Regulatory spotlight
We offer selected excerpts from relevant guidances below, to help you get oriented and understand their significance. It is your responsibility to fully examine and interrogate these guidances in detail. Click through on individual resource links to be taken to the primary source material.
Remote data acquisition
Digital Health Technologies for Remote Data Acquisition in Clinical Investigations
There is a need for comprehensive validation and verification processes for DHTs.
Ensuring data security and privacy is a significant concern.
Usability issues for diverse populations need to be addressed.
There is a lack of clarity on whether certain DHTs meet the definition of a device under the FD&C Act.
The guidance does not establish legally enforceable responsibilities.
Recommendations
Ensure DHTs are fit-for-purpose for clinical investigations.
Implement robust data security measures to protect participant information.
Conduct usability evaluations to ensure DHTs can be used by intended populations.
Engage with FDA early to discuss the use of DHTs in clinical investigations.
Develop a risk management plan to address potential issues with DHT use.
Regulatory Considerations
Verification and validation should be addressed regardless of device classification.
Sponsors should ensure compliance with data protection and privacy regulations.
FDA evaluates DHT data based on endpoints, medical products, and patient populations. Sponsors can engage with FDA’s Q-Submission Program for feedback on DHT usage in clinical trials.
Sponsors should understand the legal implications of using DHTs in clinical investigations.
The guidance provides recommendations but does not establish legally enforceable responsibilities.
Some summaries are generated with the help of a large language model; always view the linked primary source of a resource you are interested in.
“This guidance uses the terms verification and validation to describe steps that help ensure that the DHT is fit-for-purpose for remote data collection in a clinical investigation. Verification and validation should be addressed regardless of whether the DHT meets the definition of a device under section 201(h) of the FD&C Act. For the purposes of this guidance, verification is confirmation by examination and provision of objective evidence that the parameter that the DHT measures (e.g., acceleration, temperature, pressure) is measured accurately and precisely. Validation is confirmation by examination and provision of objective evidence that the selected DHT appropriately assesses the clinical event or characteristic in the proposed participant population (e.g., step count or heart rate). Verification is often viewed as part of the validation process since validation is highly dependent upon comprehensive testing and other verification tasks previously completed at each stage of the development life cycle. Verification and validation activities should consider all relevant functions of the DHT in the context of use in the clinical investigation.”
– Section IV.C (Verification, Validation, and Usability Evaluations of Digital Health Technologies), p. 11, Digital Health Technologies for Remote Data Acquisition in Clinical Investigations, Final, 2023 (FDA)
“Verification confirms that the DHT meets its expected performance specifications. Verification can include conforming to consensus performance standards, when applicable (e.g., International Electrotechnical Commission 60601-1) and/or an analysis to identify potential failure modes of a DHT and their causes and effects (e.g., failure modes and effects analysis). For some DHTs and clinical investigations, it may be appropriate to identify and specify the conditions (e.g., temperature range) under which the DHT meets performance specifications.”
– Section IV.C.1 (Further Considerations for Verifying and Validating DHTs), p. 12, Digital Health Technologies for Remote Data Acquisition in Clinical Investigations, Final, 2023 (FDA)
“As discussed previously, sponsors can leverage verification and validation data made available (1) by DHT manufacturers or other third parties publicly, (2) in device labeling, or (3) by right of reference to other FDA submissions, when appropriate.”
– Section IV.C (Verification, Validation, and Usability Evaluations of Digital Health Technologies), p. 12–13, Digital Health Technologies for Remote Data Acquisition in Clinical Investigations, Final, 2023 (FDA)
Once you’ve read the guidances, explore these best practices from the field:
Industry spotlight
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