Software as a Medical Device (SaMD) Registration in the United States (US)

Securing regulatory clearance for Software as a Medical Device (SaMD) in the United States requires an in depth understanding of FDA expectations, software classification, and the 510(k) pathway. Masuu Global Solutions works closely with digital health innovators to streamline regulatory steps, ensure full compliance, and accelerate market entry.

SaMD Registration in the U.S. – Overview

Topics Covered
  • What qualifies as SaMD?
  • Which SaMD risk class requires a 510(k)?
  • What does the 510(k) submission process involve?
  • How long does FDA clearance remain valid?

Is My Software Considered SaMD?

According to the International Medical Device Regulators Forum (IMDRF), software qualifies as SaMD when:
  • It is designed to perform one or more medical functions (e.g., diagnosis, monitoring, analysis).
  • It performs these functions independently of any hardware medical device.

If your software influences clinical decision making or patient management without relying on hardware, it likely meets the definition of SaMD.

Which SaMD Risk Class Requires a 510(k)?

Classification determines your regulatory pathway. In the U.S.:
  • Class II SaMD typically requires a 510(k) premarket submission.
  • The goal is to demonstrate substantial equivalence to an already cleared device (predicate).
  • This ensures that your product meets applicable standards for safety and effectiveness before reaching the market.

Masuu Global Solutions assists with classification, predicate identification, and risk based pathway selection.

SaMD Registration and the 510(k) Process

The 510(k) process is a structured submission demonstrating that your SaMD is comparable to an existing, legally marketed device. Key steps include:
  • Preparing complete software documentation (architecture, validation, cybersecurity, risk management).
  • Compiling performance data and clinical justification, where applicable.
  • Submitting through FDA’s eCopy or eSTAR system.
  • Addressing FDA queries, such as RTA (Refuse-to-Accept) or Additional Information requests.

Once the FDA issues a “Substantial Equivalence” determination, the device is considered cleared and listed in FDA’s public 510(k) database.

How Long Is FDA Clearance Valid?

An issued 510(k) clearance remains valid indefinitely unless:
  • The SaMD undergoes major functional, design, or intended use changes
  • Regulatory updates require re evaluation
  • FDA requests updated information as part of ongoing safety oversight

Masuu Global Solutions provides ongoing compliance support to ensure long term regulatory alignment.

Masuu Global Solutions – U.S. SaMD Registration Services

  • Extensive hands on experience with diverse 510(k) submissions
  • Skilled in compiling FDA aligned software documentation packages
  • Strong capability in preparing eCopy/eSTAR ready submissions
  • Timely and predictable delivery of all submission components
  • Continuous monitoring of evolving FDA software and SaMD requirements

Advantages

  • End to end U.S. regulatory strategy for SaMD
  • Qualification and classification support
  • Detailed predicate device research
  • Substantial equivalence justification and documentation
  • U.S. FDA gap assessments for software and QMS artifacts
  • Full compilation of 510(k) technical files following FDA’s software guidance
  • Creation, validation, and submission of eCopy / eSTAR packages
  • Direct communication support during FDA review
  • Management of RTA and Additional Information responses
  • Establishment registration and device listing services
  • FURLS database maintenance
  • U.S. legal representative (LR) support
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