Mobile Medical Applications (Apps), including General Wellness Products, can help people manage their own health and wellness, promote healthy living and gain access to useful information when and where they need it.
These products are integral parts of our lives, both at leisure and at work. They are all around us and sometimes literally on us, as we can wear them too.
It is hardly an exaggeration to say that mobile medical apps and general wellness products have become our extended phenotype.
We have decided to provide some general background information about the Regulation of Mobile Medical Apps and General Wellness Products in today’s post.
What are Mobile Applications (Mobile Apps)?
FDA Guidance on Mobile Medical Apps defines a mobile application or “mobile app” – as a software application that can be executed (run) on a mobile platform (i.e., a handheld commercial off-the-shelf computing platform, with or without wireless connectivity), or a web-based software application that is tailored to a mobile platform but is executed on a server.
What are Mobile Medical Applications (Mobile Medical Apps)?
The same mobile medical app guidance defines a mobile medical app as a mobile app that meets the definition of device in section 201(h) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and either is intended:
- to be used as an accessory to a regulated medical device; or
- to transform a mobile platform into a regulated medical device.
A device is defined as:
“an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is:
- recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them,
- intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or
- intended to affect the structure or any function of the body of man or other animals, and which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of any of its primary intended purposes.”
Please note that the 21st Century Cures Act (Sec. 3060. Clarifying Medical Software Regulation) has recently (December, 2016) amended the definition of “device” in the Food, Drug and Cosmetic Act to exclude certain software functions, including some described in Mobile Medical Applications guidance document.
According to this Act,
“(1) The term device, as defined in section 201(h), shall not include a software function that is intended—
- “(A) for administrative support of a health care facility, including the processing and maintenance of financial records, claims or billing information, appointment schedules, business analytics, information about patient populations, admissions, practice and inventory management, analysis of historical claims data to predict future utilization or cost-effectiveness, determination of health benefit eligibility, population health management, and laboratory workflow;
- “(B) for maintaining or encouraging a healthy lifestyle and is unrelated to the diagnosis, cure, mitigation, prevention, or treatment of a disease or condition;
- “(C) to serve as electronic patient records, including patient-provided information, to the extent that such records are intended to transfer, store, convert formats, or display the equivalent of a paper medical chart, so long as—
- “(i) such records were created, stored, transferred, or reviewed by health care professionals, or by individuals working under supervision of such professionals;
- “(ii) such records are part of health information technology that is certified under section 3001(c)(5) of the Public Health Service Act; and
- “(iii) such function is not intended to interpret or analyze patient records, including medical image data, for the purpose of the diagnosis, cure, mitigation, prevention, or treatment of a disease or condition;
- “(D) for transferring, storing, converting formats, or displaying clinical laboratory test or other device data and results, findings by a health care professional with respect to such data and results, general information about such findings, and general background information about such laboratory test or other device, unless such function is intended to interpret or analyze clinical laboratory test or other device data, results, and findings; or
- “(E) unless the function is intended to acquire, process, or analyze a medical image or a signal from an in vitro diagnostic device or a pattern or signal from a signal acquisition system, for the purpose of—
- “(i) displaying, analyzing, or printing medical information about a patient or other medical information (such as peer-reviewed clinical studies and clinical practice guidelines);
- “(ii) supporting or providing recommendations to a health care professional about prevention, diagnosis, or treatment of a disease or condition; and
- “(iii) enabling such health care professional to independently review the basis for such recommendations that such software presents so that it is not the intent that such health care professional rely primarily on any of such recommendations to make a clinical diagnosis or treatment decision regarding an individual patient.
It is also notable that the Act includes other more broadly worded language that allows FDA to reach excluded software products when:
- Assessing the safety and effectiveness of a device with multiple functions, where at least one software function is an excluded category and at least one software function meets the device definition (FDCA § 520(o)(2));
- Use of the software function would be reasonably likely to have a serious adverse health consequence;
- The software is used in the manufacture and transfusion of blood and blood components to assist in the prevention of disease; or
- The software meets the definition of a Class III device under FDCA § 513(a)(1)(C).
How FDA regulates Mobile Medical Apps?
The FDA applies the same risk-based approach that the agency uses to assure safety and effectiveness for other medical devices. The Mobile Medical Applications (MMA) guidance provides examples of how the FDA might regulate certain moderate-risk (Class II) and high-risk (Class III) mobile medical apps. The guidance also provides examples of mobile apps that are not medical devices, mobile apps that the FDA intends to exercise enforcement discretion and mobile medical apps that the FDA will regulate.
Mobile Apps for which the FDA intends to exercise Enforcement Discretion
Appendix B of the Mobile Medical Applications guidance provides examples of mobile apps that may meet the definition of a medical device but for which FDA intends to exercise enforcement discretion. These mobile apps may be intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease.
Even though these mobile apps may meet the definition of a medical device, FDA intends to exercise enforcement discretion for these mobile apps because they pose a lower risk to the public.
For such devices, FDA will not expect manufacturers to submit premarket review applications or to register and list their apps with the FDA. Among others, this group includes medical mobile apps that:
- Help patients/users self-manage their disease or condition without providing specific treatment suggestions;
- Provide patients with simple tools to organize and track their health information;
- Provide easy access to information related to health conditions or treatments;
- Help patients document, show or communicate potential medical conditions to health care providers;
- Automate simple tasks for health care providers; or
- Enable patients or providers to interact with Personal Health Records (PHR) or Electronic Health Record (EHR) systems.
Mobile Medical Apps that FDA will regulate
The FDA is taking a tailored, risk-based approach that focuses on the small subset of mobile apps that meet the regulatory definition of “device” and that: are intended to be used as an accessory to a regulated medical device, or transform a mobile platform into a regulated medical device.
These MMAs are included in Appendix C of the guidance (Examples of mobile apps that are the focus of FDA’s regulatory oversight).
You can also find examples of MMAs that FDA regulates on the FDA website.
General Wellness Products
As discussed above, Section 3060 (Clarifying Medical Software Regulation) of FDA 21st Century Cures Act excludes from the medical device definition a software function that is intended: for maintaining or encouraging a healthy lifestyle and is unrelated to the diagnosis, cure, mitigation, prevention, or treatment of a disease or condition;
This and other related categories are well explained in FDA guidance completed in July, 2016 – General Wellness: Policy for Low Risk Devices.
In this guidance, FDA defines general wellness products as products that are intended for the general wellness use and present a very low risk to the users’ safety.
This guidance only applies for the low-risk devices, leaving all other products (e.g., drugs, biologics, dietary supplements, foods, or cosmetics) outside the guidance scope.
In order to qualify as low risk, the product must not be
- involve an intervention or technology that may pose a risk to users’ safety (such as lasers, radiation exposure, or implants);
- raise novel questions of usability; or
- raise questions of biocompatibility
FDA proclaims that it does not intend to examine low risk general wellness products to determine whether they are devices within the meaning of the FD&C Act or, if they are devices, whether they comply with the premarket review and post-market regulatory requirements and implementing regulations such as: registration and listing and premarket notification requirements; labeling requirements; GMP requirements and Medical Device Reporting requirements.
In a nutshell – low risk general wellness products are basically “regulation-free”.
A general wellness product, as defined in the guidance, has (1) an intended use that relates to maintaining or encouraging a general state of health or a healthy activity, or (2) 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.
The first category includes products whose intended uses involve claims “about sustaining or offering general improvement to conditions and functions associated with a general state of health that do not make any reference to diseases or conditions”. Such claims could include, for example, weight management, physical fitness, relaxation or stress management, self-esteem promotion, sleep management or improvement of sexual performance.
The second category of general wellness products is more attractive as it can make references to certain chronic diseases or conditions.
This category is subdivided in two subcategories:
- intended uses to promote, track, and/or encourage choice(s) which, as part of a healthy lifestyle, may help to reduce the risk of certain chronic diseases or conditions; and
- intended uses to promote, track, and/or encourage choice(s) which, as part of a healthy lifestyle, may help living well with certain chronic diseases or conditions.
According to the FDA, manufacturers of devices that fall into these subcategories may make claims that using the product may help reduce the risk of disease, or help someone live better should they suffer from a certain disease or condition.
Such claims are significant as they could provide many more promotional opportunities to general wellness products.
FDA, however, emphasizes that both subcategories of disease-related general wellness claims should only be promoted where it is well understood and generally accepted that healthy lifestyle choices may reduce the risk or impact of a chronic disease or medical condition. The guidance further explains that “such associations are typically described in peer-reviewed scientific publications”.
FDA presents several examples of this category of disease-related general wellness claims:
- Product X promotes physical activity which, as part of a healthy lifestyle, may help reduce the risk of high blood pressure.
- Software Product Y tracks your calorific intake and helps you to manage a healthy eating plan to maintain a healthy weight and balanced diet. Healthy weight and balanced diet may help living well with high blood pressure and type 2 diabetes.
- Product Z tracks activity sleep patterns and promotes healthy sleep habits which, as part of a healthy lifestyle, may help reduce the risk of developing type 2 diabetes.
The FDA specifically lists exercise equipment, video games, software programs, and other products as examples of devices likely to be included within the above definition of a general wellness product.
The new guidance also includes a useful decision algorithm so that manufacturers can determine if their product qualifies as a general wellness product.
Likely impact of General Wellness: Policy for Low Risk Devices Guidance
The change presented by the guidance is remarkable.
Now, general wellness device manufacturers are able to say much more about the well-known health benefits of their products without risking FDA regulation.
The possibility to claim that the product may help mitigate or reduce the risk of certain diseases may provide a strong marketing push for general wellness products which can prove a well understood and accepted association of healthy lifestyle to the improved outcome.
A new, favorable regulatory climate for general wellness products could further promote this industry and bring many new products to the market.
If you need legal advice regarding mobile applications or general wellness products, please don’t hesitate to contact us.