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FDA Treatment of AI, Machine Learning Software as a Medical Devic

FDA Treatment of AI, Machine Learning Software as a Medical Devic
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Rob califfDigital health centerUs congressSoftware precertification pilot programNational evaluation systemDrug administrationMachine learningMedical devices workshopCurrent medical deviceFederal foodCosmetic actDifferent regulatory pathwayWithout legislation authorizingNew regulatory

FDA Needs a New Approach to AI/ML-Enabled Medical Devices | Mintz - Health Care Viewpoints

We have been writing about software as a medical device (SaMD) for years, tracking the Food and Drug Administration's (FDA) efforts to keep up with the fast-paced development of digital.

Rob califfDigital health centerHealth care viewpointsUs congressNational evaluation systemDrug administrationSoftware precertification pilot programMachine learningMedical devices workshopCurrent medical deviceFederal foodCosmetic actDifferent regulatory pathwayWithout legislation authorizingNew regulatory

The U.S. Food and Drug Administration (FDA) will schedule a public meeting of the Medical Devices Advisory Committee later this year to discuss study results, real-world data, and other.

Michael sjodingHealth care viewpointsDrug administrationDevices advisory committeeMedical devices advisory committeeMedical devices workshopNew england journalDiversity plansImprove enrollmentParticipants from underrepresented racialEthnic populationsClinical trialsClinical trial populationsEligibility criteriaEnrollment practicesTrial designs

FDA Audits Pulse Oximeter Efficacy To Address Digital Health Bias

Food and Drug Administration FDA to schedule public meeting of Medical Devices Advisory Committee to discuss study results about pulse oximeter performance. Meeting consistent with agency efforts to evaluate clinical trial design transparency, diversity, AI development need.

Michael sjodingDrug administrationDevices advisory committeeMedical devices advisory committeeMedical devices workshopNew england journalDiversity plansImprove enrollmentParticipants from underrepresented racialEthnic populationsClinical trialsClinical trial populationsEligibility criteriaEnrollment practicesTrial designsFood and drug administration

FDA Audits Pulse Oximeter Efficacy To Address Digital Health Bias

FDA Audits Pulse Oximeter Efficacy To Address Digital Health Bias
natlawreview.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from natlawreview.com Daily Mail and Mail on Sunday newspapers.

Michael sjodingDrug administrationDevices advisory committeeMedical devices advisory committeeMedical devices workshopNew england journalDiversity plansImprove enrollmentParticipants from underrepresented racialEthnic populationsClinical trialsClinical trial populationsEligibility criteriaEnrollment practicesTrial designs