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The Food and Drug Administration (FDA or the Agency), the US regulating authority in healthcare products, has published a guidance document dedicated to the technical performance assessment of quantitative imaging in radiological device premarket submissions. The document is intended to provide additional clarifications regarding the applicable regulatory requirements, as well as recommendations to be considered by medical device manufacturers to ensure compliance thereto. In particular, the document outlines the scope of information the authority expects the applicant to provide when applying for marketing approval for a new product to demonstrate compliance with respective regulatory requirements. It is important to mention that provisions of the guidance are non-binding, nor are intended to introduce new rules or impose new requirements the parties involved should follow. Moreover, the authority explicitly states that an alternative approach could be applied, provided such an approach is in line with the respective legislation and has been agreed with the authority in advance. 

Labeling and User Instructions 

The scope of the guidance covers, inter alia, the aspects related to the labeling of medical devices with quantitate image function. As it is stated by the FDA, the information to be submitted by the applicant should contain detailed enough information regarding the labeling compliant with the requirements set forth by regulation 21 CFR part 801. As further explained by the authority, the labeling should include sufficient information for the end-user to obtain, understand, and interpret the values provided by the quantitative imaging function. In particular, the information to be submitted should cover, inter alia, the following aspects: 

• • The measuring and measurement units were used.
  • The algorithms used to process data, as well as restrictions to be considered.
  • Performance specifications address the applicable range of the function. The authority additionally emphasizes that the performance specification or claims in the labeling should correspond to device design requirements or specifications. The document also pays special attention to matters related to uncertainty. 
  • The approach to be followed when assessing the quality and usability of images. In case the initial assessment of images should be performed by the end-user, the labeling should provide detailed enough instructions regarding the way such an assessment should be performed. 
  • Special qualifications and training for end-users will need to be able to use the device safely and efficiently. 
  • If the device is intended to be connected to the database, it is also necessary to provide detailed enough information about the reference database used. In case of a well-known or publicly available database is used, a link could be provided. If the database used is an in-house developed one, the applicant shall provide all the details including its composition. 

Device-Specific Requirements Based on the Type

Apart from labeling requirements, the document also provides explanations of quantitative imaging functions different in terms of input needed from the end-users. The authority mentions that the examples provided are not intended to describe in detail a specific medical device, but just to explain the approach to be followed when assessing the respective matters. The FDA also emphasizes that the appropriate validation and labeling for any particular device will depend on the device’s intended use, the device’s functionality, and the performance claims. 

The first example provided by the FDA describes the device with a manual quantitative imaging function where significant input from end-users is needed. The authority mentions that in such a case the way the product operates should be clear and transparent, while end-users should be able to identify whether the results achieved could be used in the clinical decision-making process. It is also stated that due to the specific nature of a fully-manual quantitative imaging function it cannot be clinically validated in a way ensuring all aspects are addressed. This information should be duly communicated to potential users. As further explained by the FDA, the device description should clearly describe the functionality of the quantitative imaging function, including inputs, outputs, limitations on the patient population, or input images (e.g., imaging modalities, acquisition techniques), while any algorithms implemented by the quantitative imaging function should be specified. 

In the case of a fully-manual quantitative imaging function, the scope of submissions should cover, inter alia, the documentation describing software verification activities. In particular, the documentation should demonstrate that the algorithm operates as intended. 

However, the authority acknowledges the significance of the impact caused by the end-users on the actual performance of medical devices based on this type of function. At the same time, the FDA clearly states that any claims made by the manufacturer concerning the performance of the device should be duly supported by the respective information and data. 

According to the guidance, for this type of product, the labeling should clearly describe the functionality of the quantitative imaging function by addressing labeling elements [described in the guidance], including specifying how the quantitative imaging function calculates output values and providing the geometric formulas employed to generate those results. As was mentioned before, it is important to ensure the information communicated to end-users contains all the details regarding the limitations on input images to be considered to ensure the proper performance of the device. 

The document further outlines the key points related to semi-automated and fully automated quantitative imaging functions. In particular, it describes the approach to be applied concerning function description, technical performance assessment, and labeling (user information). 

In summary, the present FDA guidance addresses specific aspects related to the requirements for medical devices with a quantitative measuring function. The document explains the approach to be followed by medical device manufacturers applying for marketing approval for such products and highlights the most important matters to be taken into consideration in this respect. 

Sources:

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/technical-performance-assessment-quantitative-imaging-radiological-device-premarket-submissions

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