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FDA Plans to Finalize 510(k) Change Guidances Ahead of November Deadline By Michael Mezher - Published 13 September 2017

An official from the US Food and Drug Administration (FDA) says the agency is working to finalize two draft guidances detailing when a new 510(k) is required for changes to medical devices and their software before the 8 November 2017 deadline set by the 21st Century Cures Act.

Categories: News, US, FDA, Medical Devices, Submission and registration

Tags: 510(k) changes, 510(k) modification, Software