- April 18, 2023
- 1:00 PM - 2:30 PM ET
On April 18, 2023, the U.S. Food and Drug Administration (FDA) hosted a webinar for stakeholders interested in learning more about the two final guidances on the Coronavirus Disease 2019 (COVID-19) transition plans for medical devices.
During this webinar, the FDA:
- Helped prepare manufacturers and other stakeholders for the orderly and transparent transition to normal operations.
- Described recommendations regarding submitting a marketing submission and the timeline for doing so.
- Provided examples to illustrate the transition policies and exemplify the 180-day transition period timeline.
- Answered your questions about the guidances on the COVID-19 transition plans.
In response to the COVID-19 pandemic, the device supply chain has been stressed because the demand for certain devices has exceeded available supply. As such, since the beginning of the COVID-19 pandemic, FDA took a number of proactive steps to help facilitate the availability of critical medical devices, including issuing emergency use authorizations (EUAs), which has enabled access to medical devices to help diagnose, treat, or prevent COVID-19. In addition, FDA issued guidances to help expand the availability of certain devices to help patients, health care providers, and other health care professionals access devices for COVID-19-related uses.
Given the magnitude of the COVID-19 pandemic, the FDA recognizes that stakeholders may need time to adjust to help ensure an orderly and transparent transition to normal operations. Further, the FDA is taking into account that the manufacture, distribution, and use of devices in the context of the COVID-19 pandemic raises unique considerations. These considerations include, for example, the manufacturing of devices by non-traditional manufacturers to address supply issues and the distribution and use of capital or reusable equipment that fall within enforcement policies issued during the COVID-19 public health emergency (PHE) declared under section 319 of the Public Health Service Act or under relevant device EUA declarations related to COVID-19 issued under section 564 of the Federal Food, Drug, and Cosmetic Act.
To provide clarity to manufacturers, the FDA issued two guidance documents to provide recommendations to manufacturers that may or may not want to continue to distribute certain medical devices after the PHE declaration expires and certain enforcement policies issued during the COVID-19 PHE are no longer in effect, or the relevant EUA declaration related to COVID-19 terminates.
See the guidances for more information:
- Transition Plan for Medical Devices That Fall Within Enforcement Policies Issued During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency
- Transition Plan for Medical Devices Issued Emergency Use Authorizations (EUAs) Related to Coronavirus Disease 2019 (COVID-19)
The presentation, printable slides, and transcript are available at CDRH Learn under “Specialty Technical Topics”, sub-section “ COVID-19 Transition Policy”.