Tag: MDUFA V

What is the FDA Breakthrough Device Designation?

Medical Devices April 16, 2024

The FDA Breakthrough Device Designation was created in 2015 to expedite device access for life-threatening and debilitating diseases. What is the FDA Breakthrough Device Designation? The...

FDA Pre-Submission Format and Content Requirements

Medical Devices June 28, 2023

FDA Guidance on PMA and MDUFA V: Performance Goals

Medical Devices February 17, 2023

FDA Guidance on PMA and Review Clock: Overview and Main Actions

Medical Devices February 17, 2023

FDA on 510(k) and Review Clock: MDUFA Goals

Medical DevicesFebruary 9, 2023

The new article highlights the aspects related to the initial review of submissions, including the stages of the...

FDA Guidance on 510(k) and Review Clock: Overview

Medical DevicesFebruary 7, 2023

The article provides an overview of the regulatory requirements related to the actions to be taken by the...

FDA Guidance on Deficiencies and the Least Burdensome Approach: Deficiency Letters

Medical DevicesNovember 22, 2022

The new article describes in detail the aspects related to the content of deficiency letters, their review, as...

What is MDUFA V?

Medical DevicesOctober 10, 2022

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