The Food & Drug Administration (FDA) issued two guidance documents for COVID-19 medical and testing devices after the expiration of the public health emergency declaration in May. The first guidance is for Transition Plan for Medical Devices That Fall Within Enforcement Policies Issued During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency, and the second is Transition Plan for Medical Devices Issued Emergency Use Authorizations (EUAs) Related to Coronavirus Disease 2019 (COVID-19).

Transition Plan for Enforcement Policies

The first guidance establishes a 180-day transition period. After November 7, the FDA will only allow for the distribution of medical devices used during the public health emergency if they are under FDA regulatory review or the manufacturers intend to stop distribution. The March 2023 transition plan for medical devices under the enforcement policy applies to digital pathology devices used in remote reviewing and reporting digital pathology slides. The enforcement policy entitled, Enforcement Policy for Remote Digital Pathology Devices During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency, allowed for the use of digital pathology devices such as automated digital image manual interpretation microscopes, whole slide imaging systems, digital pathology image viewing and management software, and digital pathology displays.

Therefore, clinical laboratories can continue using these devices before August 2023 if the device is (1) restored to an FDA-cleared or approved version or (2) an electronic copy of the updated labeling accurately describes the product features and regulatory status.

Transition Plan for EUAs

The FDA developed this guidance as a transition plan for emergency use authorizations issued during the emergency declaration. The guidance outlines the FDA’s transition plan for medical devices, including laboratory-developed tests (LDTs), related to coronavirus disease 2019.

Clinical laboratories can continue using the authorized devices while it is under FDA review. For LDTs, the FDA intends to exercise enforcement discretion as it does with other LDTs. Manufacturers are required to have a communications plan for clinical laboratories, but the FDA will review information available publicly. The FDA will also classify emergency use authorization devices as part of this regulatory review. For devices no longer available for distribution, the FDA will allow these clinical tests to remain on the market if the device is:

1. Restored to an FDA-cleared or approved version; or
2. An electronic copy of the updated labeling accurately describes the product features and regulatory status (eg, the product lacks FDA clearance, approval, or authorization).