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Embracing Digital Health Technologies: FDA’s New Guidance for Clinical Trials

In December 2023, The U.S. Food and Drug Administration (FDA) issued Industry Guidance on Digital Health Technologies for Remote Data Acquisition in Clinical Investigations. FDA identified digital health technologies (DHTs) as “systems that use computing platforms, connectivity, software, and/or sensors, for health care” and focused on the use of these DHTs to permit remote data acquisition from clinical trial participants.

Compared to intermittent trial visits, the use of DHTs to remotely collect data from trial participants may allow for more frequent or continuous data collection. This may provide a broader picture of how participants feel or function in their daily lives. DHTs provide opportunities to record data from trial participants (e.g., biomarkers, performance of activities of daily living, sleep, vital signs) wherever the participants may be (e.g., home, school, work, outdoors). The data collection may involve passive monitoring by the DHT or the acquisition of data while participants are actively interacting with the DHT. Data captured by DHTs can often be transmitted directly to investigators, sponsors, and/or other authorized parties, with the capability to maintain blinding or masking of the data when appropriate.

DHT examples include:

  • Off-the-shelf consumer activity tracker bracelets with sensors and software to measure step counts
  • Mobile smartphone applications used to complete a clinical outcome assessment (COA) memory task
    • Measuring a memory task
    • Sending participant reminders to complete the memory task
  • Continuous glucose monitoring to track hypoglycemic episodes remotely
    • Measure glucose levels continuously
    • Analyze data to identify hypoglycemic episodes as an endpoint
    • Display data to participants
    • Alert participants of hypoglycemia
  • Multiple DHTs used concurrently as part of a clinical investigation
    • Spirometer with smart connectivity
    • Activity tracker bracelet
    • Mobile smartphone application to rate activity tolerance and daily function

The intended use of DHT in the clinical study may determine the DHT medical device risk classification subject to IDE Regulations. This classification applies even if the DHT is available off-the-shelf. In many cases, a DHT could be considered nonsignificant risk (NSR) or exempt (i.e., marketed product used according to its label indication), and therefore, it would not require an IDE application for use as a data collection medical device.

It is, however, important to note that DHTs, including software applications, that qualify as medical devices are still subject to design control requirements. The FDA requires for a DHT without FDA marketing authorization to have evidence of sufficient design verification, which is objective proof that the DHT accurately measures the specified parameter. Additionally, there must be validation, which ensures the DHT appropriately measures the clinical event or characteristic in question. This evidence is necessary to confirm the DHT as suitable for its intended data collection function. Existing manufacturer information, such as manufacturer product labeling or right of reference to other FDA submissions, can support DHT performance claims. Nonetheless, the sponsor is responsible for ensuring the DHT remains suitable for the purpose of the clinical trial throughout the duration of the study.

Selecting a DHT for a clinical investigation should address certain specifications. These may include:

  1. Clinical Trial Population – education, language, age, technical aptitude, usability
  2. Technical and Performance Specification – distinct product model/version with minimum technical and performance specifications
  3. Design and Operation of DHTs and Other Technologies – material, size, weight, appearance, portability; how participants interact with the DHT and with the data output; power needs (ex., battery life, recharging); data storage capacity, data transmission; alerts (ex., low battery, poor signal, data recording/transmission interruption); environmental factors that affect DHT performance; capacity to manage volumes of data transfer (especially for frequent or continuous monitoring); cybersecurity and privacy and security controls
  4. Use of a Participant’s Own DHT or Other Technology – must still be fit for the purpose of the clinical trial and allow for continuity across participants and data capture

In addition to the above specifications, a description of the DHT, including information about data management procedures and controls (i.e., collection, storage, transmission and archive), is an important part of the regulatory submission in order to demonstrate data integrity.

It’s vital to understand that the FDA considers electronic data that are in the first durable electronic data repository to which the data are transferred to be the source data. These source data must be maintained according to record retention requirements. Human readable data and metadata should be available for inspection.

Usability evaluations should identify and address any potential use errors or difficulties that trial participants or other intended users may experience when using the DHT. Analyses of data collected from DHTs should be discussed in a statistical analysis plan.

Download and read the entire guidance document here.


How Can NAMSA Help?

NAMSA has a wealth of experience collaborating with medical device developers who specialize in a diverse range of products, including patient monitoring, disease management, Picture Archiving and Communication System (PACS) imaging and other software-containing medical devices whose value and effectiveness can be enhanced through Mobile Health (mHealth) technology.

We offer comprehensive regulatory and quality consulting services to organizations involved in the design, production, development, supply or deployment and use of the following:

  • Software as a Medical Device (SaMD)
  • Mobile Medical Apps
  • Medical devices of all types with a particular focus on “active” devices and in vitro diagnostic (IVD) medical devices with or without software components or accessories
  • Clinical Decision Support and health analytical software
  • Software as a Service (SaaS) within the healthcare sector
  • Artificial Intelligence (AI), deep learning, machine learning, big data algorithms

Our support extends to qualification proposals for Center for Devices and Radiological Health’s (CDRH) MDDT (Medical Device Development Tool) Qualification Program independent of an individual DHT marketing submission or a submission for a clinical investigation using the DHT to collect data remotely.

NAMSA’s Global Strategy Team consists of highly skilled, cross-functional scientific and strategic consultants with technical expertise spanning the entire medical device development continuum. This group of industry experts works closely with clients to develop effective market introduction and commercialization strategies for innovative medical device and drug-device technologies. Our approach includes effective interactions with global regulatory agencies that lead to successful development outcomes.

If you are interested in speaking with us about regulatory strategies, please Contact Us, or learn more about our Regulatory Experts at namsa.com/subject-matter-experts.

Wendy Schroeder, RN, BSN, CCRC/PM, CRCP

Wendy Schroeder has been involved with research and clinical trials for more than 20 years, and has a deep understanding of in vitro diagnostics (IVDs) and companion diagnostics (CDx). She has served as a key company stakeholder in the implementation of an in-house contract research organization (CRO) infrastructure for a commercial laboratory moving bench IVD science into clinical validation studies and launching a biorepository of blood samples with annotated clinical data. Wendy has provided research operations oversight for commercial laboratories (Caris Life Sciences, Ashion Analytics) and IVD manufacturers (VisionGate, Inc.) as well as at hospital and clinical sites. Wendy holds a Bachelor of Science in nursing degree from Arizona State University (Tempe, AZ). She is a certified Research Coordinator and Project Manager (ACRP) and a certified Research Contracts Professional (MAGI). She has been an invited speaker and author of peer-reviewed journal publications on molecular diagnostics (MDx), clinical trial billing and IVD/Laboratory Developed Test (LDT) regulatory matters.