Content By Stephanie McArdle

Stephanie McArdle’s default image

By: Stephanie McArdle

The FDA has announced an end to the alternative summary reporting (ASR) program for medical device manufacturers and will make the data publicly accessible.

The ASR program originally launched in 2000 when device manufacturers sought an “alternative summary” reporting exemption. ASR permitted medical device manufacturers to send the FDA an accounting of device injuries and malfunctions on a periodic basis (e.g., quarterly or annually) in lieu of fulfilling their standard public reporting obligations. The ASR program actually ended in 2017, but evidence shows that device exemptions were still accepted by the FDA.