03/27/2023: Lab Update: FDA Issues Final Guidances for COVID-19 Medical Device Transition Plans

CDC's Laboratory Outreach Communication System (LOCS)

Audience: Laboratory and Testing Professionals

Level: Laboratory Update

On March 24, 2023, the U.S. Food and Drug Administration (FDA) issued final guidances for the following transition plans:

  1. Medical Devices That Fall Within Enforcement Policies Issued During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency
  2. Medical Devices Issued Emergency Use Authorizations (EUAs) Related to Coronavirus Disease 2019 (COVID-19)

The guidances outline FDA’s general recommendations to transition from certain policies adopted and operations implemented during the COVID-19 pandemic to normal operations. The recommendations include information for devices that fall within certain enforcement policies issued during the COVID-19 public health emergency (PHE) under section 319 of the Public Health Service Act and devices issued EUAs related to COVID-19 under section 564 of the Federal Food, Drug, and Cosmetic Act.

There will be a 180-day transition period for impacted devices. Manufacturers who plan to continue distributing their devices after either the end of the transition period following the expiration of the COVID-19 PHE or termination of the relevant device EUA declaration related to COVID-19 should refer to information on the scope and timeline for the transition period found in each guidance link above.

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Laboratory Outreach Communication System | Division of Laboratory Systems (DLS)

Office of Laboratory Science and Safety (OLSS)

Centers for Disease Control and Prevention (CDC)