FDA 510(k) Glossary · device type

SaMD - Software as a Medical Device

SaMD (Software as a Medical Device) is software intended to be used for one or more medical purposes that performs these purposes without being part of a hardware medical device. SaMD is increasingly regulated through the FDA 510(k) pathway, with PCCP authorization available for AI/ML-based SaMD that requires iterative algorithm updates.
Dataset Insight - 510k Database (166,200 records, 1980–2025)
SaMD devices are cleared across all FDA panels. The Radiology panel has the highest concentration of AI/SaMD clearances. 91 SaMD submissions in the dataset carry PCCP authorization.

Definition

Software as a Medical Device (SaMD) is defined by the International Medical Device Regulators Forum (IMDRF) as software intended to be used for one or more medical purposes that performs these purposes without being part of a hardware medical device. In the United States, the FDA regulates SaMD under the Federal Food, Drug, and Cosmetic Act.

Examples of SaMD

  • AI-powered imaging software that analyzes CT or MRI scans for diagnostic findings
  • Clinical decision support software that recommends treatment options based on patient data
  • Remote patient monitoring applications that detect arrhythmias or glucose anomalies
  • Computer-aided detection (CAD) systems for radiology
  • Software that calculates drug dosages based on patient-specific parameters

FDA Regulatory Pathway for SaMD

Most SaMD products are regulated as Class II medical devices and cleared through the 510(k) premarket notification pathway. The FDA evaluates SaMD using the same substantial equivalence framework as hardware devices, comparing the software's intended use and algorithm characteristics to a predicate device.

For novel SaMD without valid predicates, the De Novo Classification pathway provides an alternative route. For AI/ML-based SaMD that requires ongoing algorithm updates, the PCCP framework allows manufacturers to pre-specify planned modifications.

Dataset Insights

The 510k Database dataset includes SaMD submissions across multiple FDA review panels. The Radiology panel has seen the fastest growth in SaMD clearances, driven by AI imaging software under product code QIH. The Neurology panel has the highest concentration of NSE decisions for AI/SaMD submissions.

FDA References

Related Terms

PCCP - Predetermined Change Control Plan - 510(k) Premarket Notification - De Novo Classification - Substantial Equivalence

Frequently Asked Questions

Software as a Medical Device (SaMD) is software intended to be used for one or more medical purposes - such as diagnosing, treating, or monitoring a condition - without being part of a hardware medical device. Examples include AI-powered diagnostic imaging software, clinical decision support tools, and remote patient monitoring applications.

Many SaMD products are regulated as Class II medical devices and cleared through the 510(k) premarket notification pathway by demonstrating substantial equivalence to a predicate device. Higher-risk SaMD may require Premarket Approval (PMA). The FDA has also established the De Novo pathway for novel SaMD without valid predicates.

SaMD operates independently to perform medical functions - such as an app that analyzes retinal images to detect diabetic retinopathy. Software in a medical device (SiMD) drives or controls a hardware device - such as software controlling a pacemaker. SaMD is regulated separately from SiMD.

The PCCP (Predetermined Change Control Plan) framework was created specifically to address the iterative nature of AI/ML-based SaMD. Because these devices learn and adapt from real-world data, the FDA introduced PCCP to allow manufacturers to pre-specify planned algorithm modifications without requiring a new 510(k) submission for each update.