# Skills tagged "FDA" 9 skills with this tag. URL: https://rakenne.app/skill-tags/fda/index.md - [Clinical Trial Protocol (ICH E6 R3)](https://rakenne.app/skills/clinical-trial-protocol/index.md) — Draft clinical trial protocols compliant with ICH E6(R3) and ICH E8(R1). Covers study design, objectives, endpoints, eligibility criteria, estimand framework (ICH E9(R1)), statistical analysis plan, … - [Design Dossier Elaborator](https://rakenne.app/skills/design-dossier-elaborator/index.md) — Guided elaboration of design dossier, technical file, or device master record sections for medical devices: device classification, risk summary (ISO 14971:2019), essential principles (GSPR), … - [eCTD Cross-Module Verifier](https://rakenne.app/skills/ectd-cross-module-verifier/index.md) — Verify consistency and data integrity of eCTD pharmaceutical dossiers. Cross-checks Module 2 (Summaries) against Module 5 (Clinical Study Reports) to ensure study references, p-values, N-counts, … - [FDA 510(k) Premarket Notification — Substantial Equivalence Summary](https://rakenne.app/skills/fda-510k-submission-summary/index.md) — Draft and validate 510(k) premarket notification submissions for Class II medical devices. Structures the document per FDA guidance (Refuse to Accept checklist, 21 CFR 807.87) with device description, … - [FDA Submission Wizard](https://rakenne.app/skills/fda-submission-wizard/index.md) — Draft and validate FDA medical device submissions. Supports 510(k) Premarket Notifications (eSTAR format) with predicate comparison and substantial equivalence arguments, and PMA (Premarket Approval) … - [Food Labeling & Claims (FDA / USDA)](https://rakenne.app/skills/food-labeling-claims/index.md) — Draft and validate U.S. food product labels and labeling claims compliant with FDA 21 CFR 101, USDA FSIS, NLEA, FALCPA, and FASTER Act. Validates required label elements, allergen declarations, … - [GMP SOP & Validation Author](https://rakenne.app/skills/gmp-sop-validation-author/index.md) — Guided elaboration of GMP documentation — SOPs, validation protocol (IQ/OQ/PQ), and batch record template sections aligned to FDA 21 CFR 211 / EU EudraLex Vol 4 / WHO GMP. - [MDevSPICE Regulatory Readiness Narrative](https://rakenne.app/skills/mdevspice-regulatory-readiness-narrative/index.md) — Draft a regulatory readiness narrative for FDA (21 CFR 820), EU MDR, and IEC 62304; document evidence and alignment for audit or submission. - [QMS CAPA Tracker](https://rakenne.app/skills/qms-capa-tracker/index.md) — Draft and validate CAPA (Corrective and Preventive Action) reports for medical device quality management systems. Standardizes root cause analysis using 5 Whys or Fishbone (Ishikawa) methods, enforces … --- Back to [All Tags](https://rakenne.app/skill-tags/) | [Skill Library](https://rakenne.app/skills/)