FDA information on computer assisted (CAD) technologies

FDA information on computer assisted (CAD) technologies

*****NOT-ACTIVE (dead links) FDA's guidances on CAD systems*****
These guidances were deleted from FDA somewhere in 2017.
1) Guidance for Industry and FDA Staff - Clinical Performance Assessment: Considerations for Computer-Assisted Detection Devices Applied to Radiology Images and Radiology Device Data - Premarket Approval (PMA) and Premarket Notification [510(k)] Submissions
URL: https://web.archive.org/web/20161028224500/http://www.fda.gov/RegulatoryInformation/Guidances/ucm187277.htm
PDF: https://web.archive.org/web/20161022010001/http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm187315.pdf

2) Guidance for Industry and Food and Drug Administration Staff - Computer-Assisted Detection Devices Applied to Radiology Images and Radiology Device Data - Premarket Notification [510(k)] Submissions
URL: https://web.archive.org/web/20170118091545/http://www.fda.gov/RegulatoryInformation/Guidances/ucm187249.htm
PDF: https://web.archive.org/web/20170111012408/http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm187294.pdf

*****GOOGLE SEARCH STRATEGY*****
Search string for 510(k):
("neural networks" OR "machine learning" OR "artificial intelligence" OR "computer assisted" OR "computer assistance") AND "and have determined the device is substantially equivalent" +filetye:pdf +site:fda.gov

Search string for PMA approvals:
("neural networks" OR "machine learning" OR "artificial intelligence" OR "computer assisted" OR "computer assistance") AND ("pleased to inform you that the PMA is approved" OR "PMA supplement is approved") +filetye:pdf +site:fda.gov

Search string for De Novo approvals:
("neural networks" OR "machine learning" OR "artificial intelligence" OR "computer assisted" OR "computer assistance") AND ("under the generic name") +filetye:pdf +site:fda.gov