FDA to End Program That Hid Millions of Reports on Faulty Medical Devices
May 7, 2019
(Kaiser Health News) – The Food and Drug Administration announced it is shutting down its controversial “alternative summary reporting” program and ending its decades-long practice of allowing medical device makers to conceal millions of reports of harm and malfunctions from the general public. The agency said it will open past records to the public within weeks.
A Kaiser Health News investigation in March revealed that the obscure program was vast, collecting 1.1 million reports since 2016.