Emergency Use Authorizations when the Emergency is Over: What Next?

Companies submitting products under the FDA Emergency Use Authorization (EUA) Guidance should keep in mind a very important submission qualification: new products or cleared products with new indications of use authorized under the EUA can no longer be used when the emergency is over unless Cleared or Approved through normal regulatory pathways. The way the EUA Guidance tells it:

Upon revocation of an EUA or its termination as a result of the termination of the HHS EUA declaration supporting it, an unapproved product or its labeling, and product information for an unapproved use of an approved product, must be disposed of pursuant to section 564(b)(2)(B) and (b)(3). (Section G. 2. Product Disposition and Continued Use)

Companies trying to meet the demands of an EUA submission, even when the demands are lower under the EUA than for a traditional FDA submission, are racing and pivoting with all hands on deck to help meet the needs of our crisis. Believing that your extraordinary efforts will not have lasting value, even in the face of doing good works, can be hard to accept.

But this need not be the case. You can use the time under EUA Authorization to:

  • Mature your quality system to fully meet FDA Quality System Regulation requirements and auditability expectations in anticipation of a future FDA inspection
  • Perform a Regulatory Roadmap or Assessment to correctly identify your product’s regulatory pathway and the correct FDA submission for your product outside of the EUA
  • Perform a Gap Assessment between your current product documentation as Authorized under the EUA and FDA expectations for a 510(k), de novo or PMA and then develop and execute a plan for filling those gaps
  • Monitor the performance of your device in the field, if possible, to collect safety and efficacy data that you can use as part of your future submission
  • In the case of regulatory uncertainties around a traditional FDA submission, you can begin developing documentation and questions for a FDA pre-submission meeting

We do not know how long the EUA will last. When it does end, we should expect the FDA to transition their efforts back to enforcing established regulations. If you have any questions or need help with an EUA submission or the transition to a submission while your product is part of an EUA, contact us. We have extensive experience and we can help expedite your efforts.

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