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Here is a document of links pointing to FDA guidance documents and other forms of communication. It was mostly 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. https://doi.org/10.4103/jpi.jpi_27_20
Caveat to all: You won’t know what’s required for your submission until you ask in a Q-sub.
Pre-submission (Q-sub) 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, also known as a 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).
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Guidance document: Deciding When to Submit a 510(k) for a Change to an Existing Device.
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Guidance document: Deciding When to Submit a 510(k) for a Software Change to an Existing Device.
de Novos
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Special controls accompany all de Novo classifications.
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Special controls outline submission requirements for medical devices with similar IFU.
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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.
PMA
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 in depth.
Software as a Medical Device (SAMD)
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Computer aided detection (CADe) guidance - Radiology
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Guidance document: Off-the-Shelf Software Use in Medical Devices.
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Machine Learning-enabled Medical Devices: Key Terms and Definitions
Quantitative Imaging
Adaptive Algorithms, continuous learning, Predetermined Change Control Plan (PCCP)
Digital Pathology
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Device type: Whole Slide Imaging System
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Phillips IntelliSite Pathology Solution (DEN160056).
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Classification Product Code: PSY
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Record includes special controls.
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Device type: Whole Slide Imaging System
CAD Examples
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Device type: Medical Image Analyzer (including breast cancer detection).
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Secondlook (P010038).
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Originally a PMA. Downclassified to a 510k on 01/22/2020, Federal Register Ruling.
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Classification Product Code: MYN
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Device type: Radiological computer-assisted diagnostic (CADx) software for lesions suspicious for cancer.
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QuantX (DEN170022).
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Classification Product Code: POK
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Device type: Radiological Computer Assisted Detection and Diagnosis Software” (CADe + CADx).
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Imagen OsteoDetect (DEN180005).
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Classification Product Code: QBS
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Device type: Radiological computer aided triage and notification software.
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Viz.AI ContaCT (DEN170073).
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Classification Prodcut Code: QAS
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Device type: Retinal diagnostic software device.
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IDx IDx-DR (DEN180001).
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Classification Prodcut Code: PIB
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Device type: Image Acquisition and/or Optimization Guided by Artificial Intelligence.
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Bay Labs Caption Guidance (DEN190040).
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Classification Product Code: QJU
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Device type: Software Algorithm Device to Assist Users in Digital Pathology
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Paige.AI Paige Prostate (DEN200080).
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Classification Product Code: QPN
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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 Access New Medical Devices
Presentations in this Space
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“Tutorial on Reader Study Designs and MRMC Analysis”
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FDA internal training, April 8, 2022
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Pathology Innovation Collaborative Community Webinar, August 5, 2022
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Brandon Gallas, Research Mathematical Statistician, Division of Imaging, Diagnostics, and Software Reliability OSEL, CDRH, FDA
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Slides: Tutorial on Reader Study Designs and MRMC Analysis by Brandon Gallas
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“ROC curves: Receiver Operating Characteristic Curves”
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FDA internal training, April 8, 2022
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Pathology Innovation Collaborative Community Webinar, August 5, 2022
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Brandon Gallas, Research Mathematical Statistician, Division of Imaging, Diagnostics, and Software Reliability OSEL, CDRH, FDA
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“Regulatory Considerations and Assessment of AI/ML Devices”
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Yale, January 29, 2020, New Haven, Connecticut
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Nicholas Petrick, Deputy Division Director, Division of Imaging, Diagnostics, and Software Reliability OSEL, CDRH, FDA
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Slides: Regulatory Considerations and Assessment of AI by Nicholas Petrick
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“AI and Digital Pathology: Regulatory Perspective”
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Pathology Visions, October 8, 2019, Orlando, FL.
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Shyam Kalavar, Senior Scientific Reviewer, Division of Molecular Genetics and Pathology
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Slides: AI and Digital Pathology Regulatory Perspective by Shyam Kalavar
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“Evaluating Artificial Intelligence Devices at the FDA and Related Collaborations and Initiatives”
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ACR Informatics Summit, October 5-6, 2019, Washington, DC.
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Brandon Gallas, PhD, Research Mathematical Statistician, Division of Imaging, Diagnostics, and Software Reliability OSEL, CDRH, FDA
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Jennifer Segui, Lead Medical Device Reviewer, Division of Radiological Health, FDA
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“Evaluation and Regulatory Considerations for AI Methods in Medical Imaging”
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Society for Imaging Informatics in Medicine Annual Meeting, June 26, 2019, Aurora, Co
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Berkman Sahiner, Senior Scientist, Division of Imaging, Diagnostics, and Software Reliability OSEL, CDRH, FDA
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“Digital Pathology Regulatory Considerations”
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Pathology Informatics Summit 5/9/19
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Cheng Cui, Senior Scientific Reviewer, Division of Molecular Genetics and Pathology,
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Slides: Digital Pathology Regulatory Considerations by Cheng Cui
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Mock Submission
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Webpage: MDICx webinar that includes a presentation on mock submissions to FDA/CDRH.
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Slides: Mock Submissions to FDA/CDRH: History and Lessons Learned by Kyle Myers, Director DIDSR/OSEL/CDRH/FDA. This presentation was made as the agency was working with MDIC to pursue a mock submission about, “Augmenting a Clinical Study with Virtual Patient Models.”
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The mock submission was followed quickly by actual submissions.
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The virtual patients mock submission was preceded by “Protein-Based Multiplex Assays: Mock Presubmissions to the US Food and Drug Administration” , Regnier et al.