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Tag: OIG

Study Prompts OIG to Call for Further Training of FDA Medical Device Reviewers

510(k), CDRH, FDA, Medical Devices, OIGFDA

On June 5, 2012, the Office of the Inspector General (“OIG”) published a report entitled, “Executive Summary: Scientific Disagreements Regarding Medical Device Regulatory Decisions.” The Summary, found here, details a study undertaken by the OIG, an office in the Department …

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