92 tagged fda, measured the same way as everything else here.
Browse within: ai-skills 53compliance 53cosmetics 53adverse-events 32drug-safety 32
Skill Claude CodeCodex
Reason about SaMD (Software as a Medical Device) regulatory compliance for FDA, EU MDR, and global submissions. Use when the user asks about IEC 62304 safety classification, ISO 14971 risk management, 21 CFR 820/QMSR quality system requirements, Design History File structure, 510(k)/De Novo/PMA pathway selection…
Skill Claude CodeCodex
Scaffold a new MCP tool definition. Use when the user asks to add a tool, create a new tool, or implement a new capability for the server.
Skill Claude CodeCodex
Canonical reference for the unified Context object passed to every tool and resource handler in @cyanheads/mcp-ts-core. Covers the full interface, its RequestContext base, all sub-APIs (ctx.log, ctx.state, ctx.requestInput, ctx.inputs, ctx.enrich, ctx.content), and when to use each.
Skill Claude CodeCodex
Design the tool surface, resources, and service layer for a new MCP server. Use when starting a new server, planning a major feature expansion, or when the user describes a domain/API they want to expose via MCP. Produces a design doc at docs/design.md that drives implementation.
Skill Claude CodeCodex
Answer questions about FDA drug approvals — the basis for approval, the trials, the endpoints, the regulatory pathway, the adverse events flagged in the medical review. Use when the user asks about a specific FDA-approved drug (especially one approved 2021–2024), wants the actual evidence behind an approval rather…
Skill Claude CodeCodex
Answer questions about U.S. nonprofit hospital financials, beds, staffing, charity care, and community benefit by querying CMS Medicare Cost Reports (HCRIS) and IRS Form 990 Schedule H filings. Use when the user asks about a specific hospital's cost-report numbers, peer context across hospitals, the meaning of a…
Skill Claude CodeCodex
Use when selling infant formula (0-6 months), follow-on formula (6-12 months), growing-up milk, toddler milk, specialty formula (hypoallergenic, organic, A2, goat, soy, premature) in any market, navigating EU 609/2013 + 2016/127, FDA 21 CFR 106-107, NMPA registration, WHO Code marketing restrictions, or recall…
Skill Claude CodeCodex
Use when selling connected products, IoT devices, smart home hardware, industrial control systems, or any product with digital elements in EU/UK/US/APAC markets; checking CRA (Cyber Resilience Act) conformity obligations; assessing RED cybersecurity delegated regulation (EU) 2022/30 and EN 18031 harmonised standards…
Skill Claude CodeCodex
Use when selling firearms, ammunition, replicas, deactivated weapons, airsoft, airguns, paintball markers, BB guns, or firearm parts/accessories in any market, checking BATFE/ATF rules, EU Firearms Directive 2017/853 categorization, UK Firearms Act Section 5 prohibitions, ITAR/EAR export controls, or marketplace bans.