Results for “fda-approval”

Screen products for FDA, EPA, USDA, CPSC, FCC, and other government agency requirements using AskRosetta. Use when checking regulatory compliance for US imports.

Drafts a Receipt of Franchise Disclosure Document proving FTC Franchise Rule compliance under 16 C.F.R. § 436. Produces an execution-ready acknowledgment with franchisee identification, delivery date, FDD version, exhibit inventory, and dual signature blocks. Use when creating FDD receipts, franchise disclosure acknowledgments, or Item 19 FPR attestations.

Drafts U.S. HACCP plans for food production under FDA or USDA regimes. Triggers on requests involving HACCP plans, food safety plans, hazard analysis, critical control points, FSMA compliance, seafood HACCP (21 CFR 123), or meat/poultry HACCP (9 CFR 417).

UAT Sign-off

Design, review, or troubleshoot Salesforce Approval Processes, covering entry criteria, approver routing, record locking, and recall behavior.

Use this skill when the user asks about FCRA adverse action procedures — what to do when a background check (MVR, criminal, drug test) returns information that may lead to denying employment or terminating a CDL driver. Covers the 5-business-day pre-adverse-action notice, FCRA Summary of Rights, final adverse action notice, state-specific add-ons (CA, NY, etc.), and how to handle disputes. Cite 15 USC § 1681 (FCRA) and 49 CFR 391.

Schema validation for notes. Checks against domain-specific templates. Validates required fields, enum values, description quality, and link health. Non-blocking — warns but doesn't prevent capture. Triggers on "/validate", "/validate [note]", "check schema", "validate note", "validate all".

Stops fantasy approvals, evidence-based certification - Default to "NEEDS WORK", requires overwhelming proof for production readiness

Implements Children's Online Privacy Protection Act (COPPA) compliance under 16 CFR Part 312. Covers verifiable parental consent methods including signed forms, credit card verification, government ID, knowledge-based authentication, and video call. Includes FTC safe harbor programs and enforcement actions. Keywords: COPPA, FTC, children, parental consent, safe harbor, verifiable consent.

Use only for developer-facing products; plan adoption loops, examples, templates, community, and proof artifacts

Check post-launch adoption for a published ORD package and recommend iterate, graduate, or archive

Centralized JSON validation for AGENT_SUCCESS_CRITERIA with defensive parsing and injection attack prevention (CVSS 8.2)

Use to build PNAS's Data Availability Statement and deposition plan — mandatory deposition of data in an approved repository at submission, accession numbers/DOIs, public + archived code, and materials sharing. "Available on request" is not sufficient for primary data.

针对医疗隐私和安全工作的HIPAA特定入口点。当任务明确围绕HIPAA、PHI处理、受保实体、BAA、违规态势或美国医疗合规要求时使用。

Combined verification — recite (description quality via cold-read prediction) + validate (schema compliance) + review (health checks). Use as a quality gate after creating notes or as periodic maintenance. Triggers on "/verify", "/verify [note]", "verify note quality", "check note health".

Imported skill approval from langchain

We need to output a SKILL.md file with the specified format.

Assess pharmacotherapy eligibility based on BMI/comorbidity

Walk a business/UAT approver through a plain-language demo of a verified feature and capture business acceptance signoff.

Validate whether an OSS tool is worth building through staged namespace, existing-solution, and feasibility review

Universal opt-out mechanism implementation across US state privacy laws. Covers Global Privacy Control (GPC) signal technical implementation, state-by-state recognition requirements, browser detection methods, authenticated vs unauthenticated handling, and compliance testing.

Acceptance Eval

Expert ITAR compliance advisor for US defense contractors, exporters, and manufacturers. Use this skill for any question about 22 CFR Parts 120-130, the United States Munitions List (USML), DDTC registration, export license applications (DSP-5/73/94), Technical Assistance Agreements (TAA), Manufacturing License Agreements (MLA), brokering regulations (Part 129), deemed export rules for foreign nationals, technology control plans, voluntary disclosures, violation mitigation, jurisdiction determination (ITAR vs EAR), or US Munitions List category scoping. Trigger even if the user doesn't say "skill" — any ITAR or US defense export control question should use this skill.

Use this skill when selecting or replacing an ELD provider. Covers the FMCSA Registered ELD list, evaluation criteria, common provider removals from the registered list, and the 60-day transition rule.

Determines if primary aldosteronism is confirmed based on upright plasma aldosterone ≤6 ng/dL (170 nmol/L) on day 4 at 10 AM of fludrocortisone suppression test, provided plasma renin activity ≥1 ng/mL/h and plasma cortisol concentration lower than the 7 AM value to exclude ACTH confounding. Use when reviewing FST results to diagnose PA; triggers include "FST", "upright aldosterone ≤6 ng/dL", "PRA ≥1 ng/mL/h", and "cortisol drop".

Drafts evaluation-ready U.S. federal RFP responses across all standard proposal volumes (cover letter, technical, cost/price, reps and certs). Enforces FAR compliance, CPARS references, and Section L/M alignment. Use when preparing federal solicitation submissions, responding to government RFPs, or drafting procurement bids.