As reported earlier here, FDA is taking steps to increase the availability of Personal Protective Equipment (PPE) and COVID-19 diagnostic tests, support the development of therapeutics, and facilitate remote patient access to healthcare providers. Key FDA regulatory developments since our last update include new Emergency Use Authorizations (EUAs) for face shields, N95 respirator decontamination systems, and equipment to treat respiratory failure.
PPE (Personal Protective Equipment)
- Decontamination of N95 Respirators. On April 12, FDA granted an EUA to Advanced Sterilization Products (ASP) for its STERRAD sterilization systems for decontaminating N95 or “N95-equivalent respirators” for re-use by a single user. FDA issued on April 9 a similarly-scoped EUA to STERIS corporation for certain of its sterilizations systems. N95-equivalent respirators include KN95 respirators (China) authorized under the Emergency Use Authorization (EUA) for non-NIOSH-approved respirators made in China and respirators identified in Exhibit 1 of the EUA for imported non-NIOSH approved respirators (which, to date, includes one model from South Africa).
FDA reports that the authorizations will permit the decontamination of potentially four million N95 or N95-equivalent respirators per day for re-use by healthcare professionals.
- KN95 Respirators (China). As previously reported, FDA issued an EUA for non-NIOSH-approved respirators made in China, which made KN95 respirators eligible for authorization if certain criteria are met, including evidence demonstrating that the respirator is authentic. Under the EUA, eligible KN95 respirators (which are not NIOSH approved) must meet one of three criteria, such as marketing authorization in another country or third-party testing to show conformance with performance standards. The updated list of authorized KN95 respirators is here.
- Face Shields. On April 9, FDA issued a letter of authorization for the emergency use of face shields in healthcare settings. Under the EUA, the face shields should include labeling for single or multiple use and instructions for cleaning and/or disinfection (if applicable), may not contain flammable materials (or warn against use near high heat), and may not represent that the shield alone will prevent infection from viruses or microbes. Manufacturers do not need to apply for authorization (as in other EUAs issued during COVID-19). Instead, FDA will notify manufacturers that their shields have been authorized through a public announcement, here. As of April 13, FDA had not posted a list of authorized face shields.
- Face Masks, Respirators, Gowns, Gloves. As reported earlier, 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. According to FDA enforcement policy, the agency does not intend to object to distribution and use (including importation) of certain PPE when labeled and/or tested in accordance with FDA’s enforcement policies for face masks/respirators and for gowns/other apparel.
- SARS-CoV-2 Tests. On April 15, FDA intends to host a virtual Town Hall for clinical laboratories and commercial manufacturers developing diagnostic tests. The meeting is intended to help answer technical questions about the development and validation of tests for SARS-CoV-2. To date, 34 emergency use authorizations have been issued for COVID-19 diagnostic tests.
- 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, but do not diagnose the virus itself. Developers of serological tests may market their tests once they have been validated and notification is provided to FDA.
- DTC tests. FDA has not yet authorized a DTC COVID-19 diagnostic test.
- Chloroquine Phosphate and Hydroxychloroquine. On April 13, FDA announced that it will issue product-specific guidances for chloroquine phosphate and hydroxychloroquine sulfate to support generic drug development for these drugs. Preliminary studies determining the effects of chloroquine and hydroxychloroquine against SARS-CoV-2 (the virus that causes COVD-19) have been promising, and on March 28, FDA authorized the emergency use of the drugs for treatment in certain patients who are hospitalized with COVID-19. FDA currently is prioritizing review of any newly submitted Abbreviated New Drug Applications (ANDAs) for chloroquine phosphate and hydroxychloroquine sulfate
- Fraudulent Therapies: On April 9, FDA and Federal Trade Commission (FTC) issued a warning letter to Free Speech Systems LLC, dba Infowars.com for marketing and selling several unapproved products claiming to prevent and/or treat COVID-19. Another warning letter was issued by both agencies to Earthley Wellness dba Modern Alternative Mama LLC., for herbal tinctures and remedies marketed for prevention of COVID-19.
- Pharmacy Compounders. On April 10, FDA issued guidance for pharmacy compounders experiencing shortages of PPE. The guidance discusses temporary measures to provide some flexibility for compounders that cannot obtain sufficient supplies of PPE, provided risk mitigation strategies outlined in the guidance are adopted.
- Drug Development. As previously reported, on March 31, FDA created the Coronavirus Treatment Acceleration Program (CTAP) to expedite the development of potentially safe and effective life-saving treatments. As of April 13, FDA reports that under the program, 10 therapeutic agents are in active trials, and another 15 are in planning stages.
Ventilators, and Other Medical Products
- Ventilators. As of April 13, 24 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.
- Infusion Pump. On April 11, FDA issued an EUA for an infusion pump system for use in tracheal delivery of continuous nebulized medications into a nebulizer to treat patients suspected of having COVID-19. The EUA authorizes uses not previously cleared under the pump’s existing premarket (i.e., 510(k)) clearance.
- Blood Purification System. On April 9, FDA issued an EUA for a blood purification system to treat COVID-19 patients 18 years or older admitted to the ICU with confirmed or imminent respiratory failure. The device filters a patient’s blood to remove pro-inflammatory cytokines and other inflammatory mediators that may be elevated due to an overactive immune response. The cytokines and inflammatory mediators are associated with the “cytokine storm” that can occur in some COVID-19 patients.
- Oxygen and Nitrogen Containers. Given the demand for critical medical gases, on April 9, FDA issued guidelines to temporarily expand the availability of portable cryogenic oxygen and nitrogen containers. The FDA does not intend to take enforcement action against firms that fill and distribute oxygen and nitrogen in portable cryogenic medical gas containers that do not comply with certain regulatory requirements, provided that alternative, specific safeguards are in place to prevent gas mix-ups.
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.*