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Medical Devices › Regulatory Requirements › Warning Letters

Sheppard Mullin Richter & Hampton LLP

What to Watch: WHOOP Warning Letter

Sheppard Mullin Richter & Hampton LLP on

On July 14, the U.S. Food and Drug Administration (“FDA” or the “Agency”) issued a warning letter (the “Warning Letter”) to WHOOP, Inc. (“WHOOP”), rejecting WHOOP’s claim that its wearable “Blood Pressure Insights” product...more

Hogan Lovells

AI Health Law & Policy: Complying with FDA GMP rules for AI-enabled diagnostic devices

Hogan Lovells on

The U.S. Food and Drug Administration (FDA) recently issued a Warning Letter citing a failure to obtain marketing authorization via a premarket approval (PMA) or 510(k) clearance as well as Good Manufacturing Practice (GMP)...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

Arnall Golden Gregory LLP

There Must Be Some Misunderstanding: FDA Issues a Warning Letter to a Medical Device Company That Made the Wrong Decision on...

Arnall Golden Gregory LLP on

In 1980, the British rock band, Genesis, released “Misunderstanding.” Forty-three years later, the Food and Drug Administration and a medical device company fell into a misunderstanding about a product’s regulatory...more

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