FDA Unveils 3-Phase Approach For Bringing Products Back Under Compliance After Pandemic Enforcement Leeway
The US FDA says in a new draft guidance document that makers of a variety of devices and diagnostics that were given wide enforcement berth by the agency to use their products to respond to COVID-19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.
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The US agency will discuss and answer stakeholder questions about two draft guidance documents it released this week related to the COVID-19 pandemic.
In a long-awaited draft guidance document, the US agency lays bare its thinking on how companies can best ensure that their products granted emergency use authorization status can still be sold post-pandemic (or not).
On this week’s podcast: From Hawaii to Missouri to Florida, the medtech industry and third-party servicers are duking it out in state legislatures over who has the right to repair and service medical devices.