MCP App StoreMCP App Store
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Automated checklist and structured workflow to assess FDA labeling compliance for foods, drugs, dietary supplements and medical devices; produces findings with
This skill provides a structured, regulatory-first workflow to evaluate product labeling against FDA requirements (FDCA and relevant 21 CFR sections). It guides the agent through classification, principal display panel (PDP) checks, information panel and nutrition/drug/device-specific checklists, claim-by-claim compliance analysis, and a findings table with severity, citations, and prioritized corrective actions. The output is suitable for internal audits, pre-submission review, or preparing responses to FDA inquiries.
Use this skill when reviewing label artwork or PDFs before launch, auditing existing labels for enforcement risk, evaluating claim language for possible misbranding or unapproved drug claims, or preparing documentation for 510(k) or other regulatory submissions. It's most useful for compliance reviewers, regulatory affairs teams, and legal counsel supporting labeling.
Best used by agents with document-reading and table-generation capabilities (any LLM agent that can parse label text/images and output structured tables).
FDA labeling compliance review skill — a detailed static checklist/workflow for assessing product labels against FDCA, 21 CFR, and FDA guidance. Covers drugs, foods, dietary supplements, and medical devices with specific CFR citations. No bundled scripts; purely reference content. Well-organized with numbered steps, quick start section, and common pitfalls, but monolithic without progressive disclosure or references directory.
Clean static skill, no security concerns. Niche regulatory compliance domain limits broad usefulness. Good internal structure but could benefit from splitting detailed checklists into references/ files for progressive disclosure.
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