FDA
Skill packages tagged with “FDA”
Design Dossier Elaborator
Guided elaboration of design dossier, technical file, or device master record sections for medical devices: risk summary, essential principles (GSPR), labelling, and traceability to risk file and standards per MDR Annex II/III and FDA design control.
eCTD Cross-Module Verifier
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, endpoints, and safety data are aligned before regulatory submission to FDA, EMA, or PMDA.
FDA 510(k) Premarket Notification — Substantial Equivalence Summary
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, predicate comparison, performance data summary, and labelling.
FDA Submission Wizard
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) dossiers with clinical and non-clinical data sections.
Food Labeling & Claims (FDA / USDA)
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, nutrient content claims against nutrition data, health claims, and organic/bioengineered disclosures.
GMP SOP & Validation Author
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
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
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 Effectiveness Check completeness, and validates CAPA structure against ISO 13485 and FDA 21 CFR Part 820 requirements.