On January 16, 2015, the U.S. Food and Drug Administration (FDA) posted a draft guidance document outlining the FDA’s proposed approach to the regulation of general wellness devices (Draft General Wellness Guidance) under the Federal Food Drug and Cosmetic Act (FD&C Act), and a separate draft guidance document regarding its approach to the regulation of medical device accessories (Draft Accessories Guidance) under the FD&C Act.
Although the draft guidance documents apply to a broad range of medical devices, they are notable because they are the latest in a series of FDA guidance documents intended to address mobile health applications and other health information technology (IT). These draft guidance documents follow on the heels of the FDA’s 2013 final guidance on the regulation of mobile medical applications, and 2014’s health IT report pursuant to the Food and Drug Administration Safety and Innovation Act (FDASIA) and draft guidance announcing enforcement discretion for manufacturers of medical device data systems.
The draft guidance documents address two of the five topics on which the FDASIA Health IT Working Group recommended that the FDA provide greater clarity regarding the extent to which a particular mobile medical application or other medical product will be subject to FDA’s medical device regulatory oversight and controls. The guidance thus provides insights to software developers, manufacturers and other stakeholders that wish to design mobile applications and other health IT products in a manner that avoids the need for time-consuming and expensive premarket filings and related regulatory requirements.
Stakeholders should consider submitting comments to the FDA regarding the draft guidance documents. The official comment period for both draft guidance documents closes on April 20, 2015.
This On the Subject addresses the following key issues raised by the guidance documents:
In the Draft General Wellness Guidance:
What is a “general wellness product”?
How would a product with a general wellness use be regulated if it falls outside the draft guidance (i.e., because it is not deemed low risk)?
In the Draft Accessories Guidance:
What is a medical device “accessory”?
How does the FDA propose to classify medical device accessories?
What FD&C Act regulatory requirements apply to the potential classifications of accessories?
Draft General Wellness Guidance
The Draft General Wellness Guidance states that the FDA does not intend to regulate low-risk “general wellness products” as devices under the FD&C Act. Even if a low-risk general wellness product might meet the statutory definition of a “device,” the FDA does not intend to assess whether a general wellness product’s sponsor complies with the regulatory requirements applicable to device manufacturers (e.g., registration and listing, premarket notification, labeling, good manufacturing practice requirements and medical device reporting).
What is a general wellness product?
The Draft General Wellness Guidance defines a general wellness product as a product that meets both of the following criteria:
It is intended only for general wellness use.
It presents a very low risk to user safety.
What is a general wellness use?
For the purposes of the first criterion, a general wellness use is an intended use that either relates to maintaining or encouraging a general state of health or a healthy activity, or associates the role of a healthy lifestyle with helping to reduce the risk or impact of certain chronic diseases or conditions where it is well understood and accepted that healthy lifestyle choices may play an important role in health outcomes for the disease or condition.
A product’s intended use “relates to maintaining or encouraging a general state of health or a healthy activity” if the product’s sponsor claims the product sustains or generally improves conditions and functions associated with a general state of health, and such claims do not make any reference to diseases or conditions. This first category of general wellness intended uses relates to weight management, physical fitness, relaxation or stress management, mental acuity, self-esteem, sleep management or sexual function. The following are examples of this first category of general wellness claims:
To promote or maintain a healthy weight, encourage healthy eating or assist with weight loss goals
To promote relaxation or manage stress when there is no reference to anxiety disorders or other references to a disease or condition
To promote physical fitness, such as by helping log, track or trend exercise activity; measure aerobic fitness; improve physical fitness; develop or improve endurance, strength or coordination; or improve energy
To address a specific body structure or function, such as increasing or improving muscle size or body tone, toning or firming the body or muscle, enhancing cardiac function, or enhancing or improving sexual performance
To enhance an individual’s participation in recreational activities by monitoring the consequences of participating in such activities, such as by monitoring heart rate or monitoring frequency or impact of collisions
The Draft General Wellness Guidance states that the following claims would not fall within the category of general wellness claims:
To treat or diagnose obesity
To treat an eating disorder, such as anorexia
To treat anxiety
To diagnose or treat autism
To treat muscle atrophy or erectile dysfunction
To restore a structure or function impaired as a result of a disease (e.g., a claim that a prosthetic device enables amputees to play basketball)
A “product associates the role of a healthy lifestyle with helping to reduce the risk or impact of certain chronic diseases or conditions” if it promotes, tracks and/or encourages choices that, as a part of a healthy lifestyle, may help to reduce the risk of, or help people to live well with, certain chronic diseases or conditions. Disease-related claims should only contain references where it is well understood that healthy lifestyle choices may reduce the risk or impact of a chronic disease or medical condition. The following are examples of this second category of general wellness claims:
To promote physical activity, which, as part of a healthy lifestyle, may help reduce the risk of high blood pressure
To track caloric intake and help manage a healthy eating plan, which may help to maintain a healthy weight and balanced diet, and living well with high blood pressure or type 2 diabetes
To track sleep activity patterns and promote healthy sleep habits, which, as part of a healthy lifestyle, may help reduce the risk of developing type 2 diabetes
When does a product present more than a very low risk to user safety?
For purposes of the second criterion, the FDA cautions that the policy decision to not regulate certain general wellness products does not extend to devices that present an inherent risk to user safety. Products intended for a general wellness use that are invasive, involve an intervention or technology that may pose a risk to a user’s safety if regulatory device controls are not applied, raise novel questions or usability, and/or raise questions of biocompatibility would not meet the criteria for non-regulation under the Draft General Wellness Guidance.
The following are examples of products that present inherent risks to a user’s safety and would not be considered low-risk:
Sunlamp products promoted for tanning purposes (because of risks associated with exposure to ultraviolet radiation)
Implants promoted for improved self image or sexual function (because of risk of rupture or adverse reaction to implant materials or implantation procedure)
Lasers that claim to improve confidence in users’ appearance by rejuvenating the skin (because of risk of skin and eye burns, as well as usability considerations that may be addressed with labeling and other design controls)
Decision Algorithm for General Wellness Products
The following flowchart summarizes the process for determining whether a product is a low-risk general wellness product for the purposes of the Draft General Wellness Guidance:
How would a product with a general wellness use be regulated if it falls outside the draft guidance?
A product that falls outside the scope of the Draft General Wellness Guidance (i.e., because it is not deemed low risk) and meets the FD&C Act’s definition of a medical device may be regulated as such by the FDA. The FDA states that the sponsor(s) of products subject to regulation as a medical device must comply with the FDA’s registration and listing, premarket notification, labeling, good manufacturing practice and medical device reporting requirements, among others.
Manufacturers of general wellness products—including mobile medical application developers and other mobile health technologies (e.g., exercise activity trackers, pulse monitors)—will welcome the clear non-regulation position proposed in the Draft General Wellness Guidance, particularly with respect to devices that make well-established claims relating to specific diseases or conditions. The Draft General Wellness Guidance does not address several other health-IT-related topics of interest, however (including devices that incorporate invasive technologies, clinical decision support software built into electronic health record systems, and other health IT), so developers should monitor future health-IT-related FDA guidance.
Draft Accessories Guidance
In the Draft Accessories Guidance, the FDA clarifies when it intends to consider a product an “accessory” and how its risk-based classification framework applies to accessories of other medical devices.
What is a medical device “accessory”?
The Draft Accessories Guidance defines an “accessory” as a “device that is intended to support, supplement and/or augment the performance of one or more parent devices.”
A device supports the performance of a parent device by enabling or facilitating that device to perform according to its intended use.
A device supplements the performance of a parent device if it adds a new function or a new way of using the parent device without changing the intended use of the parent device.
A device augments the performance of a parent device by enabling the device to perform its intended use more safely or effectively.
Examples of device accessories include the following:
A mobile application that controls a medical device (e.g., applications that provide the ability to control inflation and deflation of a blood pressure cuff, or to control the delivery of insulin on an insulin pump by submitting control signals) is an accessory.
A pulse oximeter is an accessory when it allows a mobile application intended for use in active patient monitoring to display oxygen saturation statistics but does not alter the application’s intended use (i.e., to record and display multiple physiological parameters).
A rechargeable battery is an accessory when it is intended to operate when paired with an automated external defibrillator.
A tool for the placement of an implantable nerve stimulator is an accessory when it is intended to augment the performance of the stimulator by facilitating its successful placement.
How does the FDA propose to classify medical device accessories?
Classifying an accessory in the same regulatory class as its parent medical device is appropriate when the accessory, when used as intended, meets the FDA’s criteria for placement in that device class. However, the FDA notes that some accessories may have a lower risk profile than their parent device and therefore may warrant being regulated in a lower class and being subject to fewer regulatory controls. Because accessories are intended to be used with and to support, supplement and/or augment one or more parent devices, the FDA proposes to assess the risk of accessories when used as intended with the parent device type.
Under the Draft Accessories Guidance, the FDA does not necessarily impute all of the risks associated with a parent medical device to an accessory; the FDA specifically acknowledges that the risk profile of an accessory may differ substantially from that of the parent device, warranting differences in regulatory classification. In determining the classification of an accessory, the FDA will evaluate the risks imposed by the accessory’s impact on the parent device and any unique risks of the accessory independent of its parent device. Depending on the FDA’s assessment of these risks, the accessory may be subject to different regulatory requirements and controls, such as premarket clearance notification or approval, current good manufacturing practice requirements, labeling and postmarket safety reporting, among other requirements.
The Draft Accessories Guidance encourages manufacturers and other submitters to utilize the de novo classification process to request the risk-based classification of new types of accessories. Under the de novo process, if a submitter demonstrates that general regulatory controls (or general and special regulatory controls) provide a reasonable assurance of safety and effectiveness for an accessory, the FDA will grant the request and classify the accessory in Class I or Class II. The accessory may then be marketed immediately and serve as a predicate device for future Section “510(k)” premarket clearance notifications. If the de novo request is declined, however, the FDA notes that the accessory remains in Class III and may not be marketed until premarket approval is obtained.
The Draft Accessories Guidance is notable in that the FDA indicates its willingness to apply a different level of regulatory scrutiny to certain medical device accessories—including, potentially, mobile applications that support, supplement or augment a parent medical device—than it does to the parent device itself. The draft guidance does not provide any specific examples of how this process might apply to health IT products, however, and puts the onus on manufacturers to file a regulatory de novo petition with the FDA to seek “a risk-based classification of new types of accessories.” Therefore, the extent to which the draft guidance heralds a change in the FDA’s regulatory position remains to be seen.