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Orthopaedic Alerts - Implant Recall

Details
By Michelle Llamas
Michelle Llamas
Alerts
20 October 2016

Report: FDA Rules Allow Device Makers to Hide Adverse Events

fda rules allow device makers to hid adverse events

The U.S. Food and Drug Administration created a program that allows medical device makers to hide adverse events and report them years later, the Star Tribune reported.

Doctors and patients should be able to use this data to make informed decisions about treatment options, but companies like Johnson & Johnson, Stryker and Zimmer routinely reported adverse events late, summarized findings or hid them from the public. The Star Tribune’s report uncovered hundreds of thousands of such incidents.

Visit Original Source

Last Updated: 20 October 2016
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