.D., testified  Bookmark www.fda.gov/coronavirus for the latest.

A closer look at the FDA’s Center for Devices and Radiological Health’s unprecedented efforts in the COVID-19 response

By: Stephen M. Hahn, M.D., Commissioner of Food and Drugs

If you want to know the FDA’s impact on COVID-19, look no further than the numbers. In a few short months, the agency’s Center for Devices and Radiological Health’s (CDRH) response to the pandemic has been unprecedented in terms of volume, speed, and agility – spanning multiple areas, including: regulatory flexibility, Emergency Use Authorizations (EUAs) for devices, shortage mitigation activities, Public Health Service Corps deployment, and extensive engagement with stakeholders. Additionally, over 50 percent of CDRH employees have dedicated an incredible number of hours to the COVID-19 response, in addition to performing their existing responsibilities at the FDA. (September 29, 2020)
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Patient outreach toolkit

FDA developed new health education materials tailored for diverse consumers, available in English and Spanish. Health care professionals can use the materials to talk with patients about COVID-19 health fraud, vaccine development, testing, and other aspects of FDA’s response. (September 24, 2020)  View the toolkit

Emergency Use Authorization (EUA) updates

FDA authorizes first point-of-care antibody test for COVID-19 FDA issued an EUA for the first serology (antibody) point-of-care (POC) test for COVID-19. The Assure COVID-19 IgG/IgM Rapid Test Device was first authorized for emergency use by certain labs in July 2020 to help identify individuals with antibodies to SARS-CoV-2, indicating recent or prior COVID-19 infection. That EUA was reissued (PDF) to authorize the test for POC use using fingerstick blood samples. This authorization means that fingerstick blood samples can now be tested in POC settings like doctor’s offices, hospitals, urgent care centers and emergency rooms rather than having to be sent to a central lab for testing. (September 23, 2020)  Updated evidence to support the emergency use of COVID-19 Convalescent Plasma FDA posted a document summarizing updated evidence to support the emergency use of COVID-19 Convalescent Plasma (PDF). The agency will continue to review the circumstances and appropriateness of the authorization for emergency use. To make this information accessible to the public, the document posted on the web presents FDA’s review in relatively plain language. (September 23, 2020)  FDA revokes umbrella EUA for infusion pumps and infusion pump accessories The FDA revoked the umbrella EUA for infusion pumps and infusion pump accessories for use by health care providers issued on May 13, 2020. To date, no device had been added to the appendix of this umbrella EUA. The FDA has determined that circumstances support revocation, and that individual EUAs will allow for tailored indications and scopes of authorization. Accordingly, the FDA has decided to revoke the umbrella EUA. Instead, the FDA may issue individual EUAs for infusion pumps and infusion pump accessories that meet the requisite EUA statutory criteria.(September 23, 2020)  Diagnostic test EUAs As of today, 257 tests are authorized by FDA under EUAs; these include 205 molecular tests, 48 antibody tests, and 4 antigen tests Also see: Coronavirus Testing Basics

Events

• Today! September 30, 2020: Virtual Town Hall Series - Immediately in Effect Guidance on Coronavirus (COVID-19) Diagnostic Tests - FDA will host a virtual Town Hall for clinical laboratories and commercial manufacturers that are developing or have developed diagnostic tests for SAR-CoV-2, 12:15 p.m. - 1:15 p.m. ET. FDA will host additional town halls in this series on Wednesdays in September. To ensure you are connected, please dial-in at 12:00 p.m.
• October 2, 2020: Vaccines and Related Biological Products Advisory Committee (webcast) - The committee will meet to discuss and make recommendations on selection of strains to be included in an influenza virus vaccine for the 2021 Southern Hemisphere influenza season, which is part of FDA’s year-round efforts to flight flu, along with other public health partners like CDC and NIH.
• October 13, 2020: Save the date for the next event in FDA's webinar series to share information and answer your questions on respirators and other personal protective equipment (PPE). Printable slides and transcripts from previous events in this series are available.
• October 22, 2020: Vaccines and Related Biological Products Advisory Committee (webcast) - The committee will meet to discuss, in general, the development, authorization, and/or licensure of vaccines to prevent COVID-19. No specific application will be discussed at this meeting.

Information for industry

Medical devices

• The FDA added one new device to the Device Discontinuance List on the Medical Device Shortages During the COVID-19 Public Health Emergency web page. There are no updates to the Device Shortage List. Since the web page was first published, the FDA also updated the web page to clarify how we determine what devices are in shortage, as well as how the analysis informs other measures the FDA uses to help address the public health emergency, including issuing EUAs and providing enforcement discretion for products that play an important role in meeting demand, as well as working with other federal partners. The FDA will continue to update the lists as the COVID-19 public health emergency evolves. (September 24, 2020) 

The FDA is committed to providing timely recommendations, regulatory information, guidance, and technical assistance necessary to support rapid COVID-19 response efforts. FDA has issued more than 60 COVID-19-related guidances to date.

In case you missed it

List of hand sanitizers consumers should not use Some hand sanitizers have been recalled and there are more than 175 hand sanitizers the FDA recommends you stop using right away. Bookmark www.fda.gov/handsanitizerlist for the latest, and use our step-by-step search guide to find out if your product is on the list.

FDA's COVID-19 response at-a-glance Take a look at recent FDA actions, and find quick links to more information in our FDA COVID-19 Response At-A-Glance Summary. (updated September 25, 2020)

COVID-19 resources for health professionals Find information about medical products FDA has authorized for emergency use, frequently asked questions about personal protective equipment (PPE), a new Patient Outreach Toolkit, and more.

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FDA Medical Countermeasures Initiative (MCMi) News)