Dovetail Regulatory

Get details for a specific 510(k) number from the FDA database. Use this to inspect the device record and retrieve the parsed summary URL that can then be passed to `read_summary`.

get_510k

Check the status of a previously started AGENT run. Pass the `agent_run_id` returned by one of the `run_*_agent` tools. The result is either `working`, `completed` with final output, or `failed` with an error message.

get_agent_run_result

Get the complete database entry for an assistant process. Use this when the user refers to a staged or proposed value. The process state contains changes that have not been applied to documents yet, so inspect it before searching document metadata for that value. Provide the process, organization, and device IDs that identify the process context.

get_assistant_process

Get basic device information and characteristics. Returns high-level device metadata such as name, description, market, and components. Prefer `read_data_key` or `read_document` if you need specific regulatory content rather than an overview.

get_device

Get the computed dashboard for an organization or device. Omit `device_id` for the organization dashboard. Provide `device_id` when the user wants the dashboard scoped to a specific device.

get_dashboard

List available data-key definitions. A data-key id can belong to multiple document records. The id identifies the field definition; each document version holds its own value. Use a selected `document_id`/`version_id` pair when reading or editing one.

list_data_keys

Get the devices the authenticated user can access in one organization. Use this to identify the device ID you need before reading data keys, documents, templates, or running an AGENT against a specific device. Call `get_organizations` first if you need an organization ID.

get_devices

List document templates available for the configured device. Use this if you need to understand which template keys are available in the system before reading a template or creating related content.

list_document_templates

List all available documents for a device in JSON format. Returns a lightweight list with `title`, `id`, and `templateKey`. Use `read_document_metadata` for revision metadata and `read_document` for full document content.

list_documents

Get the functional groups for an organization. Use this when you need the available functional groups before creating or updating documents that belong to a specific function or team.

get_functional_groups

Get the organizations the authenticated user can access. Use this to understand which organizations are available to the current user before listing or working with devices and related resources.

get_organizations

List skills visible to you in an organization. Results include skill IDs, descriptions, visibility, and your enabled state, including skills you disabled. Use `mine` to find skills you created, then check `canEdit` before editing. Search matches names and descriptions. Markdown bodies are not included in this list; use `read_skill` for the full content.

list_skills

List all standards available to the current server.

list_standards

Get tasks for the authenticated user or the whole organization. `scope="mine"` returns tasks assigned to the current user. Use `scope="all"` when the user explicitly needs organization-wide task visibility. Provide `device_id` to include tasks for that device plus organization-wide tasks.

get_tasks

Get team members for an organization. Use this when you need collaborators in a specific organization, for example to identify reviewers or document owners across that org.

get_team_members

Read the text content of a parsed 510(k) summary file. Pass the `Parsed PDF URL` returned by `search_510k_summaries` or `get_510k`. Do not use the original FDA 510(k) URL here.

read_summary

Get the configuration for a specific data key. Use this to inspect the data key type, guideline text, related data keys, and visibility rules before reading or editing the value.

read_data_key_configuration

Get the value for a given data key. By default this returns the first 50,000 characters with a summary when the value is longer. Choose a document source with `document_id` and `version_id`, or an assistant-process source with `assistant_process_id`, `org_id`, and `device_id`.

read_data_key

Read the full body for a document version. Live editable drafts return the current Dovetail document JSON. Stored revisions return the saved Dovetail document JSON when available. Uploaded documents return their stored parsed markdown. If `version_id` is omitted, the latest draft is preferred and otherwise the latest retrievable revision is returned. For Dovetail document JSON, `from_node` starts reading at a zero-based top-level node index. Use `read_document_metadata` for version, author, and approver metadata.

read_document

Pass the Dovetail document UUID as document_id. Read comment threads from the document with pagination. <tool-input> from_node: the index of the first thread to read (zero-based). The tool will read from that thread until the chunk size limit is reached. </tool-input> <tool-result> totalThreadCount: the total number of threads in the document threadRange: the range of threads that was read as [from, to) (zero-based, exclusive) threads: an array of thread objects, each containing: - id: unique thread identifier - nodeRange: the location of the thread in the document, or null if the thread is not annotated - content: the content of the document that is marked by the thread, or null if the thread is not annotated - resolvedAt: ISO timestamp when thread was resolved, or null if unresolved - createdAt: ISO timestamp when thread was created - updatedAt: ISO timestamp when thread was last updated - comments: array of comment objects, each containing: - id: unique comment identifier - content: the comment text content - userId: identifier of the user who created the comment - createdAt: ISO timestamp when comment was created - updatedAt: ISO timestamp when comment was last updated - data: optional metadata object associated with the thread </tool-result> <thread-location> Threads are associated with specific ranges of text in the document using the `inlineThread` mark. The `inlineThread` mark has a `data-thread-id` attribute that references the thread's ID. To find where a thread is located in the document, use read_document to read the document content and look for text nodes with an `inlineThread` mark whose `data-thread-id` matches the thread ID. </thread-location> <important-rules> To read from the beginning, call this tool with from: 0. Continue reading with higher from values to paginate through all threads. Use this tool to understand existing comments before making edits with edit_document_comments. </important-rules>

read_document_comments

Read document metadata for a document and its retrievable versions. Use this to inspect retrievable versions, authors, approvers, and revision details without fetching the full document body.

read_document_metadata

Look up a document template and the data keys that are part of it. Use this to understand which template keys and fields are part of a given document so you can create or review the relevant content sequentially. Always call `read_data_key_configuration` separately for each returned data key before filling out answers; the template response only identifies the fields, while the data key configuration provides the field-specific guidance, type, context, and constraints needed to complete them correctly.

read_document_template

Read a visible skill's full markdown instructions and metadata. Use `list_skills` to find the skill ID. A skill you disabled remains readable if you can still access it. The backend checks organization membership and skill visibility.

read_skill

Read a standards file by ID. Returns a paged view of the standard content. Use this to review the actual text of a standard after locating the file via `list_standards` or `grep_search_standards`.

read_standard

Get the device traceability matrix payload. Returns the backend traceability matrix JSON for a device, including chains, relations, and Mermaid definitions. Set `plain_mermaid=true` to remove Mermaid styling from `chains[].mermaidDefinition`. Mermaid click links are omitted by default because MCP clients cannot use them; set `include_mermaid_links=true` to include source links.

get_traceability_matrix

Search recalled expert knowledge relevant to the current device. This looks across organization-specific memory and the configured expert knowledge namespace to return concise retrieved context for the query.

memory_recall

Search 510(k) summaries by semantic similarity to the query. The query should be a short description of the device and the relevant characteristics you want to match. Results include similar devices and metadata such as organization, product code, received year, FDA URL, parsed summary URL, and similarity score.

search_510k_summaries

Run a fast regex search across document and data key content. This is best for finding exact text matches or regex patterns and is more precise than manually scanning with `read_document` or `read_data_key`. The query must be a valid regex, so escape special characters when needed.

grep_search_documents

Run a fast regex search across standards content. This is best for finding exact text matches or regex patterns inside standards. The query must be a valid regex, so escape special characters when needed.

grep_search_standards

Start the Expert Reviewer and return an `agent_run_id`. Use this when you need an agentic expert review of regulatory content or reasoning for a specific device. Specify the device name or ID and the review goal in `request`. For an organization-wide review, state that scope explicitly. The agent can discover the device or ask for clarification if needed. This call starts the background run only. Use `get_agent_run_result` with the returned handle until the status is `completed`.

run_expert_reviewer_agent

Start the Predicate Researcher and return an `agent_run_id`. Use this when you need agentic predicate or FDA research for a specific device. Specify the device name or ID and the research goal in `request`. The agent can discover the device or ask for clarification if needed. This call starts the background run only. Use `get_agent_run_result` with the returned handle until the status is `completed`.

run_predicate_researcher_agent

Start the Standards and Guidances Researcher and return an `agent_run_id`. Use this when you need agentic research across standards and guidances for a specific device. Specify the device name or ID and the research goal in `request`. The agent can discover the device or ask for clarification if needed. This call starts the background run only. Use `get_agent_run_result` with the returned handle until the status is `completed`.

run_standards_and_guidances_researcher_agent