FDA Berates Sironis for Running Unapproved Trial
The FDA slammed Sironis for running an unapproved clinical trial of its LIR closed-loop fluid administration system, saying the Newport Beach, Calif.-based company never sought the proper approvals from the federal safety bureau.
In a warning letter dated March 15 and released by the FDA this week, the agency flagged Sironis for serious violations of clinical trial regulations, saying the company failed to ask for or won an investigational device exemption for the trial.
“Your firm began an investigation of a significant risk device on November 15, 2012, and failed to submit an IDE application to FDA.
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In a warning letter dated March 15 and released by the FDA this week, the agency flagged Sironis for serious violations of clinical trial regulations, saying the company failed to ask for or won an investigational device exemption for the trial.
“Your firm began an investigation of a significant risk device on November 15, 2012, and failed to submit an IDE application to FDA.
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