FDA Releases Draft Guidance for mHealth, Wellness Devices

The FDA published two draft guidance documents that outline how the agency would classify low-risk general wellness devices and applications and propose risk assessment-based regulation for medical device accessories, Health Data Management reports.

Draft Guidance Details

In one draft guidance, FDA detailed what it would qualify as a low-risk general wellness product, which would not be subject to the agency's regulation. FDA said that general wellness products can include:

  • Audio recordings;
  • Exercise equipment;
  • Mobile apps;
  • Video games; and
  • Other products that tend to be sold by retail establishments (Slabodkin, Health Data Management, 1/19).

Specifically, the draft guidance divided low-risk general wellness products into two categories:

  • Those that do not refer to any diseases or conditions, such as products for weight, sleep or stress management; and
  • Those that might help reduce the risk of or improve living with certain chronic diseases and conditions (Bowman, FierceHealthIT, 1/16).

FDA also provided examples of claims that would subject wellness device developers to FDA regulations and those that would not. For example:

  • Devices that claim to promote or maintain a healthy weight, encourage healthy eating or assist with weight loss would not require FDA oversight; and
  • Those that claim they can treat or diagnose obesity or eating disorders would be subject to regulation (Dolan, MobiHealthNews, 1/16).

Meanwhile, FDA in separate draft guidance defined a medical device accessory as something that is used with at least one parent device or is "intended to support, supplement and/or augment the performance of one or more parent devices."

FDA's draft guidance proposed regulating medical device accessories based on the risks they present when used with their parent devices, but not based on the parent device's risks. The agency noted that some device accessories can have lower associated risks than their parent devices, and thus warrant different levels of regulation (FierceHealthIT, 1/16).

FDA is seeking public comment on the draft guidance documents until April 20.


Stakeholder reaction to FDA's draft guidance documents was mixed, Health Data Management reports (Health Data Management, 1/19).

For example, Joel White -- executive director of the Health IT Now Coalition -- in a statement said the group was "disappointed" with "FDA guidance attempting to define the regulatory parameters for health IT ...  because it continues FDA's reach into new technologies at the same time Congress is working on changes to the FDA's authority in this area." He added, "We urge ... FDA and the [Office of the National Coordinator for Health IT] to develop a new regulatory framework that encourages innovation and protects the safety of patients" (Health IT Now release, 1/17).

Meanwhile, Brad Thompson -- an attorney with Epstein Becker & Green -- said that while the guidance on medical device accessories did not go far enough, "FDA truly listened to the public in crafting" the guidance on general wellness products. Thompson, who also is general counsel for the mHealth Regulatory Coalition, added, "FDA has chosen to draw a very common sense line that avoids regulating products that help people manage common chronic diseases" (FierceHealthIT, 1/16).

Source: iHealthBeat, Tuesday, January 20, 2015

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