On January 16, 2015, FDA issued two draft guidance documents: “General Wellness: Policy for Low Risk Devices,” which recommends a hands-off approach for certain low-risk, health IT products and “Medical Device Accessories: Defining Accessories and Classification Pathway for New Accessory Types,” which announces a departure from FDA’s current policy of classifying, and in many cases “up-classifying,” medical device accessories as the same classification as their “parent” devices.
FDA’s approach in the first guidance is not unexpected, given FDA’s current enforcement policy on mobile health products, articulated in Mobile Medical Applications (Sept. 25, 2013). Nevertheless, the draft guidance provides some level of comfort to manufacturers of popular mobile health devices — such as fitness bands and watches — that their products will not be subject to FDA scrutiny. The second guidance proposes a new definition of “accessory” and describes a practical, risk-based policy for classifying device accessories, potentially creating a more expeditious and less onerous path to market device accessory products.
Health IT: General Wellness Products Not Subject to FDA Regulation
In the draft guidance, FDA states that it does not intend to examine low risk “general wellness” products to determine whether they are devices within the meaning of the Federal Food, Drug and Cosmetic Act (FDCA) or, if they are devices, whether they comply with premarket or post-market regulatory requirements under the FDCA and implementing regulations.
The draft guidance describes two categories of general wellness products:
- Products with an intended use that relates to maintaining or encouraging a general state of health or a healthy activity; and
- Products with 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 “where it is well understood and accepted that healthy lifestyle choices may play an important role in health outcomes for the disease or condition.”
Examples of products in the first category include those with claims related to weight management, relaxation or stress management, mental acuity, sleep management or physical fitness. “Health and wellness” mobile apps, such as apps that actively monitor exercise activity or calculate calories burned in a workout, would fall into this category, as would wearable fitness devices — such as bands or watches — that perform similar functions. Products in the second category include those with intended uses to promote, track or encourage choices, which, as part of a healthy lifestyle, “may help to reduce the risk of” or “may help living well with” certain chronic diseases or conditions. It is unclear which chronic diseases or conditions — other than high blood pressure, heart disease and type 2 diabetes, which are specifically mentioned in the guidance — can be included in the product claims, or how far the product claims can depart from example claims provided in the draft guidance. Products that claim to specifically treat or diagnoses diseases would not fall under the draft guidance.
“Low risk” devices would not include products that represent inherent risks to a user’s safety, invasive devices (products that penetrate or pierce the skin) or devices that raise novel questions of usability or questions of biocompatibility.
Medical Device Accessories: Classification No Longer Tied To Parent Product
FDA acknowledges that while classifying an accessory in the same class as its parent may be appropriate in some circumstances, some accessories may have a lower risk profile than their parent device and thus may warrant a lower classification. Under the draft guidance, FDA will determine the risk posed by an accessory device and the controls necessary to assure its safety and effectiveness according to its intended use using the same approach as for non-accessory devices. Because an accessory is intended for use with a parent device, the assessment will be based on the risk of the accessory when used as intended with its parent device.
The draft guidance introduces a new definition of a medical device “accessory,” a term not defined in the FDCA or implementing regulations. Under the draft guidance, an accessory is “a device that is intended to support, supplement and/or augment the performance of one or more parent devices.” By announcing a new definition in the draft guidance, FDA potentially is bypassing the traditional notice-and-comment rulemaking process. FDA has taken a similar approach to its regulation of software, including mobile medical apps, by issuing a series of guidance documents that describe how FDA intends to regulate software products. (See Mobile Medical Applications (Sept. 25, 2013) and Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices (Draft Guidance, Jun. 20, 2014)).
FDA encourages manufacturers of new accessory types to use the de novo classification process in FDCA Section 513(f)(2) to request risk-based review of new accessory types. Accessories within a device type that already has been classified are not eligible for classification through the de novo process. Manufacturers of such devices may seek reclassification or an exemption from 510(k) requirements under applicable sections of the FDCA.
The draft guidance documents are in response to specific recommendations in the FDASIA Health IT Report (Apr. 3, 2014), which requested FDA to provide greater clarity on several aspects of device regulation, including the distinction between wellness and disease-related claims and regulation of medical device accessories.