The U.S. Food and Drug Administration (“FDA”) recently issued draft guidance that directly affects health information technology (“Health IT”), specifically medical device accessories and general wellness products. The new draft guidance for medical device accessories proposes delinking a new accessory’s risk classification from the risk classification of the parent device if appropriate. The new general wellness guidance indicates that the FDA does not plan to regulate general wellness products that are intended for general wellness use and present a low risk to users. Together, these two proposals indicate the FDA’s intent to lower regulatory requirements for certain Health IT products.
The draft guidance follows the FDA’s ongoing development of a framework for the regulation of software. In April 2014, the Health IT Committee Workgroup, which included representatives from FDA, the Office of the National Coordinator for Health Information Technology, the Federal Communications Commission, and private industry stakeholders, requested that FDA provide greater clarity related to several aspects of medical device regulation involving Health IT, including: (1) the distinction between wellness and disease-related claims; (2) medical device accessories; (3) medical device clinical decision support software; (4) medical device software modules; and (5) mobile medical apps. The recent guidance appears to address several of these areas.
The FDA medical device accessory guidance proposes that certain new medical device accessories may be evaluated separately from their parent device. The draft guidance defines an accessory as a “device that is intended to support, supplement, and/or augment the performance of one or more parent devices.” A Health IT medical device accessory could include, for example, mobile apps that provide the ability to control a medical device from a mobile platform (e.g., control inflation or deflation of a blood pressure cuff or delivery of insulin on an insulin pump). Accessory devices can present varying risks to patients. Consequently, where a device accessory is of a lower risk than its parent device, the draft guidance proposes to permit the accessory to be classified at a lower risk than the parent device, using the de novo process.
The FDA general wellness draft guidance indicates that the FDA does not intended to regulate general wellness products. The FDA’s Center for Devices and Radiological Health (“CDRH”) defines general wellness products as those that (1) are intended for only general wellness use, as defined in the guidance; and (2) present a very low risk to users’ safety. This may include exercise equipment, audio recordings, video games, software programs, and other products that are commonly, though not exclusively, available from retail establishments (including online retailers and distributors that offer software to be directly downloaded). A popular example is activity trackers such as the Fitbit. General wellness products do not include tanning beds, implants, or laser treatment for skin.
Ultimately, the FDA’s draft guidance takes a step toward lowering regulatory requirements for certain Health IT products. Manufacturers and other stakeholders are encouraged to comment on the draft guidance by April 20, 2015 to identify areas of agreement and disagreement, and to request additional clarification. Final guidance is not likely to be issued until later this year or in 2016.