FDA To End Program That Hid Millions Of Reports On Faulty Medical Devices

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. The program, which began about 20 years ago, was so little-known that forensic medical device experts and even a recent FDA commissioner were unaware of its existence. Former FDA official Dr. S. Lori Brown said ending the program now is a “victory for patients and consumers.” “The No. 1 job of the FDA — it shouldn’t

From https://khn.org/news/fda-to-end-program-that-hid-millions-of-reports-on-faulty-medical-devices/

from
https://healthnews010.wordpress.com/2019/05/04/fda-to-end-program-that-hid-millions-of-reports-on-faulty-medical-devices/

From https://heidifrost.blogspot.com/2019/05/fda-to-end-program-that-hid-millions-of.html

from
https://heidifrost0.wordpress.com/2019/05/04/fda-to-end-program-that-hid-millions-of-reports-on-faulty-medical-devices/