ARTICLE;
ARTIFICIAL INTELLIGENCE;
CLINICAL EFFECTIVENESS;
CLINICAL PRACTICE;
DATA ANALYSIS SOFTWARE;
DATA SCIENCE;
DEVICE SAFETY;
FOOD AND DRUG ADMINISTRATION;
HEALTH PROGRAM;
HUMAN;
LEARNING ALGORITHM;
MARKETING;
PATIENT SAFETY;
PUBLIC-PRIVATE PARTNERSHIP;
SOFTWARE DESIGN;
DEVICE APPROVAL;
POSTMARKETING SURVEILLANCE;
SOFTWARE;
STANDARDS;
UNITED STATES;
ARTIFICIAL INTELLIGENCE;
DEVICE APPROVAL;
HUMANS;
PATIENT SAFETY;
PRODUCT SURVEILLANCE, POSTMARKETING;
SOFTWARE;
UNITED STATES;
UNITED STATES FOOD AND DRUG ADMINISTRATION;
Drug Administration. Classify your medical device. Available at: Accessed September 21.
US Food and Drug Administration. Classify your medical device. Available at: https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/ClassifyYourDevice/. Accessed September 21, 2018.
Drug Administration. Evaluation of automatic class III designation (de novo) summaries. Available at: Accessed September 21.
US Food and Drug Administration. Evaluation of automatic class III designation (de novo) summaries. Available at: https://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDRH/CDRHTransparency/ucm232269.htm. Accessed September 21, 2018.
Drug Administration. Software as a medical device (SaMD). Available at: Accessed September 21.
US Food and Drug Administration. Software as a medical device (SaMD). Available at: https://www.fda.gov/MedicalDevices/DigitalHealth/SoftwareasaMedicalDevice/default.htm. Accessed September 21, 2018.
Drug Administration. International Medical Device Regulators Forum (IMDRF). Available at: Accessed September 21.
US Food and Drug Administration. International Medical Device Regulators Forum (IMDRF). Available at: https://www.fda.gov/MedicalDevices/InternationalPrograms/IMDRF/default.htm. Accessed September 21, 2018.
Drug Administration. Medical Device Development Tools (MDDT). Available at: Accessed September 21.
US Food and Drug Administration. Medical Device Development Tools (MDDT). Available at: https://www.fda.gov/MedicalDevices/ScienceandResearch/MedicalDeviceDevelopmentToolsMDDT. Accessed September 21, 2018.
Drug Administration, Center for Devices and Radiological Health. Qualification of medical device development tools: guidance for industry, tool developers, and Food and Drug Administration staff. Available at: Accessed September 21.
US Food and Drug Administration, Center for Devices and Radiological Health. Qualification of medical device development tools: guidance for industry, tool developers, and Food and Drug Administration staff. Available at: https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM374432.pdf. Accessed September 21, 2018.
Drug Administration. National Evaluation System for Health Technology (NEST). Available at: Accessed September 21.
US Food and Drug Administration. National Evaluation System for Health Technology (NEST). Available at: https://www.fda.gov/aboutfda/centersoffices/officeofmedicalproductsandtobacco/cdrh/cdrhreports/ucm301912.htm. Accessed September 21, 2018.
Demonstration projects. Available at: Accessed September 21.
National Evaluation System for Health Technology Coordinating Center. Demonstration projects. Available at: https://nestcc.org/demonstration-projects/. Accessed September 21, 2018.
FDA-funded NEST program names ACR Data Science Institute AI use case as demonstration project. Available at: Accessed September 21.
American College of Radiology. FDA-funded NEST program names ACR Data Science Institute AI use case as demonstration project. Available at: https://www.acr.org/Media-Center/ACR-News-Releases/2018/FDA-NEST-Program-Names-ACR-DSI-Use-Case-as-Demo-Project. Accessed September 21, 2018.
Drug Administration. Digital Health Software Precertification (Pre-Cert) Program. Available at: Accessed September 21.
US Food and Drug Administration. Digital Health Software Precertification (Pre-Cert) Program. Available at: https://www.fda.gov/MedicalDevices/DigitalHealth/DigitalHealthPreCertProgram/default.htm. Accessed September 21, 2018.
Drug Administration. Computer-assisted detection devices applied to radiology images and radiology device data—premarket notification [510(k)] submissions—guidance for industry and Food and Drug Administration staff. Available at: Accessed September 21.
US Food and Drug Administration. Computer-assisted detection devices applied to radiology images and radiology device data—premarket notification [510(k)] submissions—guidance for industry and Food and Drug Administration staff. Available at: https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm187249.htm. Accessed September 21, 2018.
Drug Administration. Letter from Robert Ochs to Robert Tomek. Available at: Accessed September 21.
US Food and Drug Administration. Letter from Robert Ochs to Robert Tomek. Available at: https://www.accessdata.fda.gov/cdrh_docs/pdf17/DEN170022.pdf. Accessed September 21, 2018.
