FDA Plans Transition for Medical Devices with Emergency Use Authorizations

FDA Transition Plans for Medical Devices with EUAs

The US FDA is preparing to issue transition plans for medical devices that hold Emergency Use Authorizations (EUAs). This initiative aims to ensure the steady supply of medical products, particularly Personal Protective Equipment (PPE). Previously, the FDA provided guidance and templates to manufacturers, streamlining their entry into the US market.

Draft Guidance

The FDA has initiated draft guidance regarding these transition plans. Feedback from the Industry and Stakeholders is welcomed until March 23, 2022.

As the COVID-19 pandemic diminishes, the FDA’s draft guidance will outline the steps manufacturers should take to continue their presence in the US market after their US designations expire.

Current Rules for Medical Devices in the US

The existing rules for medical devices marketed in the US include the following provisions:

• For devices planning FDA Registration: The FDA permits continuous marketing if the product has achieved full US market access.

• For devices not planning FDA Registration: If a manufacturer does not wish to continue distributing its device in the US beyond the termination date, the FDA will not object to the market removal of already distributed devices as:

  1. Single-use, non-life-supporting/non-life-sustaining devices, such as face masks, which were distributed before the US termination date, can remain distributed and consumed by the end-user.
  2. Reusable, non-life-supporting/non-life-sustaining devices, like remote patient monitoring devices, distributed prior to their US termination date can stay distributed for end-user use. These devices should:
     • A. Be restored by the manufacturer to the previously FDA-cleared or approved version (e.g., earlier software version, component replacement), or
     • B. Have publicly available labeling that accurately describes the product features and regulatory status (indicating if the product lacks FDA clearance or approval).
  3. Reusable life-supporting/life-sustaining devices, such as ventilators or oxygenation systems, distributed before the US termination date can remain distributed. These devices should:
     • A. Be restored by the manufacturer to the previously FDA-cleared or approved version, or
     • B. Have both publicly available and physical copies of labeling that accurately describes the product features and regulatory status (indicating if the product lacks FDA clearance or approval).
  4. In vitro diagnostic (IVD) devices distributed before the US termination date may remain distributed for no more than 2 years following the US termination date or until the expiration date, whichever is sooner.