Exactly how many Software as a Medical Devices (SaMD) have been officially cleared by the FDA and reached the market? The answer to that question that I’ve given and heard from others over the last four years is, “Gee, I dunno. I’ve never seen that list compiled and I’m not sure you can get it right out of the FDA’s public databases.”
In the absence of an official list, I, Randy Horton, Chief Solutions Officer here at Orthogonal, and Brian Binkowski, a SaMD consultant with over a decade of industry experience, have made our own list – and we’d like your help in refining it. View our current draft list in full here: List of 483 FDA-Cleared Software as a Medical Device (SaMD).
The International Medical Device Regulatory Forum (IMDRF) defines Software as a Medical Device as “software intended to be used for one or more medical purposes that perform these purposes without being part of a hardware medical device.” This IMDRF definition, recognized by the FDA, includes the following clarifying details:
- SaMD is a medical device and includes in-vitro diagnostic (IVD) medical devices.
- SaMD is capable of running on general purpose (non-medical purpose) computing platforms.
- “Without being part of” means software not necessary for a hardware medical device to achieve its intended medical purpose.
- Software does not meet the definition of SaMD if its intended purpose is to drive a hardware medical device.
- SaMD may be used in combination (e.g., as a module) with other products including medical devices.
- SaMD may be interfaced with other medical devices, including hardware medical devices and other SaMD software, as well as general purpose software.
- Mobile apps that meet the definition above are considered SaMD.
SaMD has grown to be one of the hottest topics in medical devices over the last decade, with Google Trends reporting that search interest in the U.S. reached an all-time high in 2023.
Despite the rising awareness of and interest in SaMD among stakeholders in the medical device industry, and the many options currently available to patients and providers, we know of no list that catalogs all FDA-cleared SaMD out on the market to date.
The closest we have seen so far is the FDA Center for Devices and Radiological Health’s effort to document the number of devices they have cleared that utilize AI/Machine Learning (ML). This list was a useful starting point for our own efforts, but not every item on CDRH’s AI/ML list fits the criteria of SaMD. Though many SaMD utilize AI/ML, by definition SaMD do not have to include such algorithms. Likewise, there are many medical devices on the market which use AI/ML but do not qualify as SaMD due to the AI/ML algorithms being part of a larger system that includes physical or hardware-based components.
Brian and I anticipated that crafting our own FDA-cleared SaMD list from scratch would be a major endeavor. We were pleasantly surprised when Brian quickly discovered that our task was far less challenging than we had imagined.
Brian and I searched publicly available FDA databases to create the current version of our list of FDA-cleared SaMD on the market, found here: List of 483 FDA-Cleared Software as a Medical Device (SaMD). First, we pruned down the aforementioned AI/ML device list to only include devices that met our criteria of SaMD as defined by the IMDRF. We then added in data from exports of device data from 2022 and 2023 data, sourced from the FDA’s archive page for premarket submissions. Finally, we sourced pre-2022 FDA data by using queries and exports from Basil Systems, a commercial Software-as-a-Service vendor offering enhanced access to the FDA’s publicly available medical device datasets through a proprietary interface and a suite of value-added enhancements and harmonizations to the FDA’s published device data.
Our methodology for identifying SaMD in these datasets was to look for all devices whose “PHYSICAL STATES” [sic] related to stand-alone software, software device or software application. Devices with identified “PHYSICAL STATES” of stand-alone software were then combined to produce a list of associated product codes. We then used those product codes to look across Sother databases of AI/ML products as well as Basil Systems’s regulatory search to find stand-alone software and SaMD that we may have missed.
The list that came out of this process was extensive, and now includes 483 devices. However, we are not certain that the data in the FDA databases could possibly include false positives (i.e., devices that are incorrectly classified and do, in fact, include a physical component.) Likewise, it is possible that there are SaMD out on the market that are not classified in the databases we searched under the criteria we described above and need to be added to our list.
Thus, we’d like your help to further refine our list!
How You Can Help
With your help, we’ll have a list that fills a noticeable information gap with accurate data, valuable to anyone looking to improve patient outcomes faster by accelerating the development of SaMD.
About the Authors
Randy Horton, Chief Solutions Officer, Orthogonal
Randy Horton is Chief Solutions Officer at Orthogonal, a software consulting firm that improves patient outcomes faster by helping MedTech firms accelerate their development pipelines for Software as a Medical Device (SaMD), digital therapeutics (DTx) and connected medical device systems. Orthogonal makes that acceleration happen by fusing modern software engineering and product management tools and techniques (e.g., Agile, Lean Startup, User-Centered Design and Systems Thinking) with the regulated focus on device safety and effectiveness that is at the heart of MedTech.
Horton serves as Co-Chair for AAMI’s Cloud Computing Working Group, as well as AAMI CR:510(2021) and the in-process Technical Information Report #115, all of which address how to safely move medical device computing functions into the cloud. He is a frequent speaker at conferences and webinars, including events hosted by AdvaMed, AAMI, HLTH, RAPS and the Human Factors and Ergonomics Society (HFES).
Brian Binkowski has over 10 years of medical device quality experience working for companies such as Boston Scientific, Medtronic, and DTx startup Twill. Brian is an accomplished and impressive “friend of Orthogonal.” He shares our belief that the MedTech industry can rapidly improve patient outcomes by adopting fast feedback loop techniques to the development and enhancement of Software as a Medical Device (SaMD), DTx and connected medical device systems.