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Device Advice for AI and Machine Learning Algorithms In Medical Imaging

Here is a document of links pointing to FDA guidance documents and other forms of communication. It was compiled by googling CDRH regulatory buzz words. We hope this document is useful. You might also refer to Figure 2 of this paper: Marble et al. (2020). A regulatory science initiative …” J Pathol Info, 11(1), 22.

Caveat to all: You won’t know what’s required for your submission until you ask in a Q-sub.

Pre-submission meeting

In CDRH, the best advice is to know about pre-submission meetings.

IFU: Indications for Use

Part of the definition of your medical device are the indications for use.

It’s never to early to start thinking about, researching, and crafting an IFU for your device.

Comprehensive Regulatory Assistance

510k program

A Premarket Notification, 510(k), is a submission made to FDA to demonstrate that the device to be marketed is safe and effective by proving substantial equivalence (SE) to a legally marketed device (predicate device).

de Novos

  • Special controls accompany all de Novo classifications.
  • Special controls outline submission requirements for medical devices with similar IFU.
  • Special controls are defined for a device type that can be broad or narrow.

If you can’t find a de Novo or existing 510k that is a perfect predicate for your device type: Then find and learn about the closest one or two. It’s a way to start.


Pursuing a pre-market authorization (PMA) is a regulatory pathway for medical devices that have a higher risk profile than a 510(k). PMAs are not covered here but information can be found by searching for “FDA CDRH PMA” from any internet search engine.

Software as a Medical Device (SAMD)

Quantitative Imaging

Guidance Technical Performance Assessment of Quantitative Imaging in Device Premarket Submissions

Adaptive Algorithms, continuous learning

Digital Pathology

CAD Examples

Presentations in this space

  • “Tutorial on Reader Study Designs and MRMC Analysis”
    • FDA internal training, April 8, 2022, Silver Spring
    • Brandon Gallas, Research Mathematical Statistician, Division of Imaging, Diagnostics, and Software Reliability OSEL, CDRH, FDA
    • DRH_Reader_Study_Tutorial_-_MRMCstudyDesigns-20220408.pdf (3 MB, uploaded by Brandon D. Gallas 3 weeks ago)
  • “Regulatory Considerations and Assessment of AI/ML Devices”
  • “AI and Digital Pathology: Regulatory Perspective”
    • Pathology Visions, October 8, 2019, Orlando, FL.
    • Shyam Kalavar, Senior Scientific Reviewer, Division of Molecular Genetics and Pathology
    • S.Kalavar.PathVision2019.pdf (2 MB, uploaded by Brandon D. Gallas 2 years 6 months ago)
  • “Evaluating Artificial Intelligence Devices at the FDA and Related Collaborations and Initiatives”
    • ACR Informatics Summit, October 5-6, 2019, Washington, DC.
    • Brandon Gallas, PhD, Research Mathematical Statistician, Division of Imaging, Diagnostics, and Software Reliability OSEL, CDRH, FDA
    • 20191005ACRinformaticsSummit_BDG-6-FINAL.pdf (5 MB, uploaded by Brandon D. Gallas 2 years 7 months ago)
    • Jennifer Segui, Lead Medical Device Reviewer, Division of Radiological Health, FDA
    • J.A.Segui.ACR.Informatics.2019.Slides.FINAL.pdf (3 MB, uploaded by Brandon D. Gallas 2 years 7 months ago)
  • “Evaluation and Regulatory Considerations for AI Methods in Medical Imaging”
  • “Digital Pathology Regulatory Considerations”

Medical Device Development Tools (MDDT) program

The FDA’s Medical Device Development Tools (MDDT) program is a way for the FDA to qualify tools that medical device sponsors can use in the development and evaluation of medical devices. It is a way for the broader community (academia, health providers, and government scientists, not just industry) can impact the regulatory process.

Catalog of Regulatory Science Tools to Help Assess New Medical Devices

Mock Submission

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