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Stephanie Zeppa is a partner in the Corporate & Securities Group in the firm's San Francisco office.

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 are used for health related applications (e.g., smartwatches that connect to glucose meters).  In the healthcare space, accessories can potentially face regulation by the Food and Drug Administration (FDA) if they are intended to support, supplement, and/or augment the performance of one or more regulated parent devices, but there has been a lack of clarity from the FDA on what types of accessories will be regulated.  In January 2015, the FDA released guidance[1] to address concerns from the medical device industry and more recently the health information technology industry on the following topics.
Continue Reading Go For De Novo: FDA’s Revised Approach to Medical Device Accessories

2015 has been a busy year for the Food and Drug Administration (FDA).  In January, the FDA issued guidance documents addressing wellness applications[1] as well as accessories to medical devices and it looks like the administration is continuing the trend into February with a finalized regulatory approach to Medical Device Data Systems (MDDS)[2].  All three of these documents seemed to trace a common line of promoting health information technology (HealthIT) innovation and demonstrate the prevalence the field has had into the FDA’s thinking.  Before addressing the applicability to HealthIT, we briefly examine the impact the current guidance has on MDDS regulation.
Continue Reading Interface without Regulation – FDA Deregulates MDDS and Related Technologies

On January 20, 2015, the FDA issued draft guidelines[1] designed to give developers whose products and applications promote healthy lifestyles (so-called “general wellness products”) direction on when such products qualify as medical devices under Section 201(h) of the Food Drug & Cosmetics Act (the “Act”) and are therefore subject to the Act’s regulatory requirements for devices.
Continue Reading FDA Issues Guidance for Low-Risk General Wellness Products

On April 7, 2014, the Food and Drug Administration (FDA), in consultation with the Office of the National Coordinator for Health Information Technology (ONC) and the Federal Communications Commission (FCC) released a draft report addressing a proposed strategy and recommendations on an “appropriate, risk-based regulatory framework pertaining to health information technology.”
Continue Reading Proposed health IT strategy aims to promote innovation

Apple’s apps store lists close to a 100,000 health apps.  Together with wearable technology, direct-to-consumer testing services, and greater consumer participation in the decision to purchase health insurance, the healthcare market in the United States is undergoing a significant transformation.  Whether and how to regulate this evolving market is subject to substantial discussion and debate.
Continue Reading Mobile Medical App Regulations on the Move – Proposed Bills To Further Alter the Regulatory Landscape of 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 smartphones and other mobile devices. The final guidance reflects a tailored approach by the Agency to analyzing mobile medical apps, and represents an important step in narrowing the field of interpretation of the current laws.
Continue Reading The FDA Releases Long-Awaited Final Guidance on Mobile Medical Applications