FDA Facilitates Access to Crucial Medical Products, Including PPE and Ventilators, for COVID-19
On March 20 and 22, 2020, the U.S. Food and Drug Administration took action (https://www.fda.gov/regulatory-information/search-fda-guidance-documents/enforcement-policy-ventilators-and-accessories-and-other-respiratory-devices-during-coronavirus) to increase the availability of ventilators, testing supplies, and personal protective equipment (PPE) during the COVID-19 coronavirus pandemic to support patients with respiratory failure or difficulty breathing.
Personal Protective Equipment
FDA has been working closely with PPE manufacturers to understand their supply capabilities during this pandemic. The agency is also aware of supply chain challenges presently affecting the availability of PPE products and is taking steps to mitigate shortages that healthcare facilities are already experiencing. For example, on March 2, the FDA granted an emergency use authorization (EUA (https://www.fda.gov/media/135763/download)) to allow National Institutes of Occupational Safety and Health-approved respirators typically used in industrial settings to be used in healthcare settings. The agency has also published a letter to healthcare providers (https://www.fda.gov/medical-devices/letters-health-care-providers/surgical-mask-and-gown-conservation-strategies-letter-healthcare-providers) and FAQs that provide conservation strategies for gowns and masks and continues to coordinate and communicate with interagency and state partners to help ensure that they are more readily available.
On March 20, 2020, the agency also issued a letter to healthcare providers (https://www.fda.gov/medical-devices/letters-health-care-providers/medical-glove-conservation-strategies-letter-health-care-providers) sharing conservation strategies for surgical gloves, recognizing that the need for PPE, such as medical gloves, may outpace the supply available to healthcare organizations during the COVID-19 pandemic. Proposed conservation strategies include using nonsterile disposable patient examination gloves for routine patient care or using medical gloves beyond the manufacturer-designated shelf life in settings with a lower risk of transmission.
The guidance outlined (https://www.fda.gov/regulatory-information/search-fda-guidance-documents/enforcement-policy-ventilators-and-accessories-and-other-respiratory-devices-during-coronavirus) the agency’s intention to exercise enforcement discretion for certain modifications to these FDA-cleared devices. Normally, any time a manufacturer or user makes a modification to a ventilator device (e.g., adding wireless or Bluetooth capability for remote monitoring), the modifications can often trigger an FDA premarket review, which can delay the time it takes to get the devices to the bedside. The guidance also helps manufacturers ramp up their manufacturing by adding production lines or alternative sites (e.g., using nonmedical device manufacturers such as automobile manufacturers) to start manufacturing ventilator parts. In recognition of the current pandemic situation, and to ease regulatory burden on manufacturers, FDA is being flexible in not enforcing the premarket review requirement for those modifications.
It also allows hospitals and healthcare professionals to use ventilators intended for other environments. For example, the guidance notes hospitals that could repurpose ventilators normally used for transporting patients in an ambulance into the hospital setting for long-term use. FDA also provides recommendations for other alternatives that should be considered such as devices for treating sleep apnea (continuous positive airway pressure devices).
FDA’s policy also applies to healthcare facilities that use ventilators beyond their indicated shelf life, which should increase ventilator capacity.
Finally, the agency encouraged manufacturers, whether foreign or domestic, to talk to FDA about pursuing an EUA, which would allow them to distribute their ventilators in the United States. This includes U.S.-based manufacturers that were previously engaged in making medical devices but have capabilities to increase ventilator supply.
FDA is responding to questions from diagnostic laboratories about the availability of certain testing supplies and updating in real time frequently asked questions (https://www.fda.gov/medical-devices/emergency-situations-medical-devices/faqs-diagnostic-testing-sars-cov-2) from labs and test developers, providing information on alternative sources of reagents, extraction kits, swabs, and more. Laboratories can call 888-INFO-FDA with any questions they may have about the EUA process or getting supplies.
Visit FDA’s COVID-19 page (https://www.fda.gov/emergency-preparedness-and-response/mcm-issues/coronavirus-disease-2019-covid-19) for more information about the agency’s response to the pandemic.