Tuesday, January 20, 2015

FDA Draft Guidance for General Wellness Devices

Today the FDA released draft guidance on regulation of low-risk "general wellness" devices.  Draft guidance is nonbinding and subject to change, but it does provide a window into the FDA's thinking on a topic of increasing relevance.  This guidance will be part of a compliance policy of the Center for Devices and Radiological Health (CDRH).

This draft guidance continues the FDA's recent trend to state explicitly what they will not be regulating.  In September 2013 the FDA issued final guidance on mobile medical applications where they stated that "The agency intends to exercise enforcement discretion (meaning it will not enforce requirements under the Federal Drug & Cosmetic Act) for the majority of mobile apps as they pose minimal risk to consumers. The FDA intend to focus its regulatory oversight on a subset of mobile medical apps that present a greater risk to patients if they do not work as intended."  My thoughts on that report can be found here.

Then, in August 2014 the FDA issued a draft document detailing their "Intent to Exempt Certain Class II and Class I Reserved Medical Devices from Premarket Notification Requirements" - my thoughts are here.

So it comes as no surprise that this latest draft proposes that "CDRH does not intend to examine low risk general wellness products to determine whether they are devices within the meaning of the FD&C Act."

The document goes on to define "general wellness products as products that:
  1. are intended for only general wellness use, as defined in this guidance, and
  2. present a very low risk to users' safety."
Examples of device categories covered by this guidance include:
  • weight measurement
  • physical fitness, including products intended for recreational use
  • relaxation or stress management
  • mental acuity
  • self-esteem (e.g., devices with a cosmetic function that make claims related only to self-esteem)
  • sleep management
  • sexual function
However, any devices falling into the above categories that are not low risk would not be covered by this guidance.  The risk is determined by whether or not the product:
  1. is invasive
  2. involves an intervention or technology that may pose a risk to a user's safety if device controls are not applied, such as risks from lasers, radiation exposure, or implants
  3. raises novel questions of usability
  4. raises questions of biocompatibility
Finally, to be very clear, the document gives several examples of low risk products, such as a mobile app that plays soothing music to manage stress; a mobile app that monitors daily energy expenditure to increase self-awareness to maintain good cardiovascular health; a mobile app that records food consumption help the user manage dietary activity; a device that monitors pulse during exercise or hiking; and a product that mechanically exfoliates the skin (to increase self-esteem).

I continue to applaud the FDA for giving clear guidelines for mobile apps and devices to help foster an environment ripe for innovation while keeping patients safe.

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