FDA Publishes Draft Guidances Describing General Wellness Claims and Risk-Based Classification of Accessories


FDA published two much anticipated draft guidances on January 16, 2015, which outline the Center for Devices and Radiological Health’s (CDRH) policy regarding low risk general wellness products and regulation of medical device accessories.  Although not solely focused on software, these guidances provide further clarification to the rapidly developing and expanding mobile app and software industry. 

FDA states in the draft guidance General Wellness: Policy for Low Risk Devices,” that it will not regulate low risk products in one of two categories:

FDA provides two subcategories of claims under Category 2: (1) “may help to reduce the risk of” and (2) “may help living well with.”  Thus, for example, a product that promotes physical activity as part of a healthy lifestyle “may help reduce the risk of” high blood pressure.  A software product that tracks caloric intake can help to maintain a healthy weight and balanced diet, which “may help living well” with high blood pressure and type 2 diabetes. 

In the Accessories draft guidance “Medical Device Accessories: Defining Accessories and Classification Pathway for New Accessory Types,” FDA seeks to clarify and modify its policy concerning the classification of accessories.  FDA defines an accessory as a “device that is intended to support, supplement, and/or augment the performance of one or more parent devices.”  FDA clarifies that medical device accessories will not automatically take on the classification of the parent device.  FDA intends to regulate accessories according to their individual risk in the same way FDA regulates all medical devices, and thus, accessories may be classified differently than the parent device.  For example, if the parent device is regulated as a Class III device but the accessory is low risk, the accessory could be regulated as Class I. 

Further analysis of the General Wellness and Accessories Guidances will follow in a subsequent client alert.  There is a 90 day public comment period for these guidances. 


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National Law Review, Volume V, Number 16