FDA Finalizes Guidance on Postmarket Device Surveillance

The US Food and Drug Administration (FDA)
on Friday finalized guidance (five years after draft guidance was first released) for device manufacturers on its interpretation of the law with regard to postmarket surveillance of certain class II or class III devices.
The guidance comes as the Government Accountability Office (GAO) said last October that 90% of the postmarket surveillance studies FDA ordered over the past seven years were categorized as inactive, though some of these studies were added to other ongoing studies.
Most recently, FDA sent a warning letter to Israel-based Argo Medical Technologies after its failure to conduct such post-market surveillance studies for its device meant to help individuals with spinal cord injuries.

To read the article by Zachary Brennan