During the COVID-19 pandemic, the US Food and Drug Administration (FDA) allowed more than 4,000 medical devices and diagnostics on the market under emergency use authorization (EUA) or enforcement discretion. Those products can’t stay on the market indefinitely – and a top agency official has some tips on how to transition such products to traditional marketing pathways.
Focus recently spoke with William Maisel, chief medical officer and director of the Office of Product Evaluation and Quality at the Center for Devices and Radiological Health (CDRH). Here are his top 10 tips on transitioning products.
1. Understand the transition plan
In December 2021, FDA published two draft guidances outlining a risk-based transition plan that would give manufacturers with EUAs and those with products under agency enforcement discretion 180 days’ notice to either stop marketing their products or seek permanent marketing authorization. (RELATED: FDA proposes 180-day transition before terminating COVID-19 EUAs, enforcement policies, Regulatory Focus 4 January 2022)
“The plan that we proposed is intended to facilitate continued patient, consumer and healthcare provider access to COVID-related devices,” said Maisel. “Our goal is an orderly and transparent transition consistent with the agency’s mission.”
“Having a common understanding of the purpose, intent and approach of the transition planning will really help sponsors understand the purpose of many of the recommendations in the guidance documents,” he added…
