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ANSI Medical Devices

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

MoFo Life Sciences

CTA Publishes New Standard For Healthcare AI

MoFo Life Sciences on

In February, the Consumer Technology Association (CTA) announced a voluntary standard for healthcare products that use Artificial Intelligence (AI). This standard follows the Food and Drug Administration’s (FDA) recently...more

Akin Gump Strauss Hauer & Feld LLP

Under What Circumstances Can a Private Qui Tam Plaintiff Overrule Government Agency Experts' Use of Administrative Discretion to...

• How have appellate courts applied the Supreme Court’s ruling in Escobar? • If the government is aware of the relator’s allegation, but does not undertake any administrative action to address the defendant’s alleged...more

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