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.
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510(k) Premarket Notification
This website provides public access to the FDA's Premarket Notification 510(k) database. It serves as a comprehensive repository of medical devices that have been cleared for marketing in the United States. The database allows users to search for specific devices, manufacturers, or 510(k) numbers to verify regulatory clearance and review summary documents. The core function of this resource is to provide transparency into the 510(k) process, which requires manufacturers to demonstrate that a new device is substantially equivalent in safety and effectiveness to a legally marketed predicate device. It is a critical tool for regulatory professionals, competitors, and researchers.
510(k) Premarket Notification
2025
FDA
Database
Authors
FDA
This website provides public access to the FDA's Premarket Notification 510(k) database. It serves as a comprehensive repository of medical devices that have been cleared for marketing in the United States. The database allows users to search for specific devices, manufacturers, or 510(k) numbers to verify regulatory clearance and review summary documents. The core function of this resource is to provide transparency into the 510(k) process, which requires manufacturers to demonstrate that a new device is substantially equivalent in safety and effectiveness to a legally marketed predicate device. It is a critical tool for regulatory professionals, competitors, and researchers.
Regulatory Considerations
The Premarket Notification (510(k)) database is a critical component of the FDA's regulatory framework for medical devices. Its primary function is to house information on devices that have been cleared through the 510(k) pathway, which is the most common route to market for medical devices in the U.S.
A 510(k) submission's central requirement is to demonstrate "substantial equivalence" to a legally marketed predicate device. This means the new device is as safe and effective as a device already on the market. Clearance of a 510(k) does not denote "approval" in the same way as a Premarket Approval (PMA) application but rather confirms that the device meets the necessary criteria for marketing.
The database provides transparency and serves as an essential resource for manufacturers to identify potential predicate devices for their own submissions. For healthcare providers, patients, and researchers, it offers a way to verify the regulatory status and clearance basis for a specific device.
The Premarket Notification (510(k)) database is a critical component of the FDA's regulatory framework for medical devices. Its primary function is to house information on devices that have been cleared through the 510(k) pathway, which is the most common route to market for medical devices in the U.S.
A 510(k) submission's central requirement is to demonstrate "substantial equivalence" to a legally marketed predicate device. This means the new device is as safe and effective as a device already on the market. Clearance of a 510(k) does not denote "approval" in the same way as a Premarket Approval (PMA) application but rather confirms that the device meets the necessary criteria for marketing.
The database provides transparency and serves as an essential resource for manufacturers to identify potential predicate devices for their own submissions. For healthcare providers, patients, and researchers, it offers a way to verify the regulatory status and clearance basis for a specific device.
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.
Deciding When to Submit a 510(k) for a Software Change to an Existing Device
This guidance assists manufacturers in determining whether software changes to an existing 510(k)-cleared medical device require a new submission. It outlines a decision-making framework based on the potential impact of the change on the safety and effectiveness of the device. A flowchart and guiding principles help manufacturers assess changes, such as cybersecurity updates, performance improvements, or risk control modifications. The document emphasizes a risk-based assessment process and compliance with FDA's Quality System (QS) regulation.
Deciding When to Submit a 510(k) for a Software Change to an Existing Device
2017
FDA
FDA guidance - final
Authors
FDA
This guidance assists manufacturers in determining whether software changes to an existing 510(k)-cleared medical device require a new submission. It outlines a decision-making framework based on the potential impact of the change on the safety and effectiveness of the device. A flowchart and guiding principles help manufacturers assess changes, such as cybersecurity updates, performance improvements, or risk control modifications. The document emphasizes a risk-based assessment process and compliance with FDA's Quality System (QS) regulation.
Findings
Software changes must be assessed for potential impacts on the safety and effectiveness of the device, even if they are routine updates.
A risk-based assessment is required to determine whether changes introduce new risks, modify existing risks, or necessitate new risk controls.
Cybersecurity updates, routine maintenance changes, and minor clarifications may not require a new 510(k) if they do not affect performance specifications or safety.
Substantial modifications, such as adding new algorithms, introducing new functionalities, or modifying clinical performance, generally require a new 510(k).
Manufacturers must document all changes, even those not requiring a new 510(k), in compliance with QS regulations.
Recommendations
Use the provided flowchart and guiding principles to evaluate whether software changes exceed the regulatory threshold for submission of a new 510(k).
Conduct a risk-based assessment for all changes, focusing on new or modified risks and the adequacy of existing risk controls.
Verify and validate changes to ensure they meet device specifications and do not introduce unintended consequences.
Submit a new 510(k) for changes that significantly affect clinical functionality, performance specifications, or introduce new risks that are not mitigated.
Maintain detailed documentation of all decisions regarding software changes, including rationale for whether submission of a new 510(k) was required.
Regulatory Considerations
Submission of a new 510(k) is required for changes that could significantly impact the safety or effectiveness of a device or constitute a major modification to its intended use.
Cybersecurity updates generally do not require a new 510(k) if they solely strengthen security without affecting device performance.
Manufacturers must evaluate cumulative changes and submit a new 510(k) if the combined impact exceeds the regulatory threshold.
Device software changes involving substantial algorithm modifications or system architecture updates are likely to require a new 510(k).
Changes that address compliance during a recall or correction must be evaluated under FDA's guidance for recalls and device enhancements.
Software changes must be assessed for potential impacts on the safety and effectiveness of the device, even if they are routine updates.
A risk-based assessment is required to determine whether changes introduce new risks, modify existing risks, or necessitate new risk controls.
Cybersecurity updates, routine maintenance changes, and minor clarifications may not require a new 510(k) if they do not affect performance specifications or safety.
Substantial modifications, such as adding new algorithms, introducing new functionalities, or modifying clinical performance, generally require a new 510(k).
Manufacturers must document all changes, even those not requiring a new 510(k), in compliance with QS regulations.
Recommendations
Use the provided flowchart and guiding principles to evaluate whether software changes exceed the regulatory threshold for submission of a new 510(k).
Conduct a risk-based assessment for all changes, focusing on new or modified risks and the adequacy of existing risk controls.
Verify and validate changes to ensure they meet device specifications and do not introduce unintended consequences.
Submit a new 510(k) for changes that significantly affect clinical functionality, performance specifications, or introduce new risks that are not mitigated.
Maintain detailed documentation of all decisions regarding software changes, including rationale for whether submission of a new 510(k) was required.
Regulatory Considerations
Submission of a new 510(k) is required for changes that could significantly impact the safety or effectiveness of a device or constitute a major modification to its intended use.
Cybersecurity updates generally do not require a new 510(k) if they solely strengthen security without affecting device performance.
Manufacturers must evaluate cumulative changes and submit a new 510(k) if the combined impact exceeds the regulatory threshold.
Device software changes involving substantial algorithm modifications or system architecture updates are likely to require a new 510(k).
Changes that address compliance during a recall or correction must be evaluated under FDA's guidance for recalls and device enhancements.
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.
Medical Device Accessories – Describing Accessories and Classification Pathways
This guidance describes FDA’s policy for classifying medical device accessories based on their risks when used with parent devices. It outlines two main questions for accessory classification: whether the article qualifies as an accessory and what risks it presents. The document also provides pathways for classifying new or existing accessory types through Accessory Requests and the De Novo classification process. It emphasizes that accessories should not automatically share the classification of their parent devices but be evaluated independently for appropriate regulatory controls.
Medical Device Accessories – Describing Accessories and Classification Pathways
2017
FDA
FDA guidance - final
Authors
Center for Biologics Evaluation and Research
This guidance describes FDA’s policy for classifying medical device accessories based on their risks when used with parent devices. It outlines two main questions for accessory classification: whether the article qualifies as an accessory and what risks it presents. The document also provides pathways for classifying new or existing accessory types through Accessory Requests and the De Novo classification process. It emphasizes that accessories should not automatically share the classification of their parent devices but be evaluated independently for appropriate regulatory controls.
Findings
An accessory is defined as a finished device that supports, supplements, or augments the performance of a parent device.
Accessories are classified based on their individual risk profiles when used with parent devices, which may differ from the classification of the parent device.
The De Novo process can be used for new accessory types with no existing classification, enabling lower-risk accessories to be classified in Class I or II.
Articles not specifically intended for use with a medical device (e.g., generic batteries or monitors) are not considered accessories unless labeled or promoted for such use.
FDA encourages using pre-submission requests to obtain feedback before submitting Accessory Requests or De Novo classifications.
Recommendations
Determine whether an article qualifies as an accessory by evaluating its intended use with a parent device based on labeling and promotional materials.
Evaluate the risks associated with the accessory when used as intended with its parent device, considering both unique and parent-related risks.
Use the Accessory Request process for new or existing accessories to propose appropriate classifications, supported by evidence of risk profiles and proposed regulatory controls.
Submit De Novo requests for new accessory types lacking existing classifications, providing data on performance, risks, and mitigation measures.
Include clear and comprehensive labeling for accessories, specifying compatibility and performance with identified parent devices.
Regulatory Considerations
Classification of accessories should reflect their risks and required controls, independent of their parent device classification.
Accessories categorized as Software as a Medical Device (SaMD) must meet the same risk-based classification framework applied to other medical devices.
Manufacturers can request reclassification or exemption from 510(k) requirements for previously classified accessories through applicable FDA mechanisms.
FDA must respond to Accessory Requests for existing accessory types within 85 days and De Novo requests within 120 days, as specified in the FD&C Act.
The Paperwork Reduction Act governs the submission of accessory classification requests, requiring compliance with established timelines and documentation requirements.
An accessory is defined as a finished device that supports, supplements, or augments the performance of a parent device.
Accessories are classified based on their individual risk profiles when used with parent devices, which may differ from the classification of the parent device.
The De Novo process can be used for new accessory types with no existing classification, enabling lower-risk accessories to be classified in Class I or II.
Articles not specifically intended for use with a medical device (e.g., generic batteries or monitors) are not considered accessories unless labeled or promoted for such use.
FDA encourages using pre-submission requests to obtain feedback before submitting Accessory Requests or De Novo classifications.
Recommendations
Determine whether an article qualifies as an accessory by evaluating its intended use with a parent device based on labeling and promotional materials.
Evaluate the risks associated with the accessory when used as intended with its parent device, considering both unique and parent-related risks.
Use the Accessory Request process for new or existing accessories to propose appropriate classifications, supported by evidence of risk profiles and proposed regulatory controls.
Submit De Novo requests for new accessory types lacking existing classifications, providing data on performance, risks, and mitigation measures.
Include clear and comprehensive labeling for accessories, specifying compatibility and performance with identified parent devices.
Regulatory Considerations
Classification of accessories should reflect their risks and required controls, independent of their parent device classification.
Accessories categorized as Software as a Medical Device (SaMD) must meet the same risk-based classification framework applied to other medical devices.
Manufacturers can request reclassification or exemption from 510(k) requirements for previously classified accessories through applicable FDA mechanisms.
FDA must respond to Accessory Requests for existing accessory types within 85 days and De Novo requests within 120 days, as specified in the FD&C Act.
The Paperwork Reduction Act governs the submission of accessory classification requests, requiring compliance with established timelines and documentation requirements.
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.