On April 17, 2018, the Food and Drug Administration (FDA) released its Medical Device Safety Action Plan which outlines FDA’s intended steps to address medical device safety while preserving enough space for innovation in the market.

The FDA’s plan is the latest effort by the FDA on medical device safety, including a recent budget request seeking $70 million to create a Center of Excellence on Digital Health that would, among other things, craft new regulations for third-party certification for developing medical devices. This comes as FDA is pushing guidance and innovative approaches for oversight of digital health (see our blog).

According to FDA Commissioner Scott Gottlieb’s announcement, the FDA’s plan organized into five points that seek to balance patients’ timely access to devices and safety and effectiveness. Continue Reading FDA’s Medical Device Safety Action Plan

In a final guidance document released July 29th, the U.S. Food and Drug Administration (“FDA”) officially confirmed that it does not intend to review or require regulatory compliance for fitness trackers and certain health apps, collectively termed “general wellness products.”  This guidance, which is largely unchanged from the draft guidance issued in January 2015, coincides with FDA’s narrowing oversight of mobile medical apps and related tools.

According to the guidance, general wellness products are:

  1. Products that are intended for “general wellness use” (e.g., weight management, physical activity trackers, and stress management tools); and
  2. Products that present a low risk to the safety of users and others persons.

The primary distinction between a general wellness product and a medical device, which FDA does regulate, is that the intended use of a general wellness product is either to maintain or encourage a general state of health or healthy activity or to support a healthy lifestyle to help reduce the risk or impact of certain chronic conditions where there is a well-known connection. The guidance further explained that although general wellness products may claim to help manage or reduce the risk of certain chronic diseases, they may not claim to treat or diagnose a specific disease or condition.  Products that make these claims are considered medical devices and are subject to FDA regulation.

As mentioned above, this guidance is in line with FDA’s recent policy to exercise enforcement discretion when dealing with products that may help consumers manage or prevent ill health and pose a minimal risk of harm.  The policy attempts to strike a balance between ensuring consumer safety while supporting the rapid pace of innovation that is directed at consumer health.  This guidance along with earlier guidance can help mobile medical app, fitness trackers, wellness tools, and health information technology developers determine how to market their products in light of existing law and should be considered in the early stages of product development and business strategy.

For more information, please contact the authors of this post or your regular Crowell & Moring contact.