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Merge pull request #104 from DIDSR/dev
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Add glossary. PCCP guidance is draft.
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brandon-gallas authored Oct 8, 2024
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5 changes: 3 additions & 2 deletions assets/pages/infoMedicalImagingAIregulatorySubmissions.md
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Expand Up @@ -187,8 +187,9 @@ The Premarket Approval **(PMA)** regulatory pathway is for medical devices that

* [Guidance document: Off-the-Shelf Software Use in Medical Devices.](https://www.fda.gov/regulatory-information/search-fda-guidance-documents/shelf-software-use-medical-devices)

* [Machine Learning-enabled Medical Devices: Key Terms and Definitions](https://www.imdrf.org/documents/machine-learning-enabled-medical-devices-key-terms-and-definitions)
* [FDA Digital Health and Artificial Intelligence Glossary – Educational Resource](https://www.fda.gov/science-research/artificial-intelligence-and-medical-products/fda-digital-health-and-artificial-intelligence-glossary-educational-resource)

* [Machine Learning-enabled Medical Devices: Key Terms and Definitions](https://www.imdrf.org/documents/machine-learning-enabled-medical-devices-key-terms-and-definitions)

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* [Webpage: Artificial Intelligence and Machine Learning in Software as a Medical Device.](https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-and-machine-learning-software-medical-device)

* [Guidance document: PCCP.](https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial)
* [DRAFT Guidance document: PCCP.](https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial)


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4 changes: 2 additions & 2 deletions assets/pages/presentations.md
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Expand Up @@ -6,7 +6,7 @@ title: HTT Presentations
## Full Library of Work from the HTT Team

[HTT Zotero library](https://www.zotero.org/groups/4384613/eedap_studies_presentations_publications_and_studies/library)
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[HTT Publications](./publications.md)

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Brandon D. Gallas, “Regulatory Pathways and Science Related to Digital and Computational Pathology,” presented at the The Jean-Oliver Redmond President’s Symposium 2024, New York Pathological Society (NYPS), New York, NY, 2024
[View or download the slides here](./zotero-pdfs/Gallas-NYPS-2024.pdf)

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Brandon D. Gallas, “Collecting and Annotating Digital Pathology Images to Assess Computational Pathology,” presented at the United States and Canadian Academy of Pathology, Baltimore, MD, Mar. 25, 2024.
[View or download the slides here](./zotero-pdfs/Gallas-USCAP-2024.pdf)
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