The FDA has amended the classification of medical imaging devices and functions, including PACS.
- The changes enacted by the 21st Century Cure Act have resulted in alteration of the legal definition of “device”
- The eight FDA device reclassifications so far affect image storage devices, picture archiving and communication systems (PACS), and medical image communication devices
- Only medical image storage devices that have electronic storage and retrieval functions will be subjected to FDA device reclassification
- PACS software functions are no longer included in the definition of a medical device
- The FDA regulation regarding PACS has been renamed to Medical Image Management and Processing System (MIMPS)
- The classification of medical image communication devices has been amended to include software functions for medical image processing and manipulation
- The reclassifications are also intended to ease the path of specific device types to market by decreasing the regulatory burdens for approval
The 21st Century Cures Act amended the legal definition of “device” in the Federal Food, Drug, and Cosmetic (FD&C) Act to exclude certain software functions from what constitutes a medical device. In response, the US Food and Drug Administration reclassifications several medical devices and functions to align with the new regulations. This fine-tuning of the classification was also intended to ease the path of specific device types to the market by decreasing the regulatory burden.
What are the changes based on?
The changes initiated by the Cures Act had created confusion for companies operating in the Health IT domain. These companies were eager to know how FDA would regulate applications that it still views as devices.
The FDA has clarified that the new changes exclude those software functions that are intended to store, transfer, or convert formats or displays except if they are used to analyze or interpret clinical lab tests or other device data findings and results.
The changes include functions formerly listed in the definition of a medical device intended for receipt, transmission, or data retrieval because these are termed forms of information transfer. Functions used for data maintenance are also included in the definition because they are related to data storage.
The changes introduced by alteration of the FD&C Act only focus on the software functions to be excluded from the definition of “device.” These changes do not mention hardware functions, which means that device hardware intended to store, transfer, display medical device results and data, and convert formats will still fall under the term “device.”
What do radiologists need to know?
In total, the changes affected the description of eight software functions to make them conform to the provisions given in the Cures Act. However, radiologists and professionals concerned with medical imaging only need to be aware of three reclassifications.
The three reclassifications are related to the following domains:
- Medical image storage devices
- Picture archiving and communication systems (PACS)
- Medical image communication devices
Medical image storage devices
Medical image storage devices perform some functions that are now excluded from the definition of a medical device. In the updated regulations, the FDA clarifies that the functions performed by the hardware could make them fall within the ambit of the department’s regulations.
The FDA medical image storage device identification clause states that: “A medical image storage device is a hardware device that provides electronic storage and retrieval functions for medical images e.g., electronic hardware devices that may employ software, electronic, or electric hardware such as optical discs, magnetic tapes, and digital memory.”
Picture archiving and communication systems (PACS)
One of the highlights of the changes to FDA regulations relates to picture archiving and communication systems (PACS). The software functions associated with the FDA’s PACS classification do not constitute the definition of a medical device anymore.
The FDA has excluded the software functions for the storage and display of medical images from the new description of the regulation.
The FDA has renamed the regulation pertaining to PACS, and now it’s termed as Medical Image Management and Processing System (MIMPS). The renaming is intended to clarify that the current regulation encompasses software elements that offer advanced image processing functions, such as image enhancement, manipulation, or quantification intended to analyze and interpret medical images.
Medical image communication devices
As a result of changes instigated by the Cures Act, the FDA has changed its description of medical image communication devices. The amendments include medical image processing and manipulation software functions. It is worth noting that these functions were always a part of the FDA regulation and have not been excluded under the FD&C act.
According to the updated FDA description, medical image communication devices provide electronic transfer of medical image data between medical devices. These devices can include a physical communication medium, interfaces, and modems. A medical image device may give simple image review software functionality for the processing and manipulation of medical images. Such functionality can include grayscale window and level, zoom and pan, user-delineated geometric compressions, measurements, and user-added image annotations.
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