"Since the start of the pandemic, the FDA has issued emergency use authorization for more than 800 devices that are essential to protecting the public health, including COVID-19 tests and PPE, and facilitated access to many more through its flexible policies. While we continue working to defeat this virus, the agency is seeking early feedback on a plan to assist stakeholders, including industry, healthcare professionals, and patients, with a smooth transition away from these temporary emergency measures to the eventual resumption of normal operations." According to Jeff Shuren, M.D., J.D., director of the FDA's Center for Devices and Radiological Health.
The draft guidances, when finalized, are intended to:
- Help prepare manufacturers and other stakeholders for the orderly and transparent transition to the eventual resumption of normal operations
- Foster compliance with applicable requirements under the Federal Food, Drug, and Cosmetic Act (FD&C Act) and implementing regulations when the relevant EUA declarations and COVID-19-related enforcement policies cease to be in effect
- Help avoid supply disruptions
- Facilitate continued patient and healthcare provider access to medical devices needed in the prevention, treatment, and diagnosis of COVID-19 as manufacturers take steps to transition their devices through traditional submission pathways
- Describe recommendations regarding submitting a marketing submission and the timeline for doing so
- Provide examples to illustrate the transition policies and exemplify the 180-day transition period timeline
Although these draft guidances are not for implementation at this time, manufacturers are encouraged to pursue any required marketing submissions through the appropriate regulatory pathway (for example, 510(k), De Novo, PMA) during the public health emergency if they plan to continue distribution after the public health emergency ends or the relevant EUA declaration is terminated.
These draft guidances will be open for public comments for 90 days at www.regulations.gov until March 23, 2022, under the docket numbers listed below.
The FDA encourages all stakeholders to comment on the specific topics listed in the notices of availability and on the draft guidance web pages:
Docket number FDA-2021-D-1118 for Transition Plan for Medical Devices That Fall Within Enforcement Policies Issued During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency; Draft Guidance