Courtney A. Stevens, Esq. | Senior Attorney, Medmarc Loss Control
On Friday, January 16, the Food and Drug Administration published two draft guidances pursuant to its FDASIA-mandated Health IT Report, released in April of last year: (1) General Wellness: Policy for Low Risk Devices; and (2) Medical Device Accessories: Defining Accessories and Classification Pathways for New Accessory Types. This post discusses the first.
General Wellness Products
The first draft guidance, General Wellness: Policy for Low Risk Devices, does very little in the way of policy. Rather, the majority of the Guidance is devoted to defining what general wellness products are and helping industry determine whether their devices fall under this policy.
The main thrust of the Guidance is that the FDA will not examine general wellness products for safety or compliance. But, it is up to industry to determine whether their products are indeed immune from FDA’s examination as true general wellness products.
To assist in this determination, the Guidance goes on to define “general wellness products” as those products that (1) have an intended use that relates to (a) maintaining or encouraging a general state of health or a healthy activity, or (b) an intended use claim that associates the role of healthy lifestyle with helping to reduce the risk or impact of certain chronic diseases or conditions; and (2) present a very low risk to users’ safety.
Examples of general wellness products under the first category of intended use ((a) as described above) are given as products intended to assist with, e.g., weight management, relaxation, or sleep management. General wellness products that fall into the second category ((b), above) are generally those that, as part of a healthy lifestyle, may help to either reduce the risk or help living with certain chronic disease or conditions. To satisfy the “low risk” prong of the definition of general wellness products, the device must not:
- Be invasive;
- Involve an intervention or technology that may pose a risk to a user’s safety if device controls are not applied, such as risks from lasers, radiation exposure, or implants;
- Raise novel questions of usability; or
- Raise questions of biocompatibility.
Finally, the Guidance provides a decision tree to walk manufacturers through the process of determining whether their products are general wellness products.
Importantly, the Guidance acknowledges that general wellness products can include software, video games, and other consumer technology. Developers of so-called medical mobile apps should certainly utilize the decision tree to determine if their applications may fall under Guidance.
The FDA’s stance on general wellness products, as expressed in this guidance, does not represent a new policy or interpretation by the Agency, but it does provide some much-needed clarity for industry.