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Warning Letters Medical Devices Healthcare

Arnall Golden Gregory LLP

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

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

Knobbe Martens

Updates in the FDA’s Regulation of Digital Health Technologies

Knobbe Martens on

The FDA issued a warning letter to Abiomed, for failing to seek approval for its Impella Connect System software before putting it on the market. The Impella Connect System software is designed to work with the company’s...more

King & Spalding

FDA Releases Warning Letters to Providers Concerning Clinical Trial Supervision

King & Spalding on

The FDA recently released three warning letters that it previously issued to two health care providers relating to prescription drug and medical device clinical trials. The letters, sent in late 2013 and early 2014, detail...more

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