What FDA submission pathways does this skill cover?

The skill provides guidance for 510(k) (Traditional, Special, and Abbreviated), De Novo, and PMA (Premarket Approval) pathways, including decision matrices to help you select the appropriate one.

Can this skill automate regulatory documentation?

While it doesn't write the final legal documents, it provides scripts to track submission milestones, templates for compliance, and checkers to assess your project against 21 CFR 820 requirements.

Does it help with Software as a Medical Device (SaMD)?

Yes, it specifically addresses SaMD concerns including IEC 62304 software documentation, HIPAA technical safeguards, and FDA cybersecurity premarket requirements.

How does it assist with HIPAA compliance?

It provides a framework for assessing administrative, physical, and technical safeguards, specifically for devices that handle Protected Health Information (PHI).

FDA Consultant Specialist

Name: FDA Consultant Specialist
Author: zhangzhang-111-i

byzhangzhang-111-i

0•

보안 및 테스팅

Provides regulatory guidance for medical device manufacturers navigating FDA pathways, quality systems, and cybersecurity compliance.

This skill acts as a specialized consultant for medical device companies, offering deep expertise in FDA regulatory pathways like 510(k), PMA, and De Novo. It assists with Quality System Regulation (QSR) compliance under 21 CFR 820, HIPAA security assessments, and medical device cybersecurity requirements. By providing structured frameworks for design controls, risk management, and submission tracking, it helps developers and regulatory teams ensure their software and hardware meet stringent medical safety standards from the design phase through post-market surveillance.

주요 기능

01Regulatory pathway decision framework for 510(k), PMA, and De Novo submissions

02QSR (21 CFR 820) compliance assessment and design control workflows

03Cybersecurity threat modeling and SBOM guidance for premarket requirements

04HIPAA technical safeguard risk analysis for connected medical devices

05Automated submission tracking and milestone management scripts

060 GitHub stars

사용 사례

01Performing a technical security assessment to ensure a medical device complies with HIPAA and FDA cybersecurity mandates

02Conducting a gap analysis against Quality System Regulations (QSR) to prepare for a regulatory audit

03Determining the correct FDA submission type and identifying predicate devices for a new SaMD (Software as a Medical Device)

What are Skills?·How to Install

Install with 🐟 Skill.Fish

npx skillfish add zhangzhang-111-i/claude-skills111 fda-consultant-specialist

For use in Claude.ai and ChatGPT

주요 기능

01Regulatory pathway decision framework for 510(k), PMA, and De Novo submissions

02QSR (21 CFR 820) compliance assessment and design control workflows

03Cybersecurity threat modeling and SBOM guidance for premarket requirements

04HIPAA technical safeguard risk analysis for connected medical devices

05Automated submission tracking and milestone management scripts

060 GitHub stars

사용 사례

01Performing a technical security assessment to ensure a medical device complies with HIPAA and FDA cybersecurity mandates

02Conducting a gap analysis against Quality System Regulations (QSR) to prepare for a regulatory audit

03Determining the correct FDA submission type and identifying predicate devices for a new SaMD (Software as a Medical Device)