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Fraud-on-the-FDA As A Basis for A False Claims Act Lawsuit: Is It Dead Or Just Resting?

FDA Law Blog

JUNE 12, 2022

established by statute and case law. The DOJ notes that “device manufacturers are required to investigate adverse events and report information to the FDA within 30 days of becoming aware of information that the marketed device “[h]as malfunctioned. . . This fraudulent inducement theory is well?established

Manufacturing

Manufacturing Contract Data Management Statute

The Incredible Shrinking Exemption: FDA Final CDS Guidance Would Significantly Narrow the Scope of Exempt Clinical Decision Support Software Under the Cures Act

FDA Law Blog

OCTOBER 10, 2022

Consistent with the 2019 draft guidance, the final guidance also includes textbooks, approved drug or medical device labeling, and government agency recommendations as other permissible types of medical information. Criterion 4: The fourth criterion seeks to ensure that Non-Device CDS does not supplant an HCP’s independent clinical judgment.

Drafting

Drafting Statute Data Management Manufacturing

Paralegal Brief

Fraud-on-the-FDA As A Basis for A False Claims Act Lawsuit: Is It Dead Or Just Resting?

The Incredible Shrinking Exemption: FDA Final CDS Guidance Would Significantly Narrow the Scope of Exempt Clinical Decision Support Software Under the Cures Act

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