Welcome to the sDHT Adoption Library, featuring NaVi
NaVi is a closed-environment AI research assistant that leverages a carefully curated library of more than 300+ vetted documents, including FDA guidance and industry best practices. NaVi helps you search and explore content across the sDHT Adoption Library and Roadmap using natural language questions.
The Library is intended to serve as a living resource. Content is added periodically as new guidance, standards, and peer-reviewed research are released.
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Library scope and selection
To ensure high-quality, relevant results, the Library follows a predefined scoping approach:
- Inclusions: FDA guidance, non-commercial standards, and peer-reviewed research (2018–Present) focused on sDHTs being used as measurement tools for medical products in U.S.-based clinical trials.
- Exclusions: Materials from single commercial entities, non-U.S. regulatory bodies (except select EMA guidances with direct U.S. cross-relevance), and conference proceedings, and conference proceedings.
Inclusion in the Library does not imply endorsement, completeness, or regulatory acceptability.
Library Resources
Library scope
Resources in the sDHT Adoption Library are identified using a predefined scoping approach and include publicly available FDA guidance, non-commercial standards and guidance, and peer-reviewed research relevant to sDHT use in U.S.-based clinical trials. Materials from single commercial entities, non-U.S. regulatory bodies, conference proceedings, and studies conducted exclusively outside the United States are excluded; inclusion does not imply endorsement or regulatory acceptability.
Last updated 2026: Library content is reviewed and updated on a periodic basis as new eligible materials become available.
Showing 3 of 3 results
Collaborative Communities: Addressing Health Care Challenges Together
This FDA webpage discusses Collaborative Communities, which are continuing forums where public and private sector members proactively work together on medical device challenges to achieve common objectives and outcomes. These communities are convened by external stakeholders, not the FDA, and may exist indefinitely, tackling challenges with broad impacts across the healthcare ecosystem. The CDRH participates as a member in several of these communities to contribute its knowledge and perspective on public health challenges and help advance regulatory science and innovation.
Collaborative Communities: Addressing Health Care Challenges Together
2025
FDA
FDA - informational resource
Authors
FDA
This FDA webpage discusses Collaborative Communities, which are continuing forums where public and private sector members proactively work together on medical device challenges to achieve common objectives and outcomes. These communities are convened by external stakeholders, not the FDA, and may exist indefinitely, tackling challenges with broad impacts across the healthcare ecosystem. The CDRH participates as a member in several of these communities to contribute its knowledge and perspective on public health challenges and help advance regulatory science and innovation.
Findings
Collaborative Communities are sustained, multi-stakeholder forums (including patients, industry, academia, and the FDA) dedicated to solving shared challenges in the medical device ecosystem. These communities are not intended to replace formal regulatory mechanisms. They are equipped to perform activities such as:
Developing best practices and strategies.
Generating and evaluating evidence to support novel approaches.
Clarifying ill-defined challenges and generating consensus on definitions.
Addressing issues related to product quality and safety.
Recommendations
The FDA/CDRH does not establish or fund these communities. Instead, the FDA recommends that interested stakeholders convene and lead these groups. The FDA reviews opportunities on a case-by-case basis for participation, considering:
The community's potential public health impact.
Alignment with the CDRH mission, priorities, and resources.
The existence of a formal governance structure, a convener, a plan to measure success, and a mechanism for sustained engagement.
Regulatory Considerations
The FDA's participation in these communities is a strategic priority for advancing regulatory science and fostering responsible medical device innovation. Examples of digital health-related collaborations include those focused on AI/ML, Digital Biomarkers, Digital Health Technologies (DHTs), and Real-World Data (RWD). The outcomes developed by these groups can inform and accelerate the development of science-based solutions to policy and scientific challenges.
Collaborative Communities are sustained, multi-stakeholder forums (including patients, industry, academia, and the FDA) dedicated to solving shared challenges in the medical device ecosystem. These communities are not intended to replace formal regulatory mechanisms. They are equipped to perform activities such as:
Developing best practices and strategies.
Generating and evaluating evidence to support novel approaches.
Clarifying ill-defined challenges and generating consensus on definitions.
Addressing issues related to product quality and safety.
Recommendations
The FDA/CDRH does not establish or fund these communities. Instead, the FDA recommends that interested stakeholders convene and lead these groups. The FDA reviews opportunities on a case-by-case basis for participation, considering:
The community's potential public health impact.
Alignment with the CDRH mission, priorities, and resources.
The existence of a formal governance structure, a convener, a plan to measure success, and a mechanism for sustained engagement.
Regulatory Considerations
The FDA's participation in these communities is a strategic priority for advancing regulatory science and fostering responsible medical device innovation. Examples of digital health-related collaborations include those focused on AI/ML, Digital Biomarkers, Digital Health Technologies (DHTs), and Real-World Data (RWD). The outcomes developed by these groups can inform and accelerate the development of science-based solutions to policy and scientific challenges.
Keywords
& inclusion (DEI)
Artificial intelligence (AI) / Machine learning (ML)
Best practices
Cybersecurity
Digital biomarkers
Digital health policy
Digital health technologies (DHTs)
Diversity
equity
FDA
Healthcare ecosystem
International regulatory harmonization
Medical device development
Medical device development tools (MDDTs)
Patient-centered outcomes
Real-world data (RWD)
Stakeholder collaboration
Technologies
Open Resource
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.
Integration of technology-based outcome measures in clinical trials of Parkinson and other neurodegenerative diseases
An overview of the current and future use of technology-based outcome measures (TOMs) in clinical trials for neurodegenerative disorders, including a systematic review of published and ongoing trials using TOMs, as well as a survey of pharmaceutical companies on their plans to integrate TOMs in future trials.
Integration of technology-based outcome measures in clinical trials of Parkinson and other neurodegenerative diseases
2018
Parkinsonism Relat Disord
Recommendations / best practices
,
Review
Authors
Carlo Alberto Artusi, Murli Mishra, Patricia Latimer, Joaquin A Vizcarra, Leonardo Lopiano, Walter Maetzler, Aristide Merola, Alberto J Espay
An overview of the current and future use of technology-based outcome measures (TOMs) in clinical trials for neurodegenerative disorders, including a systematic review of published and ongoing trials using TOMs, as well as a survey of pharmaceutical companies on their plans to integrate TOMs in future trials.
Findings
TOMs are underutilized in clinical trials for neurodegenerative disorders.
Challenges include relevance of measured targets, standardization of parameters, costs, and patient compliance.
Lack of validation studies for TOMs' clinical meaningfulness and issues with proprietary platform integration.
Recommendations
Validate TOMs output to ensure clinical meaningfulness.
Standardize clinically relevant measures and procedures.
Establish a single platform for data integration from various proprietary platforms.
Assist in regulatory approvals to facilitate wider use of TOMs.
Enhance the ecological validity of TOMs by using them in natural settings.
Regulatory Considerations
Overcome regulatory roadblocks for wider use of TOMs.
Assist manufacturers in obtaining regulatory approvals for TOMs.
Address integration issues with proprietary platforms from different manufacturers.
TOMs are underutilized in clinical trials for neurodegenerative disorders.
Challenges include relevance of measured targets, standardization of parameters, costs, and patient compliance.
Lack of validation studies for TOMs' clinical meaningfulness and issues with proprietary platform integration.
Recommendations
Validate TOMs output to ensure clinical meaningfulness.
Standardize clinically relevant measures and procedures.
Establish a single platform for data integration from various proprietary platforms.
Assist in regulatory approvals to facilitate wider use of TOMs.
Enhance the ecological validity of TOMs by using them in natural settings.
Regulatory Considerations
Overcome regulatory roadblocks for wider use of TOMs.
Assist manufacturers in obtaining regulatory approvals for TOMs.
Address integration issues with proprietary platforms from different manufacturers.
Keywords
Technologies
Open Resource
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.
Modifications to Devices Subject to Premarket Approval (PMA) – The PMA Supplement Decision-Making Process
This guidance helps PMA holders decide which type of regulatory submission is needed for modifications to an approved device, such as traditional PMA, panel-track supplements, 180-day supplements, real-time supplements, Special PMA Supplements, 30-day notices, or manufacturing site change supplements. The document outlines criteria for determining submission types, examples of modifications, and the necessary testing to demonstrate continued safety and effectiveness. The guidance also provides recommendations for annual reports for minor changes.
Modifications to Devices Subject to Premarket Approval (PMA) – The PMA Supplement Decision-Making Process
2008
FDA
FDA guidance - final
Authors
Center for Biologics Evaluation and Research, Center for Devices and Radiological Health
This guidance helps PMA holders decide which type of regulatory submission is needed for modifications to an approved device, such as traditional PMA, panel-track supplements, 180-day supplements, real-time supplements, Special PMA Supplements, 30-day notices, or manufacturing site change supplements. The document outlines criteria for determining submission types, examples of modifications, and the necessary testing to demonstrate continued safety and effectiveness. The guidance also provides recommendations for annual reports for minor changes.
Findings
Changes affecting the safety or effectiveness of a device typically require PMA supplements, categorized based on the nature of the change and required data.
Substantial changes (e.g., new indications or significant design modifications) may require a panel-track supplement or traditional PMA.
Minor modifications (e.g., certain design changes or labeling updates) can often be addressed with 180-day or real-time supplements.
Manufacturing changes impacting safety or effectiveness may be submitted as a 30-day notice or manufacturing site change supplement.
Risk analysis and assessment are critical in determining the appropriate regulatory pathway.
Recommendations
Conduct a thorough risk analysis for all modifications to assess potential impacts on safety and effectiveness.
For substantial design or performance changes, submit a panel-track supplement or traditional PMA, supported by substantial clinical data.
Use 180-day supplements for significant but less extensive changes, supported primarily by preclinical data or limited clinical testing.
Minor changes, such as software updates or sterilization changes, may qualify for real-time supplements if they can be evaluated within a single scientific discipline.
Submit minor manufacturing changes via 30-day notices or annual reports, ensuring all supporting documentation is complete.
Regulatory Considerations
Major modifications requiring new clinical data typically fall under panel-track supplements or traditional PMAs.
Manufacturing changes affecting safety and effectiveness must comply with 21 CFR 814.39 and can be submitted via 30-day notices or 180-day supplements.
Real-time supplements are limited to minor changes and require FDA pre-approval for expedited review.
Annual reports should include minor updates that do not impact device safety or effectiveness, as outlined in the guidance.
Manufacturing site changes are considered 180-day supplements and may involve pre-approval inspections depending on the nature of the change.
Changes affecting the safety or effectiveness of a device typically require PMA supplements, categorized based on the nature of the change and required data.
Substantial changes (e.g., new indications or significant design modifications) may require a panel-track supplement or traditional PMA.
Minor modifications (e.g., certain design changes or labeling updates) can often be addressed with 180-day or real-time supplements.
Manufacturing changes impacting safety or effectiveness may be submitted as a 30-day notice or manufacturing site change supplement.
Risk analysis and assessment are critical in determining the appropriate regulatory pathway.
Recommendations
Conduct a thorough risk analysis for all modifications to assess potential impacts on safety and effectiveness.
For substantial design or performance changes, submit a panel-track supplement or traditional PMA, supported by substantial clinical data.
Use 180-day supplements for significant but less extensive changes, supported primarily by preclinical data or limited clinical testing.
Minor changes, such as software updates or sterilization changes, may qualify for real-time supplements if they can be evaluated within a single scientific discipline.
Submit minor manufacturing changes via 30-day notices or annual reports, ensuring all supporting documentation is complete.
Regulatory Considerations
Major modifications requiring new clinical data typically fall under panel-track supplements or traditional PMAs.
Manufacturing changes affecting safety and effectiveness must comply with 21 CFR 814.39 and can be submitted via 30-day notices or 180-day supplements.
Real-time supplements are limited to minor changes and require FDA pre-approval for expedited review.
Annual reports should include minor updates that do not impact device safety or effectiveness, as outlined in the guidance.
Manufacturing site changes are considered 180-day supplements and may involve pre-approval inspections depending on the nature of the change.
Keywords
Open Resource
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.