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Medical Devices Civil Monetary Penalty Penalties

Venable LLP

OIG Reminds Us that Flat Fee Business Arrangements Aren’t Immune from AKS Scrutiny

Venable LLP on

On July 1, 2025, the Office of Inspector General (OIG) of the U.S. Department of Health and Human Services issued Advisory Opinion No. 25-08, concluding that a medical device manufacturer’s proposed payment to access a...more

Mitchell, Williams, Selig, Gates & Woodyard,...

Release Reporting/CERCLA Enforcement: U.S. Environmental Protection Agency and Morganfield, Kentucky Medical Device Design...

The United States Environmental Protection Agency (“EPA”) and Vibracoustic USA, Inc. (“VUI”) entered into an April 21st Consent Agreement (“CA”) addressing alleged violations of the Comprehensive Environmental Response,...more

King & Spalding

HHS Issues Final Rule that Expands the Requirements for Disclosure of Clinical Trial Data to ClinicalTrials.gov

King & Spalding on

On September 21, 2016, the Department of Health and Human Services (HHS) published a final rule that greatly expands the information that sponsors of “applicable drug clinical trials” and “applicable device clinical trials”...more

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