Study Finds 28% of FDA-Cleared Devices Since 2005 Contain Software

More than a quarter of the medical devices the U.S. Food and Drug Administration cleared or granted through its 510(k) and De Novo pathways over two decades contain software, and the share has risen in every clinical specialty studied, according to a study published on June 17 in npj Digital Medicine.

The authors, Alexander O. Everhart, Cirrus Foroughi, Melissa Ouellet and Ariel D. Stern, analyzed 47,712 devices authorized from 2005 through 2024 in the eight clinical specialties with the most FDA clearances. They used Nyquist MedTech, a database that makes the FDA's summary documents machine-searchable, to flag devices whose documents included the word "software." A manual review of 400 randomly selected devices found the method was 94% accurate, the paper says.

What the researchers found

Of the 47,712 devices, 13,390, or 28.1%, were digital devices by that measure. Most were hardware with software components: 12,469 devices, 26.1% of the sample, compared with 921, or 1.9%, classified as standalone software as a medical device. The study counted 194 De Novo devices; the rest were 510(k) clearances.

The share of devices with software ranged from 6.5% in orthopedics to 76.5% in radiology. The researchers counted 382 radiology devices with software cleared in 2024, against 168 in 2005, a 227% increase. Clinical chemistry was the exception to the growth trend, with 35 software devices cleared in 2024 compared with 42 in 2005. In 2024, four of the eight specialties had software in more than 40% of their cleared devices, compared with one in 2005.

Few digital devices were new types of technology, the authors found. Only 246 devices, 0.5% of the sample, were both digital and the first cleared device in their product code, and 356, or 0.7%, were the first digital device in a previously analog product code. As of 2024, product codes with digital devices from two or more manufacturers made up roughly 40% of all digital product codes, which the authors said shows the market is not saturated.

A gap in FDA's data

The paper argues that existing FDA databases do not record whether a device has software components, let alone whether it is standalone software or a hardware product with software. The FDA does publish a list of AI-enabled devices; the agency's page for that list says it is not a comprehensive resource and identifies devices primarily by AI-related terms in their authorization documents.

"Regulators will need to develop new and better tools for their colleagues as well as patients, procurement organizations, and providers to track these devices in a systematic way, rather than analyzing individual product descriptions and summary documents (as done in our study)," the authors wrote. They cited prior work finding that digital devices experience more adverse events and recalls than devices without software, and said staffing reductions and reorganizations within the FDA add to the need for timely published data.

The authors noted limitations: devices whose documents did not describe software would be missed, and the study excluded PMA-approved high-risk devices, Humanitarian Device Exemption devices and smaller specialties.