Background

On January 20, 2015, the U.S. Food and Drug Administration (FDA or the Agency) announced the availability of two draft guidance documents in the Federal Register: “General Wellness: Policy for Low Risk Devices” (General Wellness Guidance) and “Medical Device Accessories: Defining Accessories and Classification Pathway for New Accessory Types” (Accessories Guidance).[1] FDA originally committed to issuing the guidance documents in the April 2014 FDASIA Health IT Report.

Per the General Wellness Guidance, FDA is proposing to exercise enforcement discretion for products intended for general wellness only (i.e., products designed to maintain or encourage a general state of health or a healthy activity or that may associate a healthy lifestyle with reducing the risk or impact of certain chronic diseases or conditions). The Agency’s position in the General Wellness Guidance to not regulate general wellness products as medical devices is consistent with its past policy statements on similar products (e.g., general health and wellness apps, exercise equipment for general physical conditioning, and/or for the development of athletic abilities in individuals who lack physical impairment).[2] Significantly, however, FDA attempts to clarify in the General Wellness Guidance where the Agency believes the “wellness” line is drawn. Of some note is FDA’s discussion of wellness products that may help to reduce the risk of or that may help living well with certain chronic diseases or conditions, which is further than the Agency had previously gone and opens the door to a wider range of claims for wellness products.  

According to the Accessories Guidance, FDA is proposing to regulate medical device accessories based on the risks they present when used as intended with their parent devices and not based on the risks of their parent devices. For example, if a parent device is classified as a Class II device, but an accessory to that device presents lower risks, the Agency would regulate the accessory as a Class I device rather than as a Class II device.

What Are General Wellness Products?

For the purposes of the General Wellness Guidance, FDA defines “general wellness products” as products that

  • Are intended for general wellness use only, as defined in the General Wellness Guidance; and
  • Present a very low risk to users’ safety.

General wellness products may include exercise equipment, audio recordings, video games, software programs, and other products that are commonly, although not exclusively, available from retail establishments (including online retailers and distributors that offer directly downloadable software) provided that the above two criteria are met.

For FDA’s General Wellness Guidance to apply to a product, the product must have an intended use that

  • Relates to maintaining or encouraging a general state of health or a healthy activity (but does not make any references to diseases or conditions); or
  • Associates the role of a healthy lifestyle with helping reduce the risk or impact of certain chronic diseases or conditions and where it is well understood and accepted that healthy lifestyle choices may play an important role in health outcomes for the disease or condition.

Classification of Accessory Devices and Parent Devices

The purpose of the Agency’s Accessories Guidance is to clarify and modify its policy concerning the classification of accessories to medical devices and to discuss the application of that policy to specific categories of devices that are commonly used as accessories to other medical devices. FDA is proposing to regulate medical device accessories based on the risks they present when used as intended with their parent devices and not based on the risks of their parent devices.

For the purposes of the Accessories Guidance, FDA defines “accessory” and “parent device” as follows:

  • Accessory: A device that is intended to support, supplement, and/or augment the performance of one or more parent devices.
  • Parent Device: A finished device whose performance is supported, supplemented, and/or augmented by one or more accessories.

FDA issued the Accessories Guidance to clarify how its risk-based and regulatory control–based framework applies to accessory devices and to encourage firms to use the de novo classification process to request risk-based classifications of accessories of a new type.