- Home
- Remedies
- Medicinal Devices
- Digital Health/SaMD
- Software as a Medical Device (SaMD) Registration in the US
Software as a Medical Device (SaMD) Registration in the United States (US)
SaMD registration in the United States requires a clear understanding of the U.S. Food and Drug Administration (FDA) regulations and the appropriate regulatory pathways, including the 510(k) clearance, De Novo, or PMA processes. Compliance with FDA SaMD requirements is essential to demonstrate safety, effectiveness, and performance, ensuring successful market entry and long-term regulatory alignment.
SaMD Registration in the US – Overview
Answered on this page:
- Is my software an SaMD?
- Which risk class of SaMD requires a 510(k)?
- SaMD registration and compliance – the 510(k) process
- How long is the clearance valid?
Is My Software an SaMD?
According to the International Medical Device Regulators Forum (IMDRF), Software as a Medical Device (SaMD) is defined as:
- Software intended to be used for one or more medical purposes that performs these functions without being part of a hardware medical device.
- If your software fits this definition, it may be subject to FDA medical device regulations under the SaMD category.
Which Risk Class of SaMD Requires a 510(k)?
Determining the risk classification of your SaMD is a critical step in the registration process. Once confirmed as SaMD, the next step is identifying the appropriate regulatory pathway for U.S. market entry.
SaMD products are classified by risk level (Class I, II, or III). Class II SaMD—considered moderate risk—requires a 510(k) clearance. This involves proving substantial equivalence to a legally marketed predicate device. The 510(k) process confirms that your SaMD meets safety and performance expectations before commercialization.
SaMD Registration and Compliance – The 510(k) Process
The 510(k) submission is a formal application that demonstrates your SaMD is substantially equivalent to a previously cleared device. Upon review, the FDA issues a decision letter via email. If found equivalent, your software is officially “cleared” and added to the public 510(k) database along with a summary of the submission.
A visual overview of the 510(k) steps typically includes:
- Determine device classification and predicate
- Prepare technical documentation and testing data
- Submit the 510(k) to the FDA
- Respond to FDA queries (if any)
- Receive clearance letter and database listing
How Long Is the Clearance Valid?
A 510(k) clearance remains valid indefinitely, provided there are no significant changes to the device design, intended use, or regulatory landscape. However, the FDA may require periodic updates or reports to ensure continued compliance and safety, especially for software updates or feature changes.
Successfully registering SaMD in the U.S. requires a deep understanding of:
- SaMD definitions and classification
- FDA risk-based requirements
- The 510(k) submission and review process
Engaging with specialized SaMD regulatory consultants can help streamline your journey, reduce time to market, and ensure compliance with evolving FDA expectations.
SaMD Registration in the US
- Expertise
- Advantages
- Comprehensive US FDA Regulatory strategy for SaMD.
- SaMD classification.
- Predicate device identification.
- Establishing substantial equivalence with the predicate device.
- Gap analysis for US FDA compliance.
- Compilation of 510(k) technical file, according to the US FDA’s Premarket Submissions Guidance for Software.
- Creation of the eCopy/eSTAR template.
- Validation and submission of the eCopy/eSTAR template.
- Liaising services for device approval.
- Support for RTA response and AINN deficiencies.
- Consultation services for addressing deficiencies.
- Establishment registration with the US FDA.
- Device listing and FURLS database maintenance.
- Legal Representative (LR) services.
- Extensive experience with diverse 510(k) registrations.
- Expertise with 510(k) compilation, as per the US FDA’s Premarket Notification (510[k]) requirements.
- Additional support for handling 510(k) queries.
- On-time submission of deliverables.
- Up to date with the US FDA’s new amendments on SaMD.
