FDA Guidance On Transitioning COVID-19 EUA Products Has US Firms Watching The Clock
Stakeholders across medtech industry submit comments on FDA's itsplans to help companies looking to keep their EUA products on the market post-pandemic.
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The US FDA says in a new draft guidance document that makers of a variety of devices and diagnostics that were given wide enforcement berth by the agency to use their products to respond to COVID-19 must eventually transition back to full regulatory compliance under a proposed three-phase plan.
While the latest missions from NASA may seem like the stuff of science fiction, discoveries from outer space are not only unlocking the mysteries of the cosmos, but improving technologies used every day on Earth, including those in the medtech industry.
News We’re Watching: CDRH’s Maisel Announces Retirement, Fresenius Clearance, Philips and Smiths Recalls
This week, a device center stalwart prepared to say goodbye; the FDA cleared Fresenius's 5008X Hemodialysis System; and class I recalls for Smiths Medical and Philips Imaging were announced.