FDA Updates the Regulatory Definitions of Certain Software Types for Consistency with 21st Century Cures Act Exclusions

By McKenzie E. Cato

The 21st Century Cures Act (“Cures Act”), which was enacted in 2016 (see our blog post here), excluded from the statutory definition of “device” five categories of software:

  1. Software for administrative support of a health care facility;
  2. Software for maintaining or encouraging a healthy lifestyle and is unrelated to the diagnosis, cure, mitigation, prevention, or treatment of a disease or condition (so-called “general wellness” software);
  3. Electronic medical record software;
  4. Certain types of medical device data system (MDDS) software, which is software intended to transfer, store, convert formats, or display device data; and
  5. Certain types of clinical decision-support software.

To date, FDA had not updated its classification regulations, the FDA regulations defining categories of devices and outlining the applicable regulatory controls, to carve out the categories of software devices excluded from the device definition by the Cures Act.  This lag was, at times, a source of confusion when attempting to determine whether a new software functionality was subject to regulation as a device and required 510(k) clearance.

On April 19, FDA published a final rule amending eight classification regulations to exclude software functions that no longer fall within the device definition:

Classification Regulation

(21 C.F.R.)

Device Type Modification
862.2100 Calculator/Data Processing Module for Clinical Use Remove non-device software functions to maintain and retrieve laboratory data
862.1350 Continuous Glucose Monitor (CGM) Secondary Display Remove software functions regarding receipt and display of data, and amend the title of the regulation to “Continuous Glucose Monitor (CGM) Secondary Alarm System”
866.4750 Automated Indirect Immunofluorescence Microscope and Software-Assisted System Replace “software” with “device” in the device category name, because both hardware and software functions that use fluorescent signal acquisition and processing software, data storage, and transferring mechanisms, or assay specific algorithms to interpret or analyze results, are devices
880.6310 Medical Device Data System Remove non-device software functions intended for transferring, storing, converting formats, or displaying clinical laboratory test or other device data and results
884.2730 Home Uterine Activity Monitor Remove non-device software functions intended for transmitting, receiving, and displaying data
892.2010 Medical Image Storage Device Remove non-device software functions intended for storing and retrieving, so that a medical image storage device is a hardware device that provides electronic storage and retrieval functions for medical images
892.2020 Medical Image Communications Device Include software functions intended for medical image processing and manipulation
892.2050 Picture Archiving and Communications System Remove non-device software functions intended for storing and displaying medical images, clarify that the regulation includes software and hardware functions intended for medical image management and processing, and revise the title of the classification regulation to “Medical Image Management and Processing System”

By removing the non-regulated software functionalities, the classification regulations can more easily be used to identify regulated software functionalities.

The modifications to the Picture Archiving and Communications System (PACS) classification regulation, in particular, are a welcome change.  This category of devices was defined very broadly in the previous classification regulation, and many types of radiological imaging software fell within the PACS definition.  By narrowing down the PACS definition to remove functionalities for storage and display of images, it will be much easier to evaluate the regulatory status of a new radiological imaging software.