New FDA Documents On Weight-Loss Devices, Software And International Harmonization As End Of Fiscal Year Nears
With the end of fiscal 2023 just over a week away, the US Food and Drug Administration has been publishing promised guidance documents, action plans and white papers. Medtech Insight’s round-up of four device-specific documents is below.
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The US FDA has finalized a guidance document on the Voluntary Improvement Program, which aims to help manufacturers continuously improve quality and compliance.
As part of its ongoing effort to modernize its the US FDA has issued three draft guidance documents it says will improve the safety of critical medical devices and strengthen the submission process.
A revised guidance for face masks and barrier face coverings changes the language of the title and text to reflect the end of the PHE.