FDA Guidance

Three FDA combination product guidance documents, converted to ADAP-anchored agentic format. Every sentence and section carries a permanent coordinate — an AI agent can quote, cite, and link back to the exact line, and a human reader can click that citation to land precisely there.

For AI Agents — Navigation

Navigate: Select a document below → fetch it → read the Protocol block → read the Address Index → cite with path-form coordinates.

Citation format: [page-url]/[COORDINATE] — forward slash. Example: https://tasset.ai/agenticweb/FDA-guidance/request-for-designation.html/U001.D006.PG1.S1.P1.L1

Page references: A line reading [PAGE N] marks where PDF page N of the original FDA guidance begins — cite the ADAP coordinate together with this page number when a regulatory-style citation ("see p. N") is useful.

Documents

How to Write a Request for Designation (RFD) FDA Guidance for Industry, April 2011. How sponsors request a binding classification and/or center assignment determination for a drug, device, biological, or combination product. Plain-text version (Protocol + Address Index): request-for-designation.txt
Principles of Premarket Pathways for Combination Products FDA Guidance for Industry and FDA Staff, January 2022. PMA, De Novo, 510(k), NDA, ANDA, and BLA pathway availability for device-, drug-, and biologic-led combination products. Plain-text version (Protocol + Address Index): premarket-pathways-combination-products.txt
Unique Device Identifier (UDI) Requirements for Combination Products FDA Draft Guidance for Industry & FDA Staff, June 2025. UDI and National Drug Code (NDC) requirements for device constituent parts of combination products. Plain-text version (Protocol + Address Index): udi-requirements-combination-products.txt

FDA Guidance Demo for Medical Device Manufacturers

The prompt below reads three FDA combination product guidance documents (Request for Designation, Premarket Pathways, and UDI Requirements) in ADAP-anchored format. Add your own prompt, question, request, or workflow in the bracketed section, then copy and paste the whole thing into Claude to receive guidance that cites its exact source coordinate for every claim: accurate, attributable, and traceable back to the exact sentence in the source document.

Read https://tasset.ai/agenticweb/FDA-guidance/request-for-designation.txt, https://tasset.ai/agenticweb/FDA-guidance/premarket-pathways-combination-products.txt, and https://tasset.ai/agenticweb/FDA-guidance/udi-requirements-combination-products.txt. These are FDA guidance documents on combination product classification, premarket pathways, and UDI requirements. [ADD YOUR QUESTION, WORKFLOW, OR REQUEST HERE — e.g. "Is my drug-device combination product likely device-led or drug-led, and what premarket pathway applies?"] For every claim, cite using ADAP path-form coordinates as clickable links pointing to the .html source, not the .txt source, e.g. [COORDINATE](https://tasset.ai/agenticweb/FDA-guidance/premarket-pathways-combination-products.html/COORDINATE). Use direct quotes — reproduce the exact text character for character. Cite the PDF page number alongside the coordinate where useful. I will click your citations to verify them at the exact highlighted location in the source document.

All Agentic Web Documents