Digital health technologies (DHTs) offer many potential benefits in the development of medical products, including drugs. Advances in DHTs, including electronic sensors, computing platforms and information technology, provide new opportunities to obtain clinical trial data directly from patients. Portable DHTs that may be worn, implanted, ingested, or placed in the environment allow real-time collection of data from trial participants in their homes or at locations remote from clinical trial sites. Potential advantages of these DHTs include the ability to:

• make continuous or frequent measurements of clinical features
• record or measure novel clinical features that could not be captured during traditional study visits
• decentralize clinical trial activities by obtaining clinical data from study participants remotely

FDA is committed to supporting the use of DHTs in clinical drug development and has developed a comprehensive program to engage with stakeholders in this important scientific area.

The Prescription Drug User Fee Act VII has outlined several activities related to DHTs for drug development and review, which FDA has committed to undertake. These activities include:

• Publishing a Framework for the Use of Digital Health Technologies (DHTs) in Drug and Biological Product Development
• Establishing a DHT Steering Committee
• Convening Public Meetings
• Identifying Demonstration Projects

Sections 3606 and 3607 of the Food and Drug Omnibus Reform Act of 2022 outline additional requirements for FDA to publish guidance regarding the modernization of clinical trials through decentralized clinical trials and DHTs.

The CDRH Digital Health Center of Excellence, which was established to empower stakeholders to advance health care by fostering responsible and high-quality digital health innovation, can also serve as a resource on DHTs, including their regulatory status, for sponsors, DHT manufacturers, and other stakeholders.

Framework for the Use of DHTs in Drug and Biological Product Development

As part of our PDUFA VII commitment, FDA developed a framework, titled Framework for the Use of DHTs in Drug and Biological Product Development.

The program will include workshops and demonstration projects; engagement with stakeholders; establishment of internal processes to support the evaluation of DHTs for use in drug development; promotion of shared learning and consistency regarding DHT-based policy, procedure, and analytic tool development; and publication of guidance documents.

DHT Steering Committee

As part of our PDUFA VII commitments, FDA has established the DHT Steering Committee which consists of senior staff from CDER, CBER, and CDRH, including the Digital Health Center of Excellence, as well as the Oncology Center of Excellence and the Office of Clinical Policy and Programs. The Steering Committee will support the implementation of the framework for the use of DHTs in drug and biological product development as well as other commitments identified in the section “Enhancing Use of Digital Health Technologies to Support Drug Development and Review” of the PDUFA VII commitment letter (e.g., public meetings, guidance documents, demonstration projects, technology needs, training). In addition, the Steering Committee will oversee activities to assist organizational units with consistent approaches to the review of drug submissions that contain DHT-derived data. Further, the Steering Committee will engage with external stakeholders on DHT-related issues in human drug development and gather information about the present state of DHTs, including specific challenges in their use.

Meeting with FDA

FDA encourages stakeholders who are considering the use of DHTs in drug development or conducting a decentralized clinical trials (DCTs) to reach out to the agency early.

Click on Meeting with FDA to learn more about when and how to engage FDA.

Public Meetings/ Workshops

Meeting our PDUFA VII Commitment

By the end of the 2nd quarter of fiscal year 2023, FDA will convene the first of a series of five public meetings or workshops with key stakeholders, including patients, biopharmaceutical companies, DHT developers, and academia, to gather input on issues related to the use of DHTs in regulatory decision-making related to drug and biological product development.

• March 28-29, 2023: Understanding Priorities for the Development of Digital Health Technologies to Support Clinical Trials for Drug Development and Review

Other Public Webinars

• June 20, 2023: SBIA Webinar: Decentralized Clinical Trials (DCT) Draft Guidance
• Feb 10, 2022: SBIA Webinar: Digital Health Technologies for Remote Data Acquisition Draft Guidance

Related Guidances

• Digital Health Technologies for Remote Acquisition in Clinical Investigations
• Decentralized Clinical Trials for Drugs, Biological Products, and Devices
• Framework for the Use of DHTs in Drug and Biological Product Development
• Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations: Questions and Answers
• Guidances with Digital Health Content

Resources

• CDER Conversation: The Evolving Role of Decentralized Clinical Trials and Digital Health Technologies
• PDUFA VII IT and Bioinformatics Goals and Progress
• CDRH Digital Health Center of Excellence
• FDA Digital Health Regulatory Policies
• CDER's Drug Development Tools (DDT) Qualification Programs
• Innovative Science and Technology Approaches for New Drugs (ISTAND) Pilot Program
• CDRH’s Medical Device Development Tools (MDDT) Qualification Programs

Contact Information

For more information about DHTs for Drug Development, please email DHTsforDrugDevelopment@fda.hhs.gov.

For information about devices and to engage the Digital Health Center of Excellence, send an email to digitalhealth@fda.hhs.gov