FDA Warns Siemens Over Biochemical Device Design

Law360, New York (June 5, 2012, 8:21 PM EDT) -- The medical diagnostics division at Siemens AG failed to follow proper procedures related to design of a device that uses blood samples to check for serious diseases, the U.S. Food and Drug Administration said in a warning letter released Tuesday.

The letter, which threatens device seizure and fines if action isn’t taken, spotlights several issues with Siemens’ internal controls, including improper review and documentation of design changes.

In one instance, the company was required to assess whether a new premarket submission was required for a design...
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