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Jones Day

HHS-OIG Issues Long-Anticipated General Compliance Program Guidance for All Health Care Stakeholders

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In Short - The Situation: On November 6, 2023, the Office of Inspector General ("OIG") of the U.S. Department of Health and Human Services ("HHS") released its "General Compliance Program Guidance" ("GCPG"). The GCPG...more

MoFo Life Sciences

FDA Will Once Again Accept Pre-Submissions For All In Vitro Diagnostic Tests

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The U.S. Food and Drug Administration (FDA) released a statement on May 31, 2022, that its Center for Devices and Radiological Health (CDRH) will once again be accepting all pre-submissions for all in vitro diagnostic (IVD)...more

MoFo Life Sciences

QMSR: Welcomed By The Industry, But Lacking In Practicality

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On March 2, 2022, FDA hosted a public Device Good Manufacturing Practice Advisory Committee meeting, where the Committee discussed the proposed rule titled "Medical Devices: Quality System Regulation Amendments."...more

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