On January 16, 2015, the Food and Drug Administration (FDA) released two draft guidances, both of which were included in the Center for Devices and Radiological Health’s (CDRH) “A-list” of priority guidances to be released in 2015. The first of these draft guidances,General Wellness: Policy for Low Risk Devices, (General Wellness Draft Guidance) seeks to clarify the FDA’s compliance policy for low-risk products that are limited to promoting a healthy lifestyle. The second draft guidance, Medical Device Accessories: Defining Accessories and Classification Pathway for New Accessory Types, (Accessory Draft Guidance) is intended to clarify and modify the FDA’s policy on the classification of medical device accessories, and to encourage use of the de novo classification pathway to marketing clearance of new types of accessories.
Both draft guidances, while general in scope and not limited to any one type of device or class of devices, cover topics specifically referenced in the April 3, 2014, FDASIA Health IT Report: Proposed Strategy and Recommendations for a Risk-Based Framework, released jointly by the FDA, the Federal Communications Commission (FCC), and the HHS Office of the National Coordinator for Health Information Technology (ONC), as areas in need of further clarity in the development of a risk-based framework for the regulation of Health IT generally, including mobile health products. The other key area identified in the FDASIA report where further clarification in the mobile health space would be particularly helpful is the regulation of clinical decision support (CDS) products. The FDA has yet to release a CDS guidance, but this is another guidance identified in the CDRH's priority list for 2015.
General Wellness Products Would Not Be Regulated as Medical Devices
The General Wellness Draft Guidance clarifies that the FDA does not intend to examine low-risk general wellness products to determine whether they are devices under the Federal Food, Drug and Cosmetic Act (FD&C Act), or, if they are devices, to determine whether they comply with the requisite pre- and post-market regulatory requirements.
In order to qualify as a low-risk general wellness product under this policy, the product must be intended only for general wellness use, and it must pose a very low risk to user safety. The guidance includes a simple decision algorithm to assist companies in determining whether their product is a low-risk general wellness product subject to this policy.
Specifically, the policy defines two types of intended uses that would qualify as general wellness uses:
Products that relate to promoting a general state of health or a healthy activity.
- This would include claims that do not reference any specific disease or condition, but rather discuss general improvement to functions associated with a state of health, e.g., claims that focus on weight management, physical fitness, relaxation, mental acuity, self-esteem, sleep management, or sexual function.
- By contrast, a claim that a product diagnoses or treats a particular condition related to these functions, such as an indication that a product helps to manage stress in order to control an anxiety disorder, would not qualify as a general wellness claim and would be subject to standard FDA regulation.
Products that link a healthy lifestyle with helping to reduce the risk or impact of a chronic disease or condition, where it is well accepted – i.e., according to peer-reviewed scientific literature – that a healthy lifestyle plays a role in health outcomes for the disease or condition.
This would include uses that promote, track, or encourage healthy lifestyle choices that may help reduce the risk of certain chronic diseases or conditions or may help an individual to live well with such a condition. The draft guidance presents heart disease, high blood pressure, and type 2 diabetes as examples of chronic conditions where healthy lifestyles are recognized as potentially reducing risk and the impact of the disease.
Even if a product meets one of the two qualifying intended uses, under the policy, the exemption from regulation will not apply if the device poses inherent risks to a user’s safety. The agency explains that if a device is invasive, involves a technology that may pose a risk to user’s safety if device controls are not applied (e.g., lasers), raises novel questions of usability, or raises questions of biocompatibility, it is not considered a low-risk general wellness product. For example, a sunlamp product indicated for tanning poses risks to user safety from the ultraviolet radiation, and therefore would not be covered by this guidance. The FDA recommends that in making this determination, companies consider whether the CDRH actively regulates products of the same type as the one at issue.
Risk-Based Classification of Accessories
Historically, all accessories to a medical device, unless separately classified, were placed into the same risk classification as the parent device. Thus, an accessory to a high-risk medical device was also considered high risk, regardless of the actual risk posed by the accessory itself. As part of the FDASIA Health IT Report noted above and the FDA’s prior guidance on Mobile Medical Applications, the FDA and industry highlighted the need to potentially classify more accessories in different classes than the parent devices. For example, while a continuous glucose monitor may be considered high risk by the agency (i.e., Class III), an app that pairs with that device to provide historical (i.e., non-real time) views of the data may be much lower risk.
The Accessories Draft Guidance clarifies what the FDA intends to consider as an accessory, and discusses how the agency intends to regulate new accessory types that have not been previously classified. This guidance applies to the regulation of accessories, which are defined as devices that are intended to support, supplement, and/or augment the performance of one or more separate finished devices.
Consistent with current agency policy, in classifying an accessory, the agency must first determine that the device meets the definition of an accessory. To that end, the agency looks to labeling, promotional materials, or other evidence of intended use for the potential accessory (not the parent device), that shows that an article is intended for use with a finished device (whether a particular brand or a device type), and assesses whether the product is intended to support, supplement, and/or augment the finished device’s performance. If so, the device is regulated as an accessory. After the agency determines that a device meets the definition of an accessory, classification will depend on the accessory’s risk when used as intended with the parent device, and the level of regulatory controls necessary to provide a reasonable assurance of safety and effectiveness. This analysis will involve consideration of the risks created by the accessory’s impact on the parent device and any unique, independent risks of the accessory.
The FDA also recommends that manufacturers utilize the de novo classification process under Section 513(f)(2) of the FD&C Act as a path to market for new accessory types where there is no legally marketed predicate device. Technically, accessory devices would typically default to the classification of the parent device or to Class III. Through the de novo process, the agency can classify an accessory as Class I if general controls suffice to provide a reasonable assurance of safety and effectiveness, or as Class II if general and special controls together provide such assurance. For accessories of a type that have already been classified, manufacturers may seek reclassification or exemption from the requirement to submit a 510(k) premarket notification.
The Accessories Draft Guidance also provides an appendix with a summary of the information expected in a de novo request for a new type of accessory, which includes a description of the accessory device and detailed information and reasons for the recommended classification, as well as an executive summary document containing proposed identification language for a new classification regulation or order, a summary of the performance data to support the proposed classification, and risk and mitigation information. As with other de novo petitions, the FDA has 120 days of review time (not including any time the sponsor spends responding to questions) to make a decision. If the de novo is granted, the accessory can then be legally marketed in Class I or Class II and serve as a predicate device for future 510(k)s; if the de novo is declined, the accessory remains in Class III and cannot be marketed without PMA approval.
While this draft guidance generally captures existing FDA policy, it also emphasizes the agency’s willingness to consider downclassification for accessory devices that would typically fall into Class III or otherwise be subject to premarket requirements that are not appropriate given the specific risks presented by the accessory. In providing this written draft policy, the agency recognizes that the regulation of an accessory device should depend on the risk the accessory itself poses when used as intended, rather than on the risks of the corresponding parent device. It remains to be seen, however, whether this new policy, which proposes to focus the assessment of risk on the accessory, will lead to a measurable loosening in the regulatory classification of accessories in practice.
The release of these two draft guidance documents potentially has implications for a broad range of device types, but is also targeted at addressing concerns expressed in the mobile health space. Mobile health and Health IT generally have presented more potential for overlap between traditional medical device functionality and general wellness products. In addition, many new products in the mobile health arena are actually functioning as accessories to more traditional medical devices. In this vein, some of the key takeaways are as follows:
General Wellness Draft Guidance:
- Somewhat surprisingly, the draft guidance provides for the deregulation of wellness products even where they are tied to a specific disease state. Historically, the FDA’s category of general wellness products had been thought to focus on products intended for average-health individuals, rather than patients with specific disease conditions. However, the draft guidance goes one step further and allows for intended uses that include reducing risk or impact associated with chronic diseases.
- The draft guidance is also consistent with the FDA’s prior guidance on Mobile Medical Apps as it relates to software products intended for individuals to log, record, track, evaluate, or make decisions or behavioral suggestions related to developing or maintaining general fitness, health or wellness. However, even if an app trips the limited definition of a general wellness product, under the MMA Guidance, the product may still fall into a separate “enforcement discretion” bucket. That guidance outlines enforcement discretion policies for other types of low-risk mobile health products.
- Beyond heart disease, high blood pressure, and type 2 diabetes, the extent of what will be considered well-accepted, established links between a healthy lifestyle and reducing the risk or impact of other chronic diseases or conditions is less clear. Heart disease, high blood pressure, and type 2 diabetes are the focus of a large part of the current consumer-focused products in the mobile health space. However, there are certainly other medical areas where it is well understood that health lifestyles may reduce risk or impact of the condition. It is not clear in the FDA’s draft guidance what level of evidence would be needed to establish such a link.
Accessories Draft Guidance:
- The FDA’s draft guidance should technically allow for more wide-spread reclassification of new accessory types based on an assessment of the risks presented by the accessory, as opposed to the regulatory classification of the parent device. The draft guidance specifically states that determining the risks of the accessory “does not mean that all risks of a parent device will be imputed to the accessory….” Whether the agency will consistently limit the risk assessment along these lines remains to be seen, but the policy should theoretically provide an avenue for various types of mobile medical app accessories to higher risk products to perhaps avoid classification by imputation.
- While specifically on the radar of the Health IT industry and noted in the FDASIA report as an area where further clarity would be beneficial, regulation of accessories is potentially important beyond this space. The draft guidance does not specifically mention or provide examples in the Health IT space, indicating that the FDA views this as a broader policy.
- The draft guidance proposes to utilize the existing de novo path way for classification of new accessory types, but with several references to a streamlined submission and evaluation process. While the 120-day review timeframe remains consistent with standard de novo classifications, it is unclear from the draft guidance whether and how the de novo process for accessories would be further improved. For example, de novo submissions are often associated with a need for clinical data. It is unclear whether the agency anticipates modified expectations in terms of the type or amount of data required for clearance.
The public comment period for both draft guidances will remain open until April 20, 2015, 90 days from their publication in the Federal Register. Electronic comments should be submitted to http://www.regulations.gov