The US Center for Devices and Radiological Health (CDHR), which is the branch of the FDA (the United States regulatory authority), issued a new Guidance on medical devices that generate images. The guidance includes recommendations mainly for medical equipment manufacturers who create the quantitative imaging devices for diagnostic purposes. An example is a device that could create an image used by an operator to analyze the injury of the person. The main feature of such devices is the ability to provide the details in precise measurements — that means that all images are scalable — so that the operator can understand the size of any object displayed on the image. This is also the main criteria of effectiveness of the device – it should provide reliable data with the accuracy needed to be used for diagnostic purposes.

The scope of FDA guidance on medical device

Quantitative imaging devices are widely spread throughout hospitals and are mostly used for diagnostic purposes. Their key feature is the ability to provide the specialists with the visual information (images) that aids in the specification of certain diagnostic procedures needed to be performed and improves the quality of such decisions to be made. Another important point is that the devices of such type should be used exclusively by trained specialists that can interpret the visual information in the form of images created by the device.

The main goal of the new FDA guidance is to create a framework that would certify that all devices of this type are fit for their functional purpose. That is why the document includes a list of potential measurement errors that could lead to mistakes during the diagnostic procedures. The regulating authority also included a list of main criteria that could influence the accuracy of the outcomes.  For example, the criteria mentioned may include the personal characteristics of the patient (such as physiological ones), the image acquisition, and processing issues.

Points of Attention for Medical Equipment Manufacturers

The new FDA guidance on quantitative imaging devices also includes special premarket submission requirements that are important for medical equipment manufacturers. According to the document, the application for the approval should include the following information:

  • A function description detailed enough for the authority to be able to understand the way the device operates
  • A technical performance assessment including the specifications describing the accuracy of the device to confirm that it could be used for diagnostic purposes. The information should describe the measuring functions and the ways to check their performance.
  • End user instructions which should contain all information necessary for the specialist to be able to operate the device. This part should also include a detailed description of the way the device calculates the measured values to be able to detect possible errors and prevent mistakes.

Guidance summary

The new regulations cover most of the questions related to the submission for premarket approval of quantitative imaging medical devices. The final version of the Guidance would also include the provisions on exemptions and De Novo requests. Currently, the Guidance states that manufacturers shall provide information on the way the device operates and how it will calculate measurements in various images. The main principle specifies that the regulating authority (FDA) should be able to ensure that the medical equipment meets the requirements set for the appropriate type of medical devices including the devices’ accuracy and safety requirements.  

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