News & Analysis as of

Federal Food Drug and Cosmetic Act (FFDCA) Wearable Technology

Gardner Law

Whoop vs. FDA

Gardner Law on

In FDA regulatory matters, companies must carefully choose when to challenge the government, and when to comply. In a recent case, Whoop, the Boston-based wearable maker, has chosen to openly challenge the U.S. Food and Drug...more

Proskauer on Privacy

Regulators Offer Guidance on Privacy and Security for Health App Developers

Proskauer on Privacy on

This month, the Federal Trade Commission (FTC) issued guidance on privacy and security best practices for health-related mobile apps, such as fitness apps connected with wearables, diet and weight loss apps, and health...more

Sheppard Mullin Richter & Hampton LLP

FDA Issues Guidance for Low-Risk General Wellness Products

On January 20, 2015, the FDA issued draft guidelines designed to give developers whose products and applications promote healthy lifestyles (so-called “general wellness products”) direction on when such products qualify as...more

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