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Medical Devices › Corrective Actions

King & Spalding

FDA Finalizes Its Premarket Submissions Guidance for Medical Device Software Functions

King & Spalding on

On June 14, 2023, FDA finalized its “Content of Premarket Submissions for Device Software Functions: Guidance for Industry and Food and Drug Administration Staff” (the “2023 Final Guidance”). The Final Guidance replaces the...more

The Volkov Law Group

Alere Agrees to Pay $38.75 Million to Settle False Claims Act Violations (Part II of V)

The Volkov Law Group on

Alere, Inc. and its San Diego subsidiary, agreed to pay $38.75 million to resolve False Claims Act charges for billing the Medicare program for defective rapid point-of-care testing devices. ...more

King & Spalding

Federal Government Takes Steps Toward Enforcement of ClinicalTrials.gov Requirements

King & Spalding on

Time Is Ripe To Update SOPs And To Ensure Compliance with Results Submission Requirements - In recent days, the federal Department of Health and Human Services (“HHS”) clarified the requirements for submission of certain...more

Searcy Denney Scarola Barnhart & Shipley

FDA Takes Strong Action to Protect Patients — Breast Institute at JFK Medical Center

Searcy Denney Scarola Barnhart & Shipley on

West Palm Beach, Florida - The US Food and Drug Administration (FDA), has recently taken the extraordinary step of requiring The Breast Institute at the JFK Medical Center North, located at 2201 45th Street in West Palm...more

Bricker Graydon LLP

New cybersecurity threats with potential to impact health care industry identified

Bricker Graydon LLP on

On January 4, 2018, the National Health Information Sharing and Analysis Center (NH-ISAC) posted an announcement regarding the cybersecurity threats Meltdown and Spectre that were recently identified....more

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