Quantitative Imaging

In April 2019, FDA released a draft guidance providing manufacturers and FDA staff with detailed recommendations on assessing the technical performance of quantitative imaging devices and how the documentation from those assessments should be provided in premarket submissions. From a big picture perspective, one should remember the overall goal is to “provide performance specifications for the quantitative imaging functions, supporting performance data to demonstrate that the quantitative imaging functions meet those performance specifications, and sufficient information for the end user to obtain, understand, and interpret the values provided by the quantitative imaging functions.”

The guidance document establishes consistency terminology to be used when describing quantitative imaging functions. We recommend that your documentation use this terminology to best communicate your product to FDA. If your documentation uses other terms, provide a “terminology map” right up front in the submission so that the reviewer will correctly understand your documentation.

The guidance provides a section on potential sources of measurement error that would be very useful for risk management. We would recommend that your hazard analysis activity consider all of the categories from the guidance and use it as a model for further hazard discovery.  One should also review recalls related to similar devices to learn of possible hazards and failure modes.  Our website provides a collection of software related recalls to aid in that activity.  To see a listing of posts related to imaging recalls, just click this link:  https://www.softwarecpr.com/?s=imaging

The guidance emphasizes the need for predefined performance specifications. Like all requirements and specifications, one should consider how an objective evaluation of the requirement or specification will be performed. From a software perspective, we recommend methods to have the software provide additional outputs, not normally provided to an operator, but necessary for proper evaluation. For example, the software might output interim calculations and components of the larger calculation that can be evaluated separately, or perhaps statistical parameters for a set of data. This type of output can help support the argument for software verification required by the guidance.

Download the guidance here: FDA Quantitative Imaging Guidance draft – April 2019

About the author

Brian Pate helps medical device companies achieve efficient and FDA regulatory compliant product development to produce higher quality and clinically valued software. He began his career in clinical research in 1985 with the Department of Anesthesiology at UAB developing closed-loop control systems for the automated delivery of gases and control. In 1990, he made the switch from university research to the medical device industry designing control systems, communication interfaces, user interface, and other software for real-time embedded systems and clinical information systems, working for medical device companies including Johnson & Johnson, Baxter Healthcare, and GE Medical. Today, he is a Partner and the General Manager of Crisis Prevention and Recovery LLC (dba SoftwareCPR®), a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software. He has taught the AAMI/FDA course on Software Regulation to FDA Reviewers at FDA and is currently the lead faculty for the public version of that course taught annually along with FDA staff. Brian served on the AAMI/FDA TIR working group that created AAMI TIR32 Guidance on the application of ISO 14971 to Software (later superseded by IEC 80002-1). He later served on the original AAMI/FDA working group that created the AAMI TIR45-2012 TIR Guidance on the use of Agile practices in the development of medical device software and is currently the co-chair leading the creation of the 2nd edition of TIR45. He has served as faculty for all offerings of the AAMI/FDA Compliant Use of Agile Methods public course. Brian also served as an instructor for the AAMI Design Controls course. He is also a member of the Underwriters’ Laboratories Standards Technical Panel 5500, Remote Software Updates. He now serves as a member of the AAMI Software Committee.

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