FDA Releases Two Draft Guidance Documents on Internet-Connected Medical Devices and Accessories

According to Health Data Management, last Friday the FDA released two draft guidance documents outlining how agencies should distinguish low-risk general health and medical devices and applications, and providing foundational recommendations for risk assessment of medical device accessories. Some observers believe this move signals the FDA’s intent to strengthen regulatory oversight of internet-based healthcare apps, devices, and their accessories.

Details of the Draft Guidance

In one of its draft guidance documents, the FDA detailed the criteria for determining low-risk general wellness products. The FDA stipulated that general wellness products may include:

• Recording equipment;
• Exercise equipment;
• Mobile App;
• Video games;
• Other products sold by retailers;

This draft guidance also categorizes low-risk general medical and health products into two major classes:

• Unrelated to the treatment of any disease, such as products for weight, sleep, and stress management;
• Products that can reduce the risk of disease or improve the quality of life and symptoms for patients with chronic diseases;

The FDA also clarified the scenarios that are subject to FDA regulatory oversight and those that are not, for example:

• Devices that market themselves as capable of helping users improve and maintain a healthy weight, promote evidence-based dietary practices, and assist with weight loss are not subject to FDA regulatory oversight;
• Devices marketed as capable of treating or diagnosing obesity and eating disorders will be subject to FDA regulatory oversight;

Meanwhile, in a separate draft guidance, the FDA defines an accessory to a medical device as a device that is intended to be used with at least one parent device or can be used to support, supplement, or enhance the performance of one or more parent devices.

The FDA’s draft guidance proposes that the risk classification of medical device accessories should be assessed based on their use with the parent device, rather than when the parent device is used alone. The FDA also emphasizes that certain accessories may reduce risks when used with the parent device, thereby necessitating the establishment of varying levels of regulatory oversight.

The FDA is currently soliciting comments on the draft guidance, with a deadline of April 20.

Reactions from Relevant Parties

Reactions to the draft guidance varied widely among stakeholders. For instance, Joel White, Executive Director of the Health IT Now Coalition, expressed deep disappointment with the FDA’s draft guidance, arguing that it seeks to define and restrict internet-based healthcare. He contended that the FDA and the Office of the National Coordinator for Health IT (ONC) should jointly establish a new regulatory framework that encourages innovation while safeguarding user safety.

Meanwhile, Brad Thompson, an attorney at Epstein Becker & Green and legal counsel to the mHealth Regulatory Coalition, argued that the draft guidelines fall far short in regulating medical device accessories. He contended that the FDA should strengthen regulations and oversight of medical device accessories with a greater emphasis on safeguarding public safety.