US FDA Emergency Use Pathways for Medical Devices and IVDs

The US FDA has declared the COVID-19 outbreak to be a public health emergency and invoked their authorities for Emergency Use Authorization (EUA), through which the FDA Commissioner may allow unapproved medical devices to be used for emergency applications.

The FDA has designated several categories of devices under this authority, and has so far made regular updates.

Regulations, guidance, and resources

The following are a list of the major FDA documents and publications related to EUAs for COVID-19:

Device types and eligibility criteria

As of the date of publishing, the FDA has included the following device types under EUA:

  • Ventilators (and ventilator tubing connectors, and ventilator accessories)
  • Personal Protective Equipment (personal respiratory protective devices)
  • In Vitro Diagnostics (COVID-19 diagnostic device)

As updates may be made, please check the FDA website for the latest.

 

Learn how regulators are responding to COVID-19.

 

Pathway overview

While the exact requirements, pathway, and limitations differ slightly between product types, the following provides a general overview of the process for approval via the EUA route:

  • Submit request to FDA via email with product information
  • FDA reviews request
  • if acceptable, FDA issues approval letter
  • manufacturer complies with conditions of approval (e.g., labeling as unapproved)

For EUA devices, Quality System requirements and device listing are waived. Certain conditions of approval must be followed, such as having processes in place for reporting adverse events, recording keeping, etc.

The EUA approval is revoked when the FDA determines the emergency need is no longer needed and issues a declaration terminating all EUAs.

Additional information on pathways for specific product types can be found in the following resources:

Ventilators

  • Enforcement Policy for Ventilators and Accessories and Other Respiratory Devices During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency
  • Ventilators, anesthesia gas machines modified for use as ventilators, and positive pressure breathing devices modified for use as ventilators (collectively referred to as "ventilators"), ventilator tubing connectors, and ventilator accessories
  • Appendix A, Criteria for Safety, Performance and Labeling

Respirators

  • Imported, Non-NIOSH-Approved Disposable Filtering Facepiece Respirators
  • NIOSH-Approved Disposable Filtering Facepiece Respirators for Use in Health Care Settings During Response to the COVID-19 Public Health Emergency
  • Non-NIOSH Approved Respirator EUA FAQ
  • EUA Clarification Letter on Respirators

In Vitro Diagnostics

Immediately in Effect Guidance for Clinical Laboratories, Commercial Manufacturers, and Food and Drug Administration Staff: Policy for Diagnostic Tests for Coronavirus Disease-2019 during the Public Health Emergency
FAQs on Diagnostic Testing for SARS-CoV-2
"Accelerated" Template for Laboratories Certified to Perform High-Complexity Testing Under CLIA: EUA Template 
Test Kit Manufacturer: EUA Template

Navigating special access routes in response to COVID-19

Emergo by UL consultants are monitoring the development of expedited regulatory routes in medical device markets worldwide. If your device or IVD is critical to the COVID-19 response, special access or emergency use routes may be available. Contact us if you have questions about your product's eligibility or expedited regulatory pathways in countries affected by COVID-19. 

Published on 26 March 2020.

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