Newspaper article from our research archive:

Advanced Orthopaedics of South Florida.(BIMO/NIDPOE/ORI/OHRP)

Lake Worth, FL, May 6 (CDRH)

An FDA inspection conducted Dec. 13-21 found "serious violations" of regulations regarding IDES, protection of human subjects and other regulations, according to FDA's warning letter.

The agency cited the company for failing to ensure proper monitoring of the investigation, obtain IRB review and approval, submit an IDE application to FDA, receive FDA approval of the IDE before beginning the investigation, and control devices under investigation.

The sponsor of research is required to obtain a new IDE if a significant risk device that is approved for one indication is intended to be used in a clinical study for a new indication. Clinical ...

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