With the official end of the COVID-19 public health emergency in the US just a few short weeks away, device manufacturers are gearing up for the next step: Transitioning devices that reached market under emergency use authorizations (EUAs) or other forms of enforcement discretion to a conventional US Food and Drug Administration regulatory pathway. Medtech Insight interviewed two veteran attorneys about what steps manufacturers should prioritize.
‘Get Ahead Of The Curve’ By Preparing for EUA End, Attorneys Say
Two regulatory attorneys spoke to Medtech Insight about the most important steps to take before the public health emergency ends, as well as what enforcement tactics they expect to see from the FDA.

More from Regulation
The US FDA has published its final document to guide sponsors on using sex-specific data in designing clinical trials of medical devices. However, the guidance removes all references to gender that appeared in January’s draft guidance, released before the Trump administration took office.
Calley Means defended reductions in force at the Health and Human Services Department that shocked and outraged federal workers and stakeholders.
A seemingly humorous social media post on April Fool’s Day struck a nerve with regulatory experts, reflecting real concerns about recent actions by the US Food and Drug Administration.
Mass FDA layoffs on 1 April were designed to spare product reviewers, but still touched many who are critical to the application review process or drug development, which could mean fewer treatments are brought to the US market first.
More from Policy & Regulation
Some employees were not impressed with FDA Commissioner Martin Makary's first speech to the agency staff, saying he did not seem to understand the agency's mission.
Swiss medtech exporters seek urgent diplomatic action from the Swiss Federal Council in a bid to overturn the 2 April US decision to put tariffs on goods imports.
Energy and Commerce Health Subcommittee Democrats focus on criticizing HHS Secretary Kennedy’s RIF announcement, including 3,500 FDA jobs among cuts across HHS agencies. Representatives were left wondering if user fee programs would continue, even if reauthorized.