FDA Software as a Medical Device (SaMD) Guide

 

Do You Know the Difference Between a "Wellness App" and an "Illegal Medical Device"?

Download the 2026-2027 FDA Software as a Medical Device (SaMD) Readiness Kit.

Navigate the QMSR. Master Design Controls. Implement AI Change Plans.

The "Regulatory Debt" Trap.

Most HealthTech founders make a fatal mistake: They build the MVP first, then hire a consultant to "fix the compliance" later.

In the eyes of the FDA, this is impossible.

If you cannot prove that your software was developed under Design Controls (21 CFR 820.30) from the very beginning, your code is considered "Adulterated." You cannot simply retro-fit a Quality System onto an existing codebase. You often have to scrap the code and start over.

The Legal Attorney FDA SaMD Readiness Kit is the strategic framework you need to build compliance into your product roadmap, ensuring you reach 510(k) clearance without rewriting your entire application.

What You Get Inside the Master File:

The QMSR & ISO 13485 Harmonization Strategy (Article II)
Updated for the 2026 FDA transition from QSR to QMSR (Quality Management System Regulation). This module establishes the mandated Design Control workflows—User Needs, Design Inputs, and Validation—that satisfy both US and International standards.

The AI Predetermined Change Control Plan (PCCP) (Article V)
A cutting-edge regulatory strategy for AI startups. This section defines how to draft a PCCP, allowing you to retrain and update your Machine Learning models post-launch without triggering a new, expensive FDA submission for every tweak.

The Cybersecurity "Refuse to Accept" Protocols (Article IV)
Since the passing of the "Patch Act," cybersecurity is a hard gate. This kit includes the mandatory requirements for Software Bill of Materials (SBOM), vulnerability disclosure, and threat modeling that you must have to get your application past the FDA mailroom.

The Classification Decision Matrix (Article I)
A clear logic flow to determine if your software is a Class I, II, or III device, or if you can claim the coveted "General Wellness" or "Clinical Decision Support" exemptions to avoid FDA regulation entirely.

The Pre-Submission Checklist (Exhibit A)
A physical sign-off sheet for your Regulatory Lead. It covers the exact artifacts—Traceability Matrices, Risk Management Files, and Clinical Evidence protocols—you need to have in hand before you schedule your first meeting with the FDA.

Why MedTech Founders Need This Specific Framework:

It Aligns Engineering with Quality
Developers hate documentation. This framework translates regulatory speak into engineering tasks (e.g., "Jira Ticket = Design Input"), helping you implement a compliant SDLC without slowing down innovation.

It Prepares You for Due Diligence
HealthTech investors know the risks. If you enter a Series A pitch without a clear Regulatory Strategy and a structured Data Room (DHF), you will not get funded. This document builds that structure.

It Mitigates Risk Management (ISO 14971)
The FDA requires you to prove the "Benefit-Risk Ratio." Our framework integrates Hazard Analysis directly into the lifecycle, ensuring you identify patient safety risks before they become lawsuits.

Build for Patients. Build for Approval.

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Frequently Asked Questions

Does this replace a Regulatory Consultant?

No. You will eventually need a specialized RA/QA consultant to write the actual 510(k) submission. This Kit is the Internal Framework that prepares your company so the consultant can actually do their job. Without this, the consultant will tell you to start over.

Is this updated for the new QMSR rules?

Yes. The FDA recently harmonized 21 CFR 820 with ISO 13485 (the QMSR). This kit reflects that terminology and structure, ensuring you aren't using outdated 1990s compliance logic.

What about AI?

This is specifically designed for AI. Article V addresses the unique challenges of "Black Box" algorithms and the new PCCP pathway that allows for continuous learning models.