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FDA states in the draft guidance “General Wellness: Policy for Low Risk Devices,” that it will not regulate low risk products in one of two categories:

  • Category 1:  Products intended to maintain or encourage a general state of health or a healthy activity.  These products do not make any reference to diseases or medical conditions in the claim.  This category of general wellness products relate to weight management, physical fitness, relaxation or stress management, mental acuity, self-esteem, sleep management, or sexual function.
  • Category 2:  Products that associate the role of a healthy lifestyle with helping to reduce the risk or impact of chronic diseases or conditions. An important requirement is that it must be “well understood and accepted that healthy lifestyle choices may play an important role in health outcomes for the disease or condition.”  Examples provided by FDA of such chronic diseases include heart disease, high blood pressure, and type 2 diabetes.

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In the Accessories draft guidance “Medical Device Accessories: Defining Accessories and Classification Pathway for New Accessory Types,” FDA seeks to clarify and modify its policy concerning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. 

There is a 90 day public comment period for these guidances. Further analysis of the draft General Wellness Guidance can be found in our client alert, available here.