Q: What happens to authorized devices after the public health emergency is over?Ī: The FDA may revise or revoke EUAs during a declared emergency for certain reasons, including if revising or revoking the EUA is appropriate to protect the public health or safety. Importing Medical Devices During the COVID-19 Pandemic.Registration and Listing of Medical Devices during the COVID-19 Pandemic.Please review the following for additional information: Q: If an authorized device needs to be imported, do the importers need to register and list?Ī: Importers must register and list if required by the device’s EUA letter of authorization. For products intended to address important public health issues related to COVID-19, CDRH will conduct its review as quickly as possible. CDRH will strive to meet deadlines established under the FDA’s user-fee program for products submitted under 510(k).
Q: Are 510(k) submissions for devices covered by an EUA also expedited?Ī: The FDA is committed to providing timely access to critical devices to address the COVID-19 pandemic. This page lists current EUAs issued for medical devices during the COVID-19 pandemic as well as EUAs issued during previous public health emergencies.įor all EUAs issued by the FDA, refer to Emergency Use Authorization.
Q: How do I know if the FDA has issued an EUA for a medical device?Ī: For medical device EUAs, go to Emergency Use Authorizations for Medical Devices. This page provides answers to frequently asked questions about EUAs and medical devices during the COVID-19 pandemic. This chart summarizes the process for EUA issuance.
During a public health emergency, the FDA can use its Emergency Use Authorization (EUA) authority to allow the use of unapproved medical products, or unapproved uses of approved medical products, to diagnose, treat, or prevent serious or life-threatening diseases when certain criteria are met, including that there are no adequate, approved, and available alternatives.īefore the FDA can issue an EUA, the Secretary of Health and Human Services must make a declaration of emergency or threat justifying authorization of emergency use for a product.
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