Devil Is Always in the Details: FDA Updates Device Classification Regulations To Remove Certain Software Functions

On April 19, 2021, FDA issued a final rule that amends its device classification regulations to exclude from regulation as a medical device certain types of software functions for certain products.

This final rule takes effect immediately. The Federal Register Notice here can be found here.

To fully appreciate the changes made (and not made) in FDA’s updated classification regulations, one must bear in mind that the statutory exclusions apply only to certain software functions. This point is captured in no uncertain terms in FDA’s final rule. Indeed, in the preamble to the final rule – and as evidenced in the revised device classification regulations themselves -- FDA makes clear that device hardware intended to transfer, store, convert formats, and display medical data and results remains a medical device and remains regulated by FDA as such.

Of the software functions excluded from FDA’s device statutory authority, FDA’s final rule focuses primarily on those that are solely intended to transfer, store, convert, or display clinical laboratory test or other device data and results. Notably, this statutory exclusion does not apply to such functions if they are intended to interpret or analyze clinical laboratory tests or other device data, results, and findings.[1]

With that overview in mind, the following is a more detailed description of the changes made to the specific FDA’s device classification regulations.

  • Medical Device Data System (21 C.F.R. 880.6310): revises the “identification” description to limit it to hardware devices and deletes “software” and “communications protocol” from the list of system components. This revised classification regulation also further specifies that it does not include hardware devices intended to be used in connection with active patient monitoring, as they are classified separately.
  • Medical Image Storing Device (21 C.F.R. 892.2010): revises the “identification” description to limit it to hardware devices that provide electronic storage and retrieval functions for medical images.
  • Medical Image Communications Device (21 C.F.R. 892.2020): revises the “identification” description to explicitly retain authority over products with specific software functions for medical image processing and manipulation. 
  • Picture Archiving and Communications System (21 C.F.R. 892.2050): Amends title of this classification to “Medical Management and Processing System.” (Emphasis added.) FDA explains that whereas the prior classification included both software and hardware image storage and display functions, the Cures Act excluded those software functions from the statutory definition of medical device. Notably, however, FDA further explains its view that software functions for complex image processing remain device functions and are thus retained in the revised classification regulation.

In addition to the foregoing, the following miscellaneous classification regulations for other categories of devices are amended in FDA’s final rule:

  • Calculator/Data Processing Module for Clinical Use (21 C.F.R. 862.2100): revises the “identification” description to delete the functions of “storing” and “retrieving” and, instead, to be defined solely in terms of its “processing” function.
  • Continuous Glucose Monitor (CGM) Secondary Display (21 C.F.R. 862.1350): (1) revises the title to replace “Display” with “Alarm System” (because the latter is deemed by FDA to require analysis or interpretation and thus not to be excluded from the statutory definition of device); and (2) revises the definition to describe the intended use as a secondary “alarm” for a CGM “to enable immediate awareness for potential clinical intervention to help assure patient safety.” 
  • Home Uterine Activity Monitor (21 C.F.R. 884.2730): revises the “identification” description to delete software functions intended to transmit, receive, and display data.
  • Automated Indirect Immunofluorescence Microscope and Software-Assisted System (21 C.F.R. 866.4750) revises the “identification” description to replace “software” in the penultimate sentence with “device” so as to retain FDA’s authority over software functions that FDA deems to continue to fall within the device definition (e.g., assay-specific algorithms to suggest results).

[1] This assumes that the software function is not “clinical decision support software” otherwise excluded from the definition of “medical device” per the Cures Act. 21 U.S.C. 360j(o)(1)(E); for a detailed discussion of FDA’s interpretation of “clinical decision support software,” see FDA Draft Guidance.


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