- February 22, 2022
- 1:00 PM - 2:30 PM ET
On February 22, 2022, the U.S. Food and Drug Administration (FDA) hosted a webinar for stakeholders interested in learning more about the draft guidances on 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 draft guidances on COVID-19 transition plans
In response to the COVID-19 Public Health Emergency (PHE), the device supply chain has been stressed because the demand for certain devices has exceeded available supply. The FDA recognized early in the COVID-19 PHE the importance of maintaining the availability of certain devices. During a PHE, the FDA has important authorities it can use to help address novel challenges, such as those encountered during the COVID-19 PHE.
In particular, following the declaration by the Secretary of HHS that circumstances exist to justify the emergency use of medical products, the FDA may issue an emergency use authorization (EUA) to allow unapproved medical products or unapproved uses of approved medical products to be used in an emergency to diagnose, treat or prevent serious or life-threatening diseases or conditions caused by chemical, biological, radiological and nuclear threats when there are no adequate, approved and available alternatives.
In addition to issuing EUAs for devices during the PHE, the FDA has also issued guidance documents describing enforcement policies for certain medical devices that are intended to support the emergency response to the COVID-19 PHE. These policies are helping to facilitate the availability of tests and personal protective equipment, as well as to expand the availability and remote monitoring capabilities of certain devices, including infusion pumps and non-invasive remote patient monitoring devices, to reduce the risk of exposure for patients, health care providers and other health care professionals to COVID-19.
Given the magnitude of the COVID-19 PHE, the FDA recognizes that continued flexibility, while still providing necessary oversight, will be appropriate to facilitate an orderly and transparent transition back to the eventual resumption of normal operations. Further, the FDA is taking into account that the manufacture, distribution, and use of devices in the context of the COVID-19 PHE 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 equipment that fall within enforcement policies or under an EUA.
While the current pandemic response remains the FDA's top priority, to provide clarity to all manufacturers, the FDA issued two draft guidance documents to provide recommendations to manufacturers that may or may not want to continue to distribute medical devices after the PHE ends or the relevant EUA declaration is terminated.
See the draft 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) During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency
Presentation, printable slides, and transcript are available at CDRH Learn under “Specialty Technical Topics”, sub-section “Public Health Emergencies”.