Device Corrections And Removals Guidance Undertaken By Industry, FDA
This article was originally published in The Gray Sheet
Executive SummaryThe National Electrical Manufacturers Association is developing guidance to help clarify reporting of corrections and removals of medical devices
You may also be interested in...
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker.
US FDA’s latest effort to provide guidance for consumers on pharmacogenomics tests underscores the challenges the agency faces in the absence of a clear regulatory framework for lab-developed tests – and with no easy mechanism to update labels for off-patent drugs.