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Regulatory Requirements › Medical Devices › FDA Warning Letters

Holland & Knight LLP

FDA Enforcement Against Dental Lab Could Have Broader Implications

Holland & Knight LLP on

The U.S. Food and Drug Administration (FDA) recently published a warning letter (Warning Letter) targeting a dental laboratory after a lengthy inspection found that the dental laboratory's operations, which offer...more

Wilson Sonsini Goodrich & Rosati

The FDA and WHOOP Debate Challenges the Line Between Wellness Products and Medical Devices

Wilson Sonsini Goodrich & Rosati on

In July 2025, the U.S. Food and Drug Administration (FDA) issued a warning letter to WHOOP, Inc. (WHOOP), asserting that the company is marketing its wearable blood pressure product, or Blood Pressure Insights (BPI), in the...more

Orrick, Herrington & Sutcliffe LLP

Will FDA’s Warning Letter to WHOOP Put a Chill on Wearables?

Orrick, Herrington & Sutcliffe LLP on

FDA’s Warning Letter to WHOOP, a manufacturer of cutting-edge, wellness wearable tech, has sent shivers through an industry enjoying exponential growth in the health and wellness space. “Wellness technology”, a result of the...more

Arnall Golden Gregory LLP

Step by Step: FDA Cracks Down on Unauthorized Medical Device Modifications

Arnall Golden Gregory LLP on

The Food and Drug Administration recently issued a Warning Letter concerning unauthorized modifications made to a previously cleared medical device (i.e., 510(k)). ...more

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