fda-samd

What problem does it solve?

This Skill helps engineers and product owners determine the regulatory status of their software as a medical device (SaMD), plan submission pathways, design under quality systems, and maintain post-market compliance, ensuring adherence to FDA regulations.

Core Features & Use Cases

• Regulatory Assessment: Determine if software is regulated under FDA as a medical device, with analysis of key terms and regulations.
• Premarket Pathways: Guide on which premarket pathway (510(k), De Novo, PMA, HDE, IDE) applies to a specific SaMD based on risk and type.
• Quality System: Assist in establishing quality systems under QMSR/ISO 13485, including risk management and software lifecycle processes.
• Machine Learning Considerations: Provide guidelines for Good Machine Learning Practice (GMLP) and transparency in AI-enabled medical devices.
• Post-Market Surveillance: Outline obligations for medical device reporting, field corrections, recalls, and surveillance plans.

Quick Start

Apply the fda-samd skill to analyze whether a software solution designed to predict patient outcomes requires FDA regulation and to determine the appropriate premarket pathway.