The US Food and Drug Administration (FDA) has made several changes to its guidances for transitioning medical devices and diagnostics from COVID-related authorization to traditionally marketed products – but it hasn’t budged on the 180-day transition timeline.
On 24 March, the FDA Center for Devices and Radiological Health (CDRH) published two final guidances for transitioning medical devices and diagnostics that have been temporarily allowed on the market due to the COVID-19 pandemic public health emergency (PHE). The Biden administration has said it does not plan to renew the PHE after 11 May, which means many products currently on the market will need to transition to traditional pathways.
“Given the magnitude of the response to the COVID-19 pandemic, CDRH is taking steps to assist stakeholders, including industry, health care professionals, and patients, who may need time to transition from certain temporary emergency measures,” said CDRH Director Jeff Shuren. “CDRH developed these transition guidances to help avoid disruption in device supply and facilitate compliance with applicable requirements while providing stakeholders with recommendations and an appropriate transition period to ensure an orderly and transparent transition to normal operations.”…
