The Food and Drug Administration responded Wednesday to a Freedom of Information Act request filed months ago, noting that the information sought by Kaiser Health News “is now posted online.” KHN had filed a series of FOIA requests, beginning in September 2018, seeking hidden reports of malfunctions or injuries tied to scores of medical devices. The FDA said fulfilling the requests would take up to 22 months and denied a KHN request for expediting the process because there was no “compelling need” to release the information. In the meantime, KHN published a series of stories that showed more than a million reports had been filed to the hidden database, bypassing the public database known as MAUDE that doctors, researchers and patients rely on to spot problems with devices.
from https://khn.org/news/fda-ends-months-long-foia-battle-over-medical-device-failures-says-putting-database-online-satisfies-khn-request/
from
https://healthnews010.tumblr.com/post/186041943703
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