Stephanie Zeppa

Sheppard Mullin Richter & Hampton LLP

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Latest Posts › Medical Devices

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Go For De Novo: FDA’s Revised Approach to Medical Device Accessories

Accessories are an everyday reality for almost all users of technology products today. They can help improve efficacy, increase usability and make many other improvements to the technology we use. Increasingly, accessories...more

2/20/2015 / Food and Drug Administration (FDA) , Healthcare , Medical Device Accessories , Medical Devices , New Guidance

Interface without Regulation – FDA Deregulates MDDS and Related Technologies

2015 has been a busy year for the Food and Drug Administration (FDA). In January, the FDA issued guidance documents addressing wellness applications as well as accessories to medical devices and it looks like the...more

2/13/2015 / Food and Drug Administration (FDA) , Medical Device Accessories , Medical Devices , New Guidance

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

1/26/2015 / Draft Guidance , Federal Food Drug and Cosmetic Act (FFDCA) , Food and Drug Administration (FDA) , Medical Devices , Mobile Apps , Wearable Technology , Wellness Programs

The FDA Releases Long-Awaited Final Guidance on Mobile Medical Applications

On September 23, 2013, the U.S. Food and Drug Administration (the “FDA” or the “Agency”) issued long-awaited final guidance for developers of mobile medical or health applications (or “mobile medical apps”) used on...more

9/25/2013 / Food and Drug Administration (FDA) , Healthcare , Medical Devices , Mobile Apps , Mobile Devices , Telemedicine

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