Producers of telethermographic systems and digital health devices cleared for the treatment of behavioral and psychiatric disorders will be temporarily exempted from most regulatory requirements by the FDA. The move is intended to help support healthcare workers and patients during the COVID-19 emergency.
By Laura DiAngelo, MPH
How Things Work Now
Medical devices are typically subject to regulatory review by the FDA before gaining market access, unless otherwise exempted. This applies both in cases where a device is new to market and when a manufacturer makes “significant” updates to an existing device. Significant changes may include the use of a new material, an update to the product’s intended use, a change to its manufacturing process, or a new digital or wireless capability.
In these circumstances, the manufacturer is required to submit a supplement to the FDA for its review or clearance. This policy is intended to ensure that any changes to the device do not alter the product’s function beyond the scope of its original approval or clearance, and that no patients are potentially harmed by the changes.
Over the past week, the FDA has issued two new policies to help expand access to medical devices in response to the COVID-19 pandemic: telethermographic systems and digital tools used for behavioral health monitoring.
Telethermographic systems are products that can measure temperature by detecting infrared radiation and translating that information for use by a provider. For example, they may take the form of a hand-held infrared camera. Telethermographic systems are regulated as Class II, moderate-risk medical devices when they are used for medical purposes, and the sponsor is required to submit a 510(k) application.
Under the FDA’s new guidance manufacturers of telethermographic systems may update the intended use of their devices to indicate their usage in determining “initial body temperature measurement for triage use” without submitting a new 510(k).
However, the expanded indication will only apply to triage use specifically, and temperature measurement should be confirmed with a secondary method, such as a thermometer. The guidance is immediately in effect, and will remain so until the conclusion of the declared public health emergency,
Currently, there are 37 510(k)s listed for telethermographic systems. However, the FDA as recently as 2019 issued Safety Communications regarding their accuracy, stating that “there is no valid scientific data to demonstrate that thermography devices, when used on their own or with another diagnostic test, are an effective screening tool for any medical condition.” This new policy comes after the FDA last week issued policies allowing entities to make and distribute thermometers without submitting applications to the FDA, indicating that there is still widespread need for temperature measuring tools. Additionally, telethermographic systems can be used without touching a patient, which can help ensure the safety of a provider.
Digital Devices for Behavioral Health Conditions
Computerized behavioral therapy devices for psychiatric disorders are intended as computerized versions of condition-specific behavioral health to facilitate clinician treatment. These tools can provide a system that supplements standard therapies (including talk therapy) to improve treatment outcomes. The y are regulated as Class II devices (product code PWE), which means that they are typically subject to 510(k) requirements for both products new to market and substantial changes to an already-marketed product.
The FDA recently issued guidance exempting some functions of these devices from the definition of a “medical device,” instead defining them as a “general wellness” product and will further exercise enforcement discretion on regulatory requirements for medical device functions. The exemption applies to both prescription-use-only computerized behavioral health therapeutic devices and those for psychiatric disorders (which do not fit within the scope of product code PWE), including software as a medical device and other digital solutions.
In general, the FDA states that it will consider certain functions of these types of devices as “general wellness” products during the time of the public health emergency. It will neither review products to determine if they meet the regulatory definition of a medical device (e.g., software such as meditation apps or nutritional guides are not considered medical devices) nor enforce the applicable regulatory requirements, in line with its guidance on the regulation of general wellness products.
The functions of these devices that will be considered “general wellness,” and therefore not subject to regulation as a medical device, will include non-treatment related functions such as relaxation and mindfulness promotion, stress or isolation reduction exercises, improved sleep functions, and software functions related to reducing COVID-19-related stress specifically. Additionally, the FDA will allow for some new software functions, including those that provide reminders to practice social distancing practices during the emergency.
Additionally, the FDA will waive certain requirements for functions of these device-types that are considered to be medical devices. These include software functions that track or encourage healthy lifestyles for chronic psychiatric conditions, functional behavioral skill techniques through the software, or functions that can help users self-manage a condition (e.g., tracking the signs and symptoms of their disorder).
Device functions that treat the condition, however, would still be subject to regulatory requirements.
The FDA will waive several regulatory requirements for these products during the public health emergency, including 510(k) notification requirements, several reporting requirements (e.g., Correction and Removals, Registration and Listing) and Unique Device Identification (UDI) requirements. Additionally, for psychiatric devices, the FDA will not enforce the special controls typically required, including the collection of prospective clinical data.
These actions align with the FDA’s recent spate of guidances intended to both increase availability of tools in shortage by expanding allowable uses of alternative devices and reducing health care provider risk by allowing new remote and distanced uses. A provider using a telethermographic device, for example, can stay farther away from a potential COVID-19 patient than would be possible with a regular clinical thermometer, and increased capabilities for behavioral and psychiatric digital tools reduce the need for face-to-face contact with a mental health provider.
By exempting additional functions of software products for behavioral health and psychiatric health from the definition of a medical device, this could help expand the functionality of those products already in use. However, if those functions must be removed (or submitted under a 510(k)) following the conclusion of the emergency, software developers may be unlikely to invest in and implement them.
The guidance documents are in effect for the duration of the public health emergency.