The US FDA says in a new draft guidance document that makers of a variety of devices and diagnostics that were given wide enforcement berth by the agency to use their products to respond to COVID-19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.
Makers of a variety of devices and diagnostics that were given enforcement leeway by the US Food and Drug Administration to use their products to respond to COVID-19 must eventually transition back to full regulatory compliance under a three-phase transition plan recommended by the agency in a new draft guidance document.
Published in the Federal Register on 23 December, the 24-page “Transition Plan for Medical Devices That Fall Within Enforcement Policies...
Now that the US FDA has chosen not to appeal a March ruling effectively killing the agency’s efforts to regulate lab-developed tests as medical devices, will the agency adopt a different strategy to flex its regulatory muscle?
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