Wearables for Medical and Wellness Uses: Standards and FDA Guidance Documents

Diverse Markets Converging for Health and Wellness Wearable Devices Used in the Home Use and Clinical Environments

Why are wearables for medical and wellness uses growing in number? I would say the nexus of smart phones linked with wearables; the huge surge in the use of the Internet of Things (IoT); the ease of clinical monitoring; the aging of societies around the world; the portability of these devices; ease of use for the patient, their caregivers and relatives; and the increasing costs of health care.

This article will focus on the U.S. Food and Drug Administration’s guidance documents and the standards applicable to wearable medical and wellness devices. This article only highlights some requirements that may apply to your device under FDA regulations, and does not discuss regulatory requirements in other jurisdictions.

Most of the standards referenced in this article are FDA recognized consensus standards. Using recognized consensus standards is not mandatory, but failing to use them can create a higher burden of proof that your device is safe and effective. Further, although FDA guidance documents are voluntary, failure to rely on them in preparing your regulatory submission may result in additional questions and slow down the regulatory review and approval process.

The FDA’S Perspective on Wearables

Many current wearable devices fall under lower FDA classifications such as Class I or II and are exempt from the 510(k) submission process. The devices in these classes must be compliant with the FDA’s so-called general controls. But the FDA has decided to exercise discretion regarding devices that fall under the scope of the following guidance documents:

• General Wellness: Policy for Low Risk Devices, Final Guidance; and
• Medical Device Data Systems (MDDS), Medical Image Storage Devices, and Medical Image Communications Devices Guidance, Final Guidance.

Additionally, the FDA will exercise enforcement discretion on devices that are not “mobile medical applications” (MMAs) but that fall under the definition of a “mobile app” that meets the definition of a medical device, per Appendix B of the FDA’s Mobile Medical Application (MMA) Final Guidance. The smallest subset are the MMA devices that truly fall under FDA regulations. FDA fully intends to enforce these requirements as they fall under the Food, Drug and Cosmetic (FD&C) Act where medical devices are defined in section 201(h).

A High-Level Look at FDA Regulations

The FDA’s general controls are the basic provisions (authorities) of the May 28, 1976 Medical Device Amendments to the FD&C Act that provide the agency with the means of regulating devices to ensure their safety and effectiveness. The general controls apply to all medical devices and include provisions that relate to: adulteration; misbranding; device registration and listing; premarket notification; banned devices; notification, including repair, replacement, or refund; records and reports; restricted devices; and good manufacturing practices.

Before we jump into details on the three guidance documents referenced above, it is important to note that, if additional FDA guidance documents are applicable to your device, it is likely that compliance to FDA’s general controls will be required. If so, your device would most likely need to meet the medical device requirements of section 201(h) of the FD&C Act that apply specifically to the medical device.

General Wellness: Policy for Low Risk Devices, Final Guidance

According this FDA Guidance document, a “general wellness” product is defined as a device that:

1. Maintains or encourages a general state of health or a healthy activity & does not make any reference to diseases or conditions; or
2. Sustains or offers general improvement to functions associated with a general state of health while referring to diseases or conditions. This second category is split into 2 sub-categories as part of a healthy lifestyle intends to promote, track, &/or encourage choice(s):
   1. that may help to reduce the risk of certain chronic diseases or conditions; and
   2. that may help living well with certain chronic diseases or conditions

Some examples of consumer-oriented general
wellness devices include fitness bands and multi-function watches.

It is important to note that this Guidance document applies only to low risk general wellness devices. To determine if your device meets this criterion, answer the following questions:

1. Is the product invasive?
2. Is the product implanted?
3. Does the product involve an intervention or technology that may pose a risk to the safety of users and other persons if specific regulatory controls are not applied, such as risks from lasers or radiation exposure?

If you answered “yes” to any of the following questions, your device would not be considered low risk and would not be covered by this Guidance.

MDDS, Medical Image Storage Devices, and Medical Image Communications Device, Final Guidance

As mentioned previously, the FDA doesn’t typically enforce the general controls due to low risk for:

1. Medical device data system (MDDS) (21 CFR 880.6310)
2. Medical image storage devices (21CFR 892.2010)
3. Medical image communications devices (21 CFR 892.2020)

An MDDS is defined as a device (either hardware and/or software) that transfers, displays, stores, and converts formats (using preset specifications) of medical device data that doesn’t control or alter the parameters or functions of any interconnected medical device(s). The Guidance illustrates this with examples such as:

• Software that stores historical blood pressure information for later review by a healthcare provider (i.e., electronic storage & retrieval of medical device data);
• Software that converts digital data generated by a pulse oximeter into a digital format that can be printed (i.e., electronic conversion of medical device data from one format to another based on a preset specification).

MDDS’s don’t include devices connected to active patient monitoring devices. To illustrate, the Guidance provides the following examples of an active patient monitoring (i.e., requires a timely response) device:

• A nurse telemetry station that receives and displays information from a bedside hospital monitor in
  an ICU;
• A device that receives and/or displays information, alarms, or alerts from a monitoring device in a home setting and is intended to alert a caregiver to take an immediate clinical action.

In 2011, the FDA reclassified MDDSs from Class III (the highest risk classification) to Class I (the lowest risk classification). Since this action, the FDA has gained additional experience with this technology and has determined “these devices pose a low risk to the public,” hence, the basis for the agency’s decision to exercise enforcement discretion.

The MDDS guidance does not apply to the following types of devices:

1. Products intended for active patient monitoring;
2. Devices that modifies medical data; or
3. Devices that control functions or parameters of any connected medical device.

Mobile Medical Applications, Final Guidance

This Guidance is intended to help mobile device manufacturers and other concerned parties learn more about the FDA regulatory requirements and to understand how the FDA might classify their application (an application is considered a “device” by the FDA).

The FDA Guidance is based on a three-tier pyramid system depicted in Figure 1. Most mobile applications that run on a mobile platform (i.e., smart phone, tablet, portable computers) aren’t medical devices per section 201(h) of the FD&C Act and aren’t regulated by FDA. This is the bottom level and, since many products meet this definition, it takes up the largest portion of the pyramid. The middle level is where a given application may meet the definition of medical device but is considered to pose a low level of risk, thereby allowing the FDA discretion regarding possible enforcement actions. Last, the top and smallest part of the pyramid is reserved for mobile medical applications, and represents the FDA’s principle area of regulatory focus under the FD&C Act.

Whether or not a given application meets the FDA’s definition of a medical device depends on its intended use. If an application’s intended use is to perform a “medical function,” then it is considered a medical application (“device”) regardless of the platform on which operates. A medical function includes the diagnosis of disease or other conditions, or the mitigation, cure, prevention or treatment of disease, or is intended to affect the structure or any function of the human body.

Mobile applications that meet the definition of a medical application fall in either of the top two tiers of the pyramid. Under the Guidance, the FDA will only regulate those applications (“device”) in the top tier and will exercise enforcement discretion over applications that fall in the middle tier.

Mobile medical applications fall under the definition of a medical device under the FD&C Act, Section 201(h). Additionally, the mobile medical application is intended to either:

• Be used as an accessory to a regulated medical device; or
• Transform a mobile platform into a regulated medical device.

Some lower risk mobile applications over which the FDA intends to exercise enforcement discretion include those that:

• Help patients (i.e., users) self-manage their disease or conditions without providing specific treatment or treatment suggestions;
• Provide patients with simple tools to organize and track their health information;
• Provide easy access to information related to patients’ health conditions or treatments;
• Help patients document, show, or communicate potential medical conditions to health care providers;
• Automate simple tasks for health care providers;
• Enable patients or providers to interact with Personal Health Record (PHR) or Electronic Health Record (EHR) systems; or
• Intended to transfer, store, convert format, and display medical device data in its original format from a medical device (as defined by MDDS regulation 880.6310 OUG).

Appendices A-C of the MMA Guidance provide numerous examples of mobile medical applications at all three tiers of the pyramid. Appendix D covers “Examples of Current Regulations” for specific devices that may include a mobile medical device. Appendix E provides a high-level overview of some medical device regulatory requirements, including for MMAs (as MMAs are considered medical devices per the FDA). The major sections discussed in Appendix E include:

• Establishment Registration (registering manufacturing and distribution locations with the FDA) and Medical Device Listing (notifying the FDA which devices are being marketed) on an annual basis
• Investigational Device Exemption (IDE) Requirements – Allows an investigational device (not cleared or approved for the market) to be used in clinical studies to collect safety and effectiveness data required to support a PMA application or a 510(k) regulatory submission to the FDA. Clinical studies are usually needed for devices which present a higher risk and need to be approved by the FDA and an institutional review board (typically a hospital, but could be other organizations) before a clinical study can begin.
• Labeling Requirements – Labelling requirements for medical devices per 21 CFR Part 801 and for in-vitro devices, per 21 CFR Part 809.
• Premarket submission for approval or clearance – This is the 510(k) and PMA regulatory submission processes. MMAs will tend to fall under the 510(k) submission process unless they are classified as exempt from a 510(k).
• Quality System Regulations – Medical device are required to comply with 21 CFR Part 820 which details quality system regulations (QSRs). The FDA’s QSRs are similar to ISO 13485 medical device quality system requirements in that they aim to control processes rather than prescribing how the device is built. Similar to ISO 9001 and ISO 13485, the FDA’s QSRs provides quality control process guidance from the development of the device through all production and post-production (monitoring for complaints, distribution, installation, etc.) activities.
• Medical Device Reporting (MDR, also known as adverse event reporting) – Applicable when a manufacturer or an importer of a medical device receives a complaint(s) or is otherwise made aware that their device may have malfunctioned or caused or contributed to a serious injury or death.
• Correcting Problems – In some cases, the FDA can ask a medical device manufacturer to correct problems with the device or even request to remove the product from the market. More commonly, the manufacturer may voluntarily take action to correct certain, less serious problems.

Appendix F is for FAQs (Frequently Asked Questions). This section covers a range of questions, such as: how to figure out where a mobile application falls within the scope of the Guidance; why the FDA recommends that manufacturers follow the QSRs for those mobile apps that may be devices and could be MMAs but FDA intends to exercise enforcement discretion; is FDA’s QSR similar to software development practices I use already; etc.

Included at the end of the Guidance is Appendix G. It provides a list of additional resources including FDA recognized consensus standards, FDA guidance documents, and additional standards. A sample of the documents listed in Appendix G, with their current status, include:

• ISO 13485:2003, Medical devices — Quality management systems — Requirements for regulatory purposes: This is an outdated version of the standard, which has been replaced by ISO 13485:2016. However, many ISO certificates are still using this reference since the three year transition period to the new standard ends in 2019. ISO 13485 is not an FDA recognized consensus standard since the FDA has its own quality system regulation, mentioned previously in this article.
• ISO 14971:2007, Medical devices – Application of risk management to medical devices: This has also been adopted in the U.S. as ANSI/AAMI/ISO 14971:2007 and reaffirmed in 2010 (identical adoption). Both referenced versions are FDA recognized consensus standards.
• Clause 14 (Programmable Electrical Medical Systems (PEMS)) of IEC 60601-1:2005 (edition 3) or the U.S. National version ANSI/AAMI ES60601- 1:2005 (adoption with national deviations of IEC 60601-1:2005), Medical electrical equipment, Part 1: General requirements for basic safety and essential performance: Both standard references are for medical electrical equipment but the references are out of date as recognized consensus standards. They have been replaced by IEC 60601-1, 3^rd edition + Amendment 1 (U.S. Adoption of ANSI/AAMI ES60601- 1:2005 + A1:2012)
• ANSI/AAMI/IEC TIR80002-1:2009, Medical device software – Part 1: Guidance on the application of ISO 14971 to medical device software: (Identical adoption of IEC/TR 80002-1:2009) In the current list of FDA recognized standards, only the IEC version of this standard is listed.
• Guidance for Industry and FDA Staff – Implementation of Medical Device Establishment Registration and Device Listing Requirements Established by the Food and Drug Administration Amendments Act of 2007: This Guidance has been withdrawn due to changes to regulatory requirements made in 2013. The website says that “the CDRH is currently working on a new medical device establishment registration and device listing draft guidance that, when finalized, will represent the FDA’s current thinking on this topic.”
• Guidance for Industry – Cybersecurity for Networked Medical Devices Containing Off-the-Shelf (OTS) Software

Conclusion

The world of medical and wellness wearable devices continues to grow in terms of the number of devices in use every year. The FDA has recognized this and has dealt with this part of the digital revolution through its issuance of guidance documents to address these areas. In this way, the agency has reduced enforcement activities focused on lower risk medical devices, which may in turn foster the future development and use of wellness wearable devices. The FDA is also reportedly in the process of establishing a new unit under the Center for Devices & Radiological Health (CDRH), focused exclusively on digital health. Such a move will likely lead to the development of additional guidance documents in this area.

Medical device wearables are also increasing in usage as they can communicate vital information to clinicians via advanced communications technologies; because they can help keep patients out of the hospital and reduce re-admissions; and because they can help manage healthcare costs by reducing the amount of time that patients and clinicians need to be in the same place. 

The advent of wearable devices and other technological changes and their impact on regulations and standards means that manufacturers must stay current on the changing compliance landscape, as well as new standards and regulations now under development.

Leonard (Leo) Eisner is principal medical device product safety and regulatory consultant at Eisner Safety Consultants, which specializes in helping medical device manufacturers through product safety, international regulatory and quality system processes. Eisner’s focus is on active medical electrical equipment including home use and wearable devices. Eisner is the US co-chair of IEC SC62D (majority of IEC 60601-2-xx standards), convener of IEC SC62D JWG9 (IEC/ISO80601-2-58) and a committee member of US TAG for TC62, SC62A, SC62D, & SyC AAL (Active Assisted Living System Committee – Home use medical and non-medical devices). He is also a registered professional engineer in safety and has over 30 years experience in product safety. Eisner is a member of RAPS, AAMI, ASQ, and the IEEE and the manager of the LinkedIn discussion group IEC 60601 Series – Medical Electrical Equipment. He can be reached at Leo@EisnerSafety.com.