Device Under Section News Today

Select updates for the 506J Guidance: proposed list of devices requiring 506J notification and clarification as to the submission of voluntary notifications

In the wake of the Department of Health and Human Services' (HHS) February announcement that they will be discontinuing the COVID-19 public health emergency (PHE) declaration on May 11, 2023...

Since the beginning of the COVID-19 pandemic, the US Food and Drug Administration (FDA or the Agency) has issued more than 80 guidance documents describing flexibilities that would be available...

Since the beginning of the COVID-19 pandemic, the US Food and Drug Administration (FDA or the Agency) has issued more than 80 guidance documents describing flexibilities that would be...

The FDA's draft guidance, Notifying FDA of a Permanent Discontinuance or Interruption in Manufacturing of a Device Under Section 506J of the...

On January 10, 2022, the US Food and Drug Administration (FDA or Agency) published a new draft guidance (Draft Guidance) on manufacturer's requirements to report certain medical device shortages.