FDA is taking action every day to increase the availability of Personal Protective Equipment (PPE) and COVID-19 diagnostic tests, to support the development of therapeutics, and to facilitate remote patient access to healthcare providers. Recent key FDA developments include:
PPE (Personal Protective Equipment)
- Face Masks, Respirators, Gowns, Gloves. FDA hosted a webinar on April 6, 2020 describing its enforcement policy for PPE, including face masks, respirators, gowns, and gloves. The slides can be found here.
FDA does not intend to object to distribution and use (including importation) of the PPE below when the devices are tested and labeled in accordance with FDA’s enforcement policies for face masks/respirators and for gowns/other apparel:
- Face masks: Non-surgical face masks intended for a medical purpose (that are not intended to provide liquid barrier protection); face shields intended for a medical purpose; surgical masks intended to provide liquid barrier protection
- Respirators: Respirators approved under standards in other countries (g., Europe, China, Korea) when FDA-cleared or NIOSH-approved N95 respirators are not available
- Gowns: Non-surgical gowns; gowns with moderate-to-high barrier protection (except Level 4)
- Gloves: Patient examination and surgeon’s gloves
For products meeting the guidance criteria, FDA is waiving regulatory requirements such as registration and listing, good manufacturing practice (GMP), and unique device identification (UDI). PPE that does not meet the criteria in the enforcement policy must submit a request for Emergency Use Authorization (EUA) to FDA or obtain clearance from FDA.
In response to continued respirator shortages, on April 3, FDA issued a new Emergency Use Authorization (EUA) for non-NIOSH-approved respirators made in China, which makes KN95 respirators eligible for authorization if certain criteria are met, including evidence demonstrating that the respirator is authentic.
- SARS-CoV-2 Tests. To date, FDA has issued 31 emergency use authorizationsfor diagnostic tests. FDA has been notified that more than 150 laboratories have begun testing under the policies set forth in FDA’s COVID-19 Policy for Diagnostic Tests for Coronavirus Disease-2019. The guidance allows distribution and use of certain diagnostics tests after validation, but prior to authorization by FDA under an EUA.
- Serological Tests. FDA has authorized one EUA for a serological test that is intended for use by clinical laboratories. Serology tests identify the antibodies (g., IgM, IgG) to SARS-CoV-2. The COVID-19 Policy for Diagnostic Tests for Coronavirus Disease-2019 permits developers of serological tests to market their tests once they have been validated and notification is provided to FDA. Authorization under an EUA is not required for serology tests.
- DTC Tests. COVID-19 diagnostic direct-to-consumer tests are not permitted under the guidance. FDA continues to take action against tests marketed as DTC, and other imported tests that do not meet current FDA guidance.
- COVID-19 Convalescent Plasma. On April 8, FDA issued guidance to provide recommendations to health care providers and investigators on the administration and study of convalescent plasma to patients currently seriously ill with COVID-19. Convalescent plasma is plasma collected from individuals who have recovered from COVID-19. The guidance provides recommendations on pathways available to health care providers for use of investigational COVID-19 convalescent plasma, patient eligibility, and collection of COVID-19 convalescent plasma (including donor eligibility and qualifications).
- Fraudulent Therapies. On April 8, FDA issued a joint warning letter with the Federal Trade Commission (FTC) to three sellers of chlorine dioxide products claiming to treat or prevent COVID-19 in adults and children.
- Expedited Drug Development. On March 31, FDA stood up a new program to expedite the development of potentially safe and effective treatments for COVID-19. Under the program, known as the Coronavirus Treatment Acceleration Program (CTAP), FDA has redeployed medical and regulatory staff to serve on review teams dedicated to COVID-19 therapies and streamlined processes and operations for developers and scientists to send inquiries and requests to FDA. As part of the CTAP, FDA is triaging requests from developers and scientists seeking to develop new drug and biologic therapies, putting the relevant FDA staff in touch with them, and providing interactive input to get studies underway quickly. FDA reports that it is reviewing study protocols within 24 hours in many cases, and has reviewed single-patient expanded access requests within three hours.
- Shortage/National Stockpile. FDA regularly posts updates to its drug shortage webpage, including supplies of hydroxychloroquine and chloroquine. As of March 31, The U.S. Department of Health and Human Services (HHS) had accepted 30 million doses of hydroxychloroquine sulfate to the national stockpile and one million doses of chloroquine phosphate for possible use in treating patients with COVID-19 or for use in clinical trials.
Ventilators, and Other Medical Products
- Ventilators. As of April 7, 21 ventilators and one vent splitter have been authorized under FDA’s EUA program for ventilators, ventilator accessories, and gas anesthesia machines modified for use as ventilators (collectively, “ventilators”). The FDA letter of authorization for ventilators provides the agency’s criteria for safety, performance, and labeling for modified and uncleared ventilators, and waives certain regulatory requirements, such as registration and listing and GMP, for the products. Performance and labeling criteria can be found in Appendix A of the letter, and currently authorized ventilators in Appendix B.
- ECMO Devices. FDA also issued on April 6 a guidance for extracorporeal membrane oxygenation (ECMO) and cardiopulmonary bypass devices to help expand the availability of devices used to treat patients with acute respiratory failure and/or acute cardiopulmonary failure. ECMO devices pump and oxygenate a patient’s blood outside the body, allowing the heart and lungs to rest.
- Ophthalmic Devices. On April 6, FDA issued a guidance for remote ophthalmic assessment and monitoring devices (e.g., visual field devices, ophthalmic cameras) to expand the capability of remote ophthalmic assessment devices to reduce patient and healthcare provider contact during COVID-19.
- Infusion Pumps and Accessories. On April 5, FDA issued an enforcement policy for infusion pumps and accessories to expand their availability and remote capabilities so that safe distances between patients and healthcare providers may be maintained. The policy identifies modifications to FDA-cleared infusion pumps that will not require submission of a premarket notification.
- Clinical Thermometers. FDA issued an enforcement policy for clinical thermometers on April 4 to expand their availability. Fever is a common symptom of COVID-19, and clinical electronic thermometers are a screening tool to assist in the identification of individuals who may be infected. FDA will waive premarket notification, GMP, and other regulatory requirements for thermometers meeting the guidance criteria.
To read more about FDA actions to address COVID-19, click here.
This article is not an unequivocal statement of the law, but instead represents our best interpretation of where things currently stand. This article does not address the potential impacts of the numerous other local, state and federal orders that have been issued in response to the COVID-19 pandemic, but which are not referenced in this article.
*This alert is provided for information purposes only and does not constitute legal advice and is not intended to form an attorney client relationship. Please contact your Sheppard Mullin attorney contact for additional information.*