The US FDA is planning to issue transition plans for medical devices with Emergency Use Authorizations (EUAs). The EUA measure had previously been implemented in order to promote and ensure the necessary medical product supply, especially Personal Protective Equipment (PPE) products, are being met. In this respect, FDA provided guidance and templates for manufacturers, which allowed them to quickly enter the US market via the EUA process.
However, as the Coronavirus Disease 2019 (COVID-19) pandemic gradually slows down, the FDA draft guidance on transition plans for EUA devices distinctly indicates that once the public health emergency abates, how manufacturers should proceed, so to remain on the US market after their EUA designations have expired. At this moment and until March 23rd 2022, FDA yet still accepts comments regarding this draft guidance from Industry and other stakeholders.
Currently Marketed EUA Medical Devices:
FDA will require the medical device to get 510(k) clearance after its EUA designation expires. If the EUA device cannot obtain 510(k) clearance, the device will no longer be allowed to be kept on the US market. Furthermore, FDA will provide an EUA termination notice to the manufacturers 180 days before EUA designation expires (in the US Federal Register).
For EUA Devices Planning FDA Registration:
FDA will allow the device to be marketed continuously, in case the product has completed the full US market access process.
For EUA Devices Not Planning FDA Registration:
When a manufacturer does not intend to continue to distribute its device on the US market beyond the EUA termination date, FDA does not intend to object to the disposition (market removal) of already distributed devices as follows:
1. Single-use, non-life-supporting/non-life-sustaining devices, such as face masks, which were distributed before the EUA termination date can remain distributed and are consumed by the end-user.
2. Reusable, non-life-supporting/non-life-sustaining devices such as remote patient monitoring devices that were distributed before their EUA termination date can also remain distributed and are used by their end-user. Such devices should either:
- 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 (i.e., that the product lacks FDA clearance or approval).
3. Reusable life-supporting/life-sustaining devices like ventilators or oxygenation systems, that were distributed before the EUA termination date can remain distributed. Such devices should either:
- a. Be restored by the manufacturer to the previously FDA-cleared or approved version of the device, or - b. Have both publicly available and a physical copy of labeling that accurately describes the product features and regulatory status (i.e., that the product lacks FDA clearance or approval).
4. In vitro diagnostic (IVD) devices that were distributed before the EUA termination date can remain distributed and are used for no more than 2 years after the EUA termination date or until the expiration date, whichever is less.
- Transition Plan for Medical Devices Issued Emergency Use Authorizations (EUAs) During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency