FDA explains that whereas the prior classification included both softwareandhardware imagestorageanddisplayfunctions, 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 imageprocessingremain 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.”

Hardware that is intended to transfer, store, convert formats and display medical device data and results remains a device unless it is used solely for transfer, storage or conversion of formats and to display medical device data or results.FDA intends to provide recommendations on Non-Device-MDDS and Device-MDDS functions with respect to how they affect the safety and effectiveness of device function(s) in multiple function device products in a separate guidance.Guidance:Off-the-Shelf Software Uses in Medical DevicesOverview In the revised guidance, which updates the September 1999 guidance, FDA removed the section on “Exemption of Laboratory Information Management Systems,” for Laboratory Information Systems and Laboratory Information Management Systems functions, which includes calculator/data processing modules for clinical use under 21 CFR section 862.2100, intended for administrative support. FDA made this change because FDA no longer regulates software that simply transfers, stores, converts formats or displays clinical laboratory test data and results as a “device.”

The fourth exclusion provided in the Cures Act is software intended:(D) “for transferring, storing, converting formats, or displaying clinical laboratory test or other device data and results, findings by a health care professional with respect to such data and results, general information about such findings, and general background information about such laboratory test or other device,” unless the software “is intended to interpret or analyze clinical laboratory test or other device data, results, and findings.”Category D above appears to include products meeting the definition of either a medical device data system (MDDS) or a laboratory information system (LIS). FDA has previously announced it is exercising enforcement discretion not to regulate MMDS; this provision codifies that position. FDA currently regulates LIS as 510(k)‑exempt Class I devices under 21 C.F.R. § 862.2100, product code NVV. An LIS is “intended to store, retrieve, and process laboratory data.” FDA has continued to apply the quality system regulation (QSR) to these devices.