The U.S. Food and Drug Administration has issued two draft guidance documents outlining its current thinking about low-risk devices intended to promote general wellness as well as the regulatory agency’s risk classification approach to medical device accessories.

Under the proposed guidance, general wellness products can include exercise equipment, audio recordings, mobile apps, video games, and other products that are typically available from retail establishments.The FDA would not enforce regulatory compliance for low-risk general wellness devices “designed to maintain or encourage a general state of health” and that “may associate a healthy lifestyle with reducing the risk or impact of certain diseases or conditions.” Through this policy, the agency said it hopes to foster the development of low-risk devices intended to promote a healthy lifestyle.

In separate draft guidance, FDA considers an “accessory” as a medical device that is intended to support, supplement, and/or augment the performance of one or more medical devices. The agency is proposing to “regulate medical device accessories based on the risks they present when used as intended with their parent devices and not based on the risks of their parent devices.” As an example, the agency states that “if a parent device warrants regulation as a Class II device but an accessory to the parent device presents lower risks, we would regulate the accessory as a Class I rather than a Class II device.”

Reactions to the FDA guidance were mixed. In a written statement, Health IT Now’s executive director Joel White said his organization is “disappointed to see the release of FDA guidance attempting to define the regulatory parameters for health IT, not because we disagree with the policy, but 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.”

White argues that the draft guidance “comes at a crossroads for the FDA, as the agency is facing bipartisan legislation moving through both houses of Congress that would clarify the role of the agency with regard to regulating health IT. He asserts that it also “comes on the heels of an Office of the National Coordinator for HIT working group on the FDASIA report, which states that regulation of health IT must be fixed in legislation not regulation because it is ‘broken at the written law level.’”

As a result, Health IT Now is urging the FDA and ONC to “work with legislators in Congress to develop a new regulatory framework that encourages innovation and protects the safety of patients.”

However, Bradley Merrill Thompson, an attorney at Washington, D.C.-based law firm Epstein Becker Green who counsels medical device companies on regulatory issues, has quite a different take on the FDA’s draft guidance.

In particular, Thompson tells Health Data Management that he “loves” the wellness guidance. “No longer does the mere mention of a disease in promotional materials mean that FDA may regulate it,” exclaims Thompson. “FDA has chosen to draw a very common sense line that avoids regulating products that help people manage common chronic diseases. Those are incredibly important extensions of FDA’s policy of enforcement discretion. And indeed, FDA chose to recognize the food and drug law principle of general recognition itself, and the value of reviewing peer-reviewed literature to establish accepted scientific truths.”

At the same time, Thompson—who is also general counsel for the mHealth Regulatory Coalition (MRC)—says that he is “a little less in love” with the FDA’s proposed accessory guidance, observing that “it does not go as far as I’d like to see.” In comments he submitted last year to FDA on behalf of MRC as a part of the FDASIA process, Thompson asked the regulatory agency to “tackle [in their guidance] a few more topics that regrettably they did not tackle.”

Specifically, he wanted FDA to amplify on how to determine whether an item is an accessory that is part of a system. “Complicated systems really complicate the regulatory analysis, and we could use some greater clarity from FDA on the approach to systems,” Thompson says. “We also wanted FDA to shed more light on how it regulates claims associated with an accessory, and the required validation by the accessory product manufacturer.”

Industry and other stakeholders have until April 20 to comment on the two FDA draft guidance documents, after which time the agency will begin work on its final versions.

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