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. 11–12, 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)
“When justifying a novel endpoint using data captured by the DHT, sponsors should address the following:
- Whether the endpoint reflects how a participant feels, functions, or survives.
- Whether a biomarker serving as a surrogate endpoint will predict or will be reasonably likely to predict clinical benefit.
- Whether the effect of the intervention as captured by the novel endpoint is meaningful to the target patient population for the medical product being evaluated.
- How the endpoint relates to other endpoints that are intended to reflect the same concept and have been used to support a marketing authorization for a similar indication. In the absence of related endpoints, evidence from other sources of information (e.g., literature or input from stakeholders and experts) may support use of the endpoint.
- Whether the novel endpoint is a well-defined and reliable measure of disease severity or health status (e.g., mild, moderate, or severe) to allow assessment of disease modification or progression.
- When an existing medical product has already received marketing authorization based on evidence from a study using an established endpoint for the disease or condition of interest and the concept being evaluated by the novel endpoint is similar, it may be useful to determine whether the effect of that existing medical product (positive control) can be detected using the novel endpoint.”
– Section IV.D (Evaluation of Endpoints Involving Data Collected Using DHTs), p. 16–17, Digital Health Technologies for Remote Data Acquisition in Clinical Investigations, Final, 2023 (FDA)
Q-Submission Program
Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program
Pre-Submissions (Pre-Subs) allow submitters to obtain FDA feedback on specific questions before submitting formal IDEs, 510(k)s, PMAs, or other applications. Early feedback can improve submission quality and streamline the review process.
Submission Issue Requests (SIRs) provide a mechanism for addressing issues raised in FDA hold letters (e.g., 510(k) deficiencies) to help expedite resolutions.
Study Risk Determinations help sponsors clarify whether clinical studies are significant risk (SR), non-significant risk (NSR), or exempt from IDE regulations.
Informational Meetings are non-feedback sessions aimed at familiarizing FDA staff with new devices or sharing updates on ongoing development.
The program encourages timely submissions, including supplements for ongoing discussions and amendments to update materials.
Recommendations
Clearly define the purpose and goals of the Q-Sub in the submission to facilitate effective FDA review.
Include specific, well-formulated questions that focus on a limited number of topics to ensure actionable feedback.
For Pre-Subs, align planned testing and submissions with FDA guidance and include detailed device descriptions, testing protocols, and relevant background information.
Use SIRs to discuss proposed solutions to deficiencies raised in FDA hold letters, focusing on timely resolution.
Draft and submit meeting minutes promptly (within 15 days of meetings) to ensure accurate documentation of FDA feedback.
Regulatory Considerations
Submitters should adhere to the timelines specified for different Q-Sub types, including 70 days for Pre-Sub feedback or 21 days for SIRs submitted promptly after a hold letter.
Q-Subs should include all relevant regulatory history and references to prior FDA communications to streamline the review process.
FDA feedback through the Q-Sub program is non-binding and based on the information available at the time; subsequent submissions must align with the provided feedback to maintain consistency.
Informational Meeting requests should clearly state that feedback is not expected and may be used to track interactions outside other formal Q-Sub types.
Confidentiality of Q-Subs is maintained in compliance with FDA’s disclosure regulations and the Freedom of Information Act (FOIA).
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.
Non-clinical Bench Performance Testing Questions
“We have provided a justification of the worst-case testing volume that will be used, and provided an analysis of the sensitivity of the test, as requested. Does FDA find this justification and analysis adequate to support using the methodology described in our testing protocol? If not, please provide further guidance.”
“Is the approach to use the average of valid measurements of the five replicate measurements acceptable/appropriate?”
– Appendix 2 (Example Pre-Sub Questions), p. 34, Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program, Final, May 29, 2025 (FDA)
Once you’ve read the guidances, explore these best practices from the field:
Industry spotlight
Gathers real-world examples, case studies, best practices, and lessons learned from peers and leaders in the field relevant to this section. Use these insights to accelerate your work and avoid common pitfalls.