get_decision_document
Fetch FDA regulatory decision documents (510k summaries, De Novo decisions, PMA approvals) by submission number, extracting text from PDFs for content not available via OpenFDA.
Instructions
Fetch FDA regulatory decision documents (not available via OpenFDA API). Downloads the PDF from FDA servers and extracts text content.
When to use: After finding a device submission via search_fda (e.g., dataset="device_510k" or "device_pma"), use the submission number from those results to retrieve the full decision document.
Args: document_type: Type of document to retrieve. submission_number: FDA identifier. Formats: 510k_summary: "K" + 6 digits (e.g., "K213456") denovo_decision: "DEN" + 6 digits (e.g., "DEN200001") pma_approval/pma_ssed/pma_supplement: "P" + 6 digits (e.g., "P200001") supplement_number: Required for pma_supplement only (e.g., "013"). max_length: Max text characters to return (default 8000). Increase for longer documents.
Examples: document_type="510k_summary", submission_number="K213456" document_type="pma_approval", submission_number="P200001" document_type="pma_supplement", submission_number="P200001", supplement_number="013"
Input Schema
| Name | Required | Description | Default |
|---|---|---|---|
| max_length | No | ||
| document_type | Yes | ||
| submission_number | Yes | ||
| supplement_number | No |
Output Schema
| Name | Required | Description | Default |
|---|---|---|---|
| result | Yes |