A lot of health and wellness professionals invent devices to help their patients and clients live better lives. These devices often supplement the services health and wellness professionals provide. A looming question for these professionals, however, is whether their invention needs approval by the Food and Drug Administration (FDA), or is subject to FDA regulation.
This blog post provides an overview of FDA regulatory compliance issues for medical and wellness devices.
FDA Medical Device Historical Background
In 1976, Congress amended the FDCA with the Medical Device Amendments (MDA). These amendments broadly defined a medical device as follows:
An instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory, which is . . . intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment or prevention of disease. . . or intended to affect the structure or function of the body.
Thus, an important consideration of whether a device is subject to FDA medical device regulation is to determine the device’s “intended use.” To determine the intended use, the FDA looks at a product’s labeling claims, advertising matter, or oral or written statements by manufacturers or their representatives.Generally, products, including software, are considered medical devices if they are intended for a medical purpose. However, software intended for maintaining or encouraging a healthy lifestyle and unrelated to the diagnosis, cure, mitigation, prevention or treatment of a disease or condition is not a device subject to FDA regulation.
If a product is considered a medical device, the manufacturer must comply with certain FDA regulatory requirements. These requirements include:
Products requiring PMAs are Class III devices are high risk devices that pose a significant risk of illness or injury, or devices found not substantially equivalent to Class I and II predicate through the 510(k) process. The PMA process is more involved and includes the submission of clinical data to support claims made for the device. Medical device user fees apply to original PMAs and certain types of PMA supplements. Small businesses are eligible for reduced or waived fees.
See below discussion on the three different classes of devices under FDA regulation.
As referenced above, the FDA regulates three different classes of medical devices. Under this classification system, the FDA determines the amount of pre-market and post-market regulation the FDCA requires. The higher the classification, the more scrutiny the device receives. The three classes of medical devices are as follows:
The FDCA also gives the FDA the authority to set good manufacturing practice requirements for medical devices, to ban worthless and dangerous products from the market, and to require notification, replacement or refund by makers of defective products.
With regard to software, the FDA has long considered software products to meet the definition of a device when the software is intended for use in diagnosing and treating diseases and other conditions. Although the FDA views software products as within the FDCA purview, the FDA announced that it would exercise “enforcement discretion” over many types of low-risk software, such as software that merely provides information. “Enforcement discretion” means that the FDCA applies to the device and the FDA has legal authority to enforce regulations, but it chooses not to enforce those regulations. The take-away regarding FDA regulation of devices is that if the device is intended to diagnose or treat a disease or condition, it is likely that it will be subject to FDA regulation.
Guidance for Mobile Medical Apps and Low Risk Wellness Devices
The FDCA grants the FDA authority to issue regulations as well as allows interested parties to request a public hearing as part of the rulemaking process. The FDCA also includes residual rulemaking authority to address matters not specifically covered by the formal rulemaking provision. This allows the FDA to conduct notice-and-comment procedures for the promulgation of rules. This “informal” rulemaking procedure avoids the burdensome hearing procedure required with formal rulemaking. Yet, even informal rulemaking has become lengthy and difficult for the FDA. As a result, the FDA has resorted to issuing “guidance,” offering the FDA a convenient short cut for communicating its expectations to regulated entities. The guidance process is not without critics, however. A primary criticism is that these informal announcements operate as de facto rules without the normal procedural safeguards that allow for public comment and review. Despite this criticism, the FDA has recently issued guidance documents for both mobile medical apps and low risk wellness devices.
Mobile Medical Apps Guidance
The FDA updated its original guidance relating to mobile medical applications on February 9, 2015. The guidance defines “mobile medical app” as a software application that can be run on a smart phone, tablet or other portable computer, or a web-based software platform tailored to a mobile platform but executed on a server, that meets the definition of device in § 201(h) of the FDCA and either is intended: a) to be used as an accessory to a regulated medical device; or b) to transform a mobile platform into a regulated medical device. Generally, if a mobile app is intended for use in performing a medical device function (i.e., for diagnosis of disease or other conditions, or the cure, mitigation, treatment, or prevention of disease) it is a medical device, regardless of the platform on which it is run.Recall that the FDA looks at a product’s labeling claims, advertising materials or oral or written statements by manufacturers or their representatives to determine a device’s intended use.
The key for wellness professionals and organizations is to determine whether a mobile app constitutes a mobile “medical” app or just a mobile app. If the latter, the FDA will exercise enforcement discretion, which as noted above means the FDA is choosing not to enforce compliance of those apps under the FDCA. If the app is a mobile “medical” app, then the FDA will apply its regulatory oversight over those apps. See Table 10.1 for the apps the FDA considers to be mobile “medical” apps subject to its oversight.  Mobile apps over which the FDA intends to exercise enforcement discretion are listed in Table 10.2. 
Table 1 – Mobile Medical Apps with FDA Regulatory Oversight
|Type of Mobile Medical App||Examples||Must Comply With:|
|Apps that are an extension of one or more medical devices by connecting to such devices for purposes of controlling the devices or for use in active patient monitoring or analyzing medical device data.||· Display of medical images directly from a Picture Archiving and Communication System (PACS) server;
· Remote display of data from bedside monitors;
· Apps that provide the ability to control inflation and deflation of blood pressure cuff;
· Apps that control delivery of insulin on insulin pump by transmitting control signals to the pumps from the mobile platform.
|Regulations applicable to the connected medical device.|
|Apps that transform the mobile platform into a regulated medical device by using attachments, display screens, or sensors or by including functionalities similar to those of currently regulated medical devices.||· Blood glucose strip reader attached to a mobile platform to function as glucose meter
· Attachment of electrocardiograph electrodes to mobile platform to measure, store, and display ECG signals;
· App that uses built-in accelerometer on a mobile platform to collect motion information for monitoring sleep apnea;
· App that uses sensors (internal and external) on a mobile platform for creating electronic stethoscope function;
· App that displays radiological images for diagnosis
|The device classification associated with the transformed platform.|
|Apps that become a regulated medical device (software) by performing patient-specific analysis and providing patient specific diagnosis, or treatment recommendations.||· Apps that use patient-specific parameters and calculate dosage or create a dosage plan for radiation therapy;
· Computer Aided Detection software (CAD) image processing software;
· Radiation therapy treatment planning software.
|The FDA encourages manufacturers of this type of app to contact FDA to discuss what, if any, regulatory requirements may apply.|
Table 2 – Mobile Apps with FDA Enforcement Discretion
|Type of Mobile App||Examples|
|Apps that provide or facilitate supplemental clinical care, by coaching or prompting, to help patients manage their health in their daily environment.||· Apps that coach patients with conditions such as cardiovascular disease, hypertension, diabetes or obesity, and promote strategies for maintaining a healthy weight, getting optimal nutrition, exercising, managing salt intake, or adhering to pre-determined medication dosing schedules by simple prompting.
· Apps that use video and video games to motivate patients to do their physical therapy exercises at home.
· Apps that provide periodic educational information, reminders, or motivational guidance to smokers trying to quit, patients recovering from addiction, or pregnant women.
· Apps that help patients with diagnosed psychiatric conditions (e.g., PTSD, depression, anxiety, OCD) maintain their behavioral coping skills by providing a “Skill of the Day” behavioral technique or audio messages that the user can access when experiencing increased anxiety;
· Apps that prompt a user to enter which herb and drug they would like to take concurrently and provide information about whether interactions have been seen in the literature and a summary of what type of interaction was reported;
· Apps that use patient characteristics such as age, sex, and behavioral risk factors to provide patient-specific screening, counseling and preventive recommendations from well-known and established authorities.
|Apps that provide patients with simple tools to organize and track their health information.||Apps that provide simple tools for patients with specific conditions or chronic disease such as:
· Heart disease
To log, track or trend their events or measurements (e.g., blood pressure measurements, drug intake times, diet, daily routine or emotional state) and share this information with their health care provider as part of a disease-management plan.
|Apps that provide easy access to information related to patients’ health conditions or treatments (beyond providing an electronic “copy” of a medical reference).||· Apps that use a patient’s diagnosis to provide a clinician with best practice treatment guidelines for common illnesses or conditions such as the flu;
· Apps that are drug-drug interaction or drug-allergy look-up tools.
|Apps that are specifically marketed to help patients document, show or communicate to providers potential medical conditions.||· Apps that serve as videoconferencing portals specifically intended for medical use and to enhance communications between patients, healthcare providers, and caregivers;
· Apps specifically intended for medical uses that utilize a mobile device’s built-in camera or a connected camera for purposes of documenting or transmitting pictures (e.g., photos of a patient’s skin lesions or wounds) to supplement or augment what would otherwise be a verbal description in a consultation between or with a healthcare provider.
|Apps that perform simple calculations routinely used in clinical practice.||Medical calculators for:
· Body Mass Index (BMI)
· Total Body Water/Urea Volume of Distribution
· Mean arterial pressure
· Glascow Coma Scale score
· APGAR score
· NIH Stroke Scale
· Delivery date estimator
|Apps that enable individuals to interact with PHR or EHR systems.||Apps that allow patients to gain electronic access to health information stored in a personal health record or electronic health record system.|
|Apps that meet the definition of Medical Device Data Systems.||Apps intended to transfer, store, convert format, and display medical device data, without controlling or altering the functions or parameters of any connected medical device. These apps include those that are used as a secondary display to a regulated medical device when these apps are not intended to provide primary diagnosis, treatment decisions, or to be used in connection with active patient monitoring.|
Regardless of whether a medical device is subject to FDA enforcement authority or is one for which the FDA applies enforcement discretion, the FDA strongly recommends that manufacturers of all mobile apps that may meet the definition of a medical device follow the Quality System regulation in the design and development of those apps. This regulation includes good manufacturing practices. A partial list of these practices are:
In addition to mobile apps that the FDA considers medical devices (and either applies its enforcement authority or does not), there is a third category of mobile apps that the FDA concludes are not medical devices at all and therefore have no regulatory requirements under the FDCA. Examples of these types of apps are listed in Table 10.3.
Table 3 — Apps that are NOT Medical Devices with No FDA Regulatory Requirements
|Type of Mobile App||Examples|
|Apps intended to provide access to electronic “copies” (e.g., e-books, audio books) of medical textbooks or other reference materials with generic text search capabilities. Not intended for use in diagnosis, cure, mitigation, treatment or prevention of disease.||· Medical dictionaries;
· Electronic copies of medical textbooks or literature articles such as the Physician’s Desk Reference or Diagnostic and Statistical Manual of Mental Disorders;
· Library of clinical descriptions for diseases and conditions;
· Encyclopedia of first-aid or emergency care information;
· Medical abbreviations and definitions;
· Translations of medical terms across multiple languages.
|Apps intended for health care providers to use as educational tools for medical training or to reinforce training previously received.||· Medical flash cards with medical images, pictures, graphs;
· Question/Answer quiz apps;
· Interactive anatomy diagrams or videos;
· Surgical training videos;
· Medical board certification or recertification preparation apps;
· Games that simulate various cardiac arrest scenarios to train health professionals in advanced CPR skills.
|Apps intended for general patient education and to facilitate patient access to commonly used reference information.||· Portals for health care providers to distribute educational information (e.g., interactive diagrams, useful links and resources) to their patients regarding their disease, treatment or upcoming procedure;
· Guides for patients to ask appropriate questions to physicians relevant to particular disease, condition or concern;
· Information apps about gluten-free food products or restaurants;
· Apps that match patients with appropriate clinical trials and facilitate communication between patient and clinical trial investigator;
· Tutorials or training videos on how to administer first-aid or CPR;
· Apps that allow users to input pill shape, color or imprint and displays pictures and names of pills that match the description;
· Apps that find the closes medical facilities and doctors to user’s location;
· Apps that provide lists of emergency hotlines and physician/nurse advice lines;
· Apps that provide and compare costs of drugs and medical products at pharmacies in the user’s location.
|Apps that automate general office operations in a health care setting and are not intended for use in the diagnosis, cure, mitigation, treatment or prevention disease.||· Apps that determine billing codes;
· Apps that enable insurance claims data collection and processing;
· Apps that analyze insurance claims for fraud or abuse;
· Apps that perform medical business accounting functions
· Apps that generate reminders for scheduled medical appointments;
· Apps that help patients track, review and pay medical bills online;
· Apps that manage shifts for doctors;
· Apps that manage or schedule hospital rooms or bed spaces;
· Apps that provide wait times and electronic check-in for hospital emergency room or urgent care facilities;
· Apps that allow healthcare providers or staff to process payments;
· Apps that track or perform patient satisfaction surveys after a clinical encounter.
|Apps that are generic aids or general purpose products that are not specifically intended for medical purposes.||· Apps that use the mobile platform as a magnifying glass;
· Apps that use the mobile platform for recording audio, not-taking, replaying audio with amplification;
· Apps that allow patients or healthcare providers to interact through email, web-based platforms, or video;
· Apps that provide maps and turn-by-turn directions to medical facilities (and other locations);
· Apps that allow health care providers to communicate in a secure and protected method.
Guidance for Low Risk Wellness Devices
In addition to mobile apps, wellness professionals and organizations may develop or encounter other products that the FDA considers “low risk” to consumer safety. The FDA released final guidance regarding general wellness products on September 27, 2019. According to the FDA, general wellness products generally promote a healthy lifestyle and meet the following two factors: 1) are intended for only general wellness use; and 2) present a very low risk to users’ safety. General wellness products may include exercise equipment, audio recordings, video games, software programs and other products commonly available form in-person or online retailers.
Intended For General Wellness Only
The FDA defines a general wellness product as one that meets one of the following: 1) has 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.
Importantly, the first category of general wellness product does not make any reference to diseases or conditions. To fall within this category, the general wellness product may relate to:
Examples of general wellness claims that would not be subject to FDA regulation include:
Wellness, exercise or health professionals who invent devices making these types of claims would likely not have to go through FDA scrutiny before marketing their devices, assuming the other wellness device requirements were met.
In contrast, products that relate to the following would not qualify as general wellness products (and therefore could be subject to FDA regulation):
The second category of general wellness products is comprised of two subcategories: 1) intended uses to promote, track, and/or encourage choices, which, as part of a healthy lifestyle, may help to reduce the risk of certain chronic diseases or conditions; and 2) intended uses to promote, track and/or encourage choices which, as a part of a healthy lifestyle, may help living well with certain chronic diseases or conditions. Both subcategories of disease-related wellness products should only make claims about healthy lifestyle choices reducing the risk of chronic disease or a medical condition if those claims are generally accepted and described in peer-reviewed scientific publications. For example, it is generally accepted that a healthy lifestyle reduces the risk of or help better manage heart disease, high blood pressure and type 2 diabetes.
So, if a health or wellness professional invents a device to help manage a chronic disease, or to reduce the risk of a chronic disease, and it is well known that the healthy choice associated with the device helps with that chronic condition, the health or wellness professional can likely avoid FDA regulation. Here are some examples of disease-related general wellness claims that a health or wellness professional may make regarding their invention without subjecting themselves to FDA regulation:
Presents a Very Low Risk to User’s Safety
In addition to being intended for general wellness, in order for a product to qualify as a low risk wellness device, the product must also not present inherent risks to a user’s safety.The FDA considers a product to present an inherent risk to a user’s safety if the product:
Examples of such products include:
Another way to determine whether a wellness device qualifies as low risk is to investigate whether the FDA already regulates products of the same type as the product in question.Wellness professionals and organizations may visit the FDA website at http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm to search for similar products that the FDA might already regulate.
A product that qualifies as a low risk wellness device, however, is not subject to FDA regulation. The FDA does not intend to examine these low risk products to determine whether they are “medical devices” subject to the FDCA or, if they are devices, whether they are in compliance with the FDCA.
Putting it Together
Given the “first category” and “second category” descriptions above of general wellness products, it appears that wearable technology (e.g. FitBit, Jawbone) devices that track data such as exercise and dietary behavior would be considered low risk wellness devices and therefore not subject to any FDA regulatory requirements. They also present a very low risk to the user’s safety as described below. However, if this technology changes in the future (e.g., becomes a medical device that is intended to diagnose and treat a disease), it would be subject to FDA regulations. Therefore, workplace wellness programs that provide wearable technology for their employees may not need to be concerned with these FDA regulations at the moment, but may need to comply with FDA laws as technology changes and moves more into clinical applications. And of course, wellness professionals that use information collecting devices must still address compliance with privacy, confidentiality, and security regulations, as well as state licensing/scope of practice laws.
If you need help with regulatory compliance for medical or wellness devices, contact the Center for Health and Wellness Law, LLC. We are your “go to” resource for wellness legal help.
 Id. at 1085-86 (citing 21 USC § 321(h)) (2012).
 Id. at 1086 (noting that the regulatory language for medical devices and drugs is identical, but that the level of regulation is much less strict for most devices).
 US FDA, General Wellness: Policy for Low Risk Devices, Sept. 27, 2019.
 U.S. Food and Drug Administration, Overview of Device Regulation, Fact Sheet (August 14, 2015) available at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/ (last visited July 9, 2016) (citing 21 CFR Part 807).
 Id. (citing 21 CFR Part 807, Subpart E).
 Id. (citing 21 CFR Part 814).
 Id. (citing 21 CFR Part 812).
 Id. (citing 21 CFR Part 820).
 Id. (citing 21 CFR Part 801).
 Id. (citing 21 CFR Part 803).
 Stephen McInerney, Can You Diagnose Me Now? A Proposal to Modify the FDA’s Regulation of Smartphone Mobile Health Applications with a Pre-Market Notification and Application Database Program, 48 U. Mich. J.L. Reform, 1073, 1086 (2014-2015).
 Cortez, The Mobile Health Revolution, 47 U.C.D.L. Rev., at 1201.
 Cortez, The Mobile Health Revolution, 47 U.C.D.L. Rev., at 1201-02.
 Id. at 1087; see also Cortez, The Mobile Health Revolution, 47 U.C.D.L. Rev., at 1201.
 McInerney, Can You Diagnose Me Now? A Proposal to Modify the FDA’s Regulation of Smartphone Mobile Health Applications with a Pre-Market Notification and Application Database Program, 48 U. Mich. J.L. Reform, at 1087.
 Adam Candeub, Digital Medicine, the FDA, and the First Amendment, 49 Ga. L. Rev. 933, 944 (2014-2015).
McInerney, Can You Diagnose Me Now? A Proposal to Modify the FDA’s Regulation of Smartphone Mobile Health Applications with a Pre-Market Notification and Application Database Program, 48 U. Mich. J.L. Reform, at 1087.
 Id. (citing Medical Device Amendments of 1976, Pub. L. No. 94-295, § 518).
 Id. at 1087-88.
 Id. at 1088.
 Lars Noah, Governance by the Backdoor: Administrative Law(lessness?) at the FDA, 93 Neb. L. Rev. 89, 94 (2014-2015); 21 USC § 371(e).
 Noah, Governance by the Backdoor: Administrative Law(lessness?) at the FDA, 93 Neb. L. Rev. at 94-95; 21 USC § 371(a).
 Noah, Governance by the Backdoor: Administrative Law(lessness?) at the FDA, 93 Neb. L. Rev. at 94-95.
 Id. at 95.
 Id. at 97.
 FDA, Mobile Medical Applications Guidance for Industry and Food and Drug Administration Staff (Feb. 9, 2015), available at http://www.fda.gov/downloads/MedicalDevices/…/UCM263366.pdf (last visited May 20, 2016).
 Id. at 7.
 Id. at 8.
 Id. at 13.
 Id. at 14-15.
 Id. at 16-18; 23.
 Id. at 13.
 21 CFR Part 820.
 FDA, Mobile Medical Applications Guidance for Industry and Food and Drug Administration Staff, at 20 (Feb. 9, 2015), available at http://www.fda.gov/downloads/MedicalDevices/…/UCM263366.pdf (last visited May 20, 2016).
 Id. at 20-22.
 FDA, General Wellness: Policy for Low Risk Devices, Guidance for Industry and Food and Drug Administration Staff (September 27, 2019), available at http://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm429674.pdf (last visited December 3, 2020).
 Id. at 1-2.
 Id. at 2-3.
 Id. at 3.
 Id. at 4.
 Id. at 4.
 Id. at 5.
 Id. at 6.
 Id. at 5.
 Id. at 2.