News & Analysis as of

Software › Warning Letters

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

Sheppard Mullin Richter & Hampton LLP

FDA Maintains Focus on “Intended Use” for Software-Enabled Medical Devices

Sheppard Mullin Richter & Hampton LLP on

On June 21, 2023, the U.S. Food and Drug Administration (“FDA”) issued a warning letter to Zyto Technologies, Inc. (“Zyto”), citing Zyto’s promotion of its Hand Cradle Galvanic Skin Response (“GSR”) device and associated...more

King & Spalding

The Federal Trade Commission Issues Warning Letters To App Developers

King & Spalding on

On March 17, 2016, the Federal Trade Commission (“FTC”) announced it had issued warning letters to twelve application (“app”) developers who installed in their apps software created by the company SilverPush that is capable...more

3 Results
 / 
View per page
Page: of 1

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:
Sign up Log in
*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
- hide
- hide