Navigating FDA Software as a Medical Device (SaMD) Precertification Pathway

by석아산 • • 2 min read
0

 

A four-panel comic titled “Navigating FDA SaMD Precertification.” Panel 1: A man says, “Our medical software needs FDA approval…” and a woman replies, “It could be classified as a SaMD.” Panel 2: A woman holding a paper labeled “SaMD Precertification” says, “We’ll go down the SaMD precertification pathway!” Panel 3: The man says, “With monitoring and documentation, we’ll qualify!” as the woman nods. Panel 4: The team cheers, saying, “Now to navigate the steps…” and “Let’s do it!”

Navigating FDA Software as a Medical Device (SaMD) Precertification Pathway

As digital health solutions become more advanced, many software platforms now qualify as Software as a Medical Device (SaMD)—falling under FDA oversight.

To streamline innovation while ensuring patient safety, the FDA introduced a voluntary precertification program tailored to SaMD developers.

This post guides you through the SaMD precertification pathway, helping your team align with regulatory expectations and prepare for market entry.

📌 Table of Contents

What Qualifies as SaMD?

🧠 According to the International Medical Device Regulators Forum (IMDRF), SaMD refers to software intended for medical purposes that is not part of a hardware medical device.

🔬 Examples include AI tools that detect retinal disease from images, or apps that monitor medication adherence for chronic conditions.

📱 Mobile health apps, wearables, and remote diagnostic platforms may all fall into this category depending on their claims and risk profiles.

Overview of the FDA Precertification Program

✅ The SaMD Precert program aims to shift regulatory focus from product to developer—emphasizing organizational excellence.

✅ Instead of evaluating each product, the FDA evaluates a developer’s software culture, quality systems, and track record.

✅ In exchange, precertified companies benefit from streamlined review processes and more flexible submission pathways.

Core Components of the Precert Pathway

🧩 Excellence Appraisal: The FDA assesses the developer’s culture of quality and organizational processes.

📊 Streamlined Review: Risk-based levels determine whether a SaMD needs premarket review or not.

📈 Real-World Performance Analytics (RWPA): Ongoing postmarket monitoring is required to ensure software effectiveness and safety in the field.

Regulatory & Post-Market Compliance

📜 Even precertified developers must maintain full traceability for SaMD updates, risk mitigation strategies, and incident reporting.

📜 FDA expects continual data collection, real-time monitoring, and evidence-based iteration.

📜 Tools like AI model version control, clinical validation logs, and user behavior metrics are essential.

Commercialization Strategy for SaMD Startups

💼 Establish quality and security frameworks early—even in prototyping.

💼 Map features to FDA risk classifications (e.g., diagnostic vs. monitoring vs. support).

💼 Build an RWPA dashboard into your SaaS admin portal for both compliance and clinical credibility.

💼 Plan your go-to-market roadmap to include payer partnership and CPT code alignment if reimbursement is sought.

Explore SaMD Development & Regulatory Tools











Keywords: SaMD precertification, FDA digital health regulation, software as medical device, AI medical compliance, real-world performance monitoring

4.94 / 169 rates
Previous Post Next Post