FDA Emphasizes Use of Real-World Evidence for Medical Device Makers
The U.S. Food and Drug Administration (FDA) has increasingly emphasized the use of real-world evidence (RWE) to support regulatory decision-making for medical devices. As medical technologies evolve and data sources...
FDA to Drop 510(k) Requirements for Certain Low-Risk Devices, Lowering Barriers to Entry
On June 5, 2026, the U.S. Food and Drug Administration (FDA) issued updated guidance stating its intent to exempt certain unclassified medical devices from premarket 510(k) requirements, and that the FDA believes the identified device...
Sheila Swaroop Quoted in MLex on Sedona Conference Model Jury Instructions for DTSA Federal Trade Secret Litigation
In a recent MLex article on The Sedona Conference’s model jury instructions for federal litigation under the Defend Trade Secrets Act (DTSA), Knobbe Martens partner Sheila Swaroop shared insights on...
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