Tag Archive | "FDA regulations"

FDA To Require Electronic Reporting of Medical Device Errors


FDA To Require Electronic Reporting of Medical Device ErrorsLast week, The U.S. Food and Drug Administration published a final rule in the Federal Register which requires that both device makers and importers document negative event reports for medical devices electronically.

“Upon the effective date of this final rule, manufacturers and importers are required to submit MDRs to the Agency in an electronic format that FDA can process, review, and archive,” the FDA announced.

The new rule formally takes effect August 14th, 2015.
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