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

 

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.

πŸ“Œ 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.

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

πŸ“± 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.

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

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

Regulatory & Post-Market Compliance

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

πŸ“œ FDA expects continual data collection, real-time monitoring, and evidence-based iteration.

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

Commercialization Strategy for SaMD Startups

πŸ’Ό Establish quality and security frameworks early—even in prototyping.

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

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

πŸ’Ό 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