Medical device

FDA Resources for COVID-19

Resources for device manufacturers to be a part of the managing crisis of 2020.

November 19, 2020
Rory a. carrillo
Principal Consultant

Actions taken by the FDA with regards to the COVID public health emergency

COVID-19 is an infectious disease caused by a novel coronavirus. It is a respiratory illness which can spread from person to person primarily through saliva droplets or discharge from the nose when an infected person coughs or sneezes. Details regarding COVID-19 symptoms, how it spreads and how to protect from the virus are found on the Center for Disease Control and Prevention (CDC) website. 

On February 4, 2020, the HHS Secretary determined that there is a public health emergency involving COVID-19, and subsequently issued declarations justifying the use of EUAs for medical products to prevent, treat and diagnose COVID-191. FDA authorized two different types of tests for COVID-19 like diagnostic tests and antibody tests under the EUA process. Detailed description of tests, steps involved in the testing process and results of the specific test are found in FDA website as “Coronavirus Testing Basics”. List of various tests authorized under the EUA process by FDA can be found in the following link:

Following types of diagnostic, non diagnostic and therapeutic medical devices  are approved under EUA by CDRH for COVID-19: blood purification devices, renal therapy and hemodialysis devices, in vitro diagnostic tests for COVID-19, PPEs, decontamination systems for PPEs, infusion pumps, remote or wearable patient monitoring devices, respiratory assist devices, ventilators and accessories, isolation chambers and face masks4. Emergency Use Authorization of Medical Products and Related Authorities is the guidance document issued in jan 2107 for all stakeholders involved in emergency response activities to provide details regarding criteria for issuance, category of products can apply for EUA, pre EUA activities and submissions, format of EUA submission, conditions of authorization. Templates for these EUA submissions are available on FDA website to help facilitate the preparation, submission, and authorization of an EUA here i am attaching  few templates ventilator EUA interactive templateNon-IVD products, molecular diagnostic template for commercial manufacturers.

Highlights of FDA Activities to support Pandemic:

Ensuring Timely Availability to Accurate and Reliable Tests 

  • To date, the FDA has authorized 175 tests under emergency use authorizations (EUA), which include 145 molecular tests, 28 antibody tests and 2 antigen tests. 
  • The FDA continues to monitor authorized tests and emerging scientific evidence and may revise or revoke an EUA, when appropriate, including when a test’s benefits no longer outweigh its risks.The FDA provides continuous updates to make clear which tests have been issued EUAs by the agency, and which tests should not be used.

Accelerating Availability of Medical Equipment and Products for Treatment 

  • Added more than 88 ventilators and accessories for emergency use to the ventilator EUA and issued EUAs for other equipment to treat patients during COVID-19. 
  • Issued EUAs and policies to help increase the availability of personal protective equipment, such as respirators, gowns, surgical masks, and more. 
  • Monitoring more than 230 active trials of therapeutic agents for COVID-19; another 510 development programs for therapeutic agents are in the planning stages.

Actively Monitoring the Medical Product and Food Supply Chains to Address Imbalances 

  • Continue to screen and monitor millions of domestic and international products in the medical supply chain to help ensure COVID-19-related supplies coming into the U.S. are safe and distributed appropriately.

Halting the Sale of Products with Fraudulent Claims Related to COVID-19 

  • 193 unapproved, uncleared, or unauthorized products that claimed to diagnose, treat, prevent, or cure COVID-19 have been removed from online marketplaces and the FDA has issued 260 abuse complaints to domain name registrars, of which 189 websites have been taken offline. 

Issued 88 health fraud warning letters to sellers of unapproved, uncleared, and unauthorized products with fraudulent COVID-19 claims to diagnose, treat, prevent, or cure COVID-19, including homeopathic drug products, cannabidiol products, nasal sprays, colloidal silver products, herbal products, chlorine dioxide products, antibody tests, and others.

FDA Recent Actions:

  • On July 13, FDA scientists have identified specific areas of the so-called spike proteins on the surface of the COVID-19-casuing virus that appear to be key to triggering strong protective antibody responses in rabbits exposed to the virus. The virus uses one part of the spike protein to attach to a cell and another to fuse with the cell membrane, enabling the virus to infect the cell. The scientists studied antibody response to SARS-CoV-2 spike proteins, which could help inform vaccine design by increasing our understanding of the various triggered antibody responses.
  • FDA has issued emergency use authorizations (EUA) to electroCore, Inc., for its GammaCore Sapphire Non-invasive Vagus Nerve Stimulator and Circadiance, under the umbrella EUA for ventilators, for its SleepWeaver Prevent CPAP Mask that was modified by combining it with an N95.
  • On July 10,  FDA issued a statement in conjunction with preparations to resume domestic inspections, guided by a new risk-assessment system.
  • FDA has issued new Emergency Use Authorizations for diagnostic tests developed by The University of California-San Francisco’s Health Clinical Laboratories-UCSF Clinical Labs at China Basin (for its molecular-based SARS-CoV-2 RNA DETECTR Assay) and BioSewoom, Inc. (for its molecular-based Real-Q 2019-nCoV Detection Kit).
  • On July 07, FDA issued a Letter to Clinical Laboratory Staff and Health Care Providers alerting them of an increased risk of a false positive result with BD SARS-CoV-2 Reagents for the BD Max System test.
  • On July 07, FDA updated the Molecular Diagnostic templates on to provide more detailed recommendations for the validation of assays intended to be used for pooling patient samples.
  • On July 06, FDA Issued Emergency Use Authorization for a COVID-19 Antigen Test
  • On July 06, FDA updated its guidance titled “Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency.” The updated guidance clarifies two previously suggested methods for obtaining informed consent from a hospitalized patient in isolation and clarifies recommendations on documenting details when using video conferencing for trial visits.
  • On July 02, FDA Authorizes Additional COVID-19 Combination Diagnostic Test Ahead of Flu Season by issuing an emergency use authorization (EUA) for the third diagnostic test for detection and differentiation of the viruses that cause flu and COVID-19 in individuals suspected of COVID-19 by their healthcare provider to the U.S. Centers for Disease Control and Prevention (CDC).
  • As part of continued action to protect the American public, the FDA is warning consumers and health care professionals about hand sanitizer products that contain methanol (a.k.a. wood alcohol), a substance often used to create fuel and antifreeze. FDA encourages to report adverse events or quality problems experienced with the use of hand sanitizers to FDA’s MedWatch Adverse Event Reporting program.
  • On July 1, U.S. FDA further supported its effort to evaluate diagnostic tests for COVID-19 by distributing the first round of SARS-CoV-2 reference panel materials. The panel is an independent performance validation step for diagnostic tests of SARS-CoV-2 infection  being used for clinical, not research, purposes. The reference panel can help characterize a test's level of detection and establish relative sensitivity among tests. The FDA panel is available to commercial and laboratory developers who are interacting with the FDA through the pre-emergency use authorization (EUA) process or whose tests have been issued an EUA. The FDA will provide the reference panel to developers at the appropriate stage in the process.
  • To help facilitate the timely development of safe and effective vaccines to prevent COVID-19, on June 30, the FDA provided guidance with recommendations for those developing COVID-19 vaccines for the ultimate purpose of licensure. The guidance, which reflects advice the FDA has been providing over the past several months to companies, researchers, and others, describes the agency’s current recommendations regarding the data needed to facilitate the manufacturing, clinical development, and approval of a COVID-19 vaccine.
  • On June 19, the FDA issued a Letter to Clinical Laboratory Staff and Health Care Providers recommending that they stop using COVID-19 antibody tests that are listed on the FDA’s “removed” test list. The “removed” test list includes tests for which significant clinical performance problems were identified that cannot be or have not been addressed by the commercial manufacturer in a timely manner, tests for which an EUA request has not been submitted by a commercial manufacturer of the serology test within a reasonable period of time as outlined in the FDA’s guidance, and tests voluntarily withdrawn by the respective commercial manufacturers. 

Guidance Documents:

The FDA has issued 57 guidance documents to provide updated policies, transparency, and regulatory flexibility to address the vital medical products and public health issues facing the U.S. during this pandemic. These guidelines are on diagnostics, personal protective equipment, other medical devices, investigational treatment with convalescent plasma, conduct of clinical trials of medical products, blood supply, hand sanitizers, food safety and supply, telemedicine and other topics. Here are the list of guidance documents specifically for medical devices: