by Devices and Pharma | Mar 18, 2023 | Alerts, Alerts-Device, Class I Recalls, Consumer Safety, Industry News, Med-Devices, Product Recalls, Product Safety, US-FDA
Home About Consumer Regulatory Medical Devices Pharma Biologics Combination Products AI Quality QMSR Central News Enforcement Alerts Innovation Contact Datascope/Getinge IABPs May Malfunction Due to Cable Failure The US Food and Drug Administration (FDA) announced...
by Devices and Pharma | Mar 17, 2023 | Alerts, Alerts-Device, Class I Recalls, Consumer Safety, Med-Devices, Product Recalls, Product Safety, US-FDA
Home About Consumer Regulatory Medical Devices Pharma Biologics Combination Products AI Quality QMSR Central News Enforcement Alerts Innovation Contact Software issue can cause potential harm or death On March 10, the US Food and Drug Administration (FDA) announced...
by David McConkey | Mar 8, 2023 | Consumer Information, FDA Approvals, FDA Public Information, Industry News, Med-Devices, New devices, Product-Innovation, US-FDA
Home About Consumer Regulatory Medical Devices Pharma Biologics Combination Products AI Quality QMSR Central News Enforcement Alerts Innovation Contact The Food and Drug Administration (FDA) on 12 December 2022 announced the approval of Agilent’s Resolution CTDX...
by Devices and Pharma | Mar 1, 2023 | Alerts, FDA Enforcement, FDA Warning letters, Industry News, Med-Devices, US-FDA
Home About Consumer Regulatory Medical Devices Pharma Biologics Combination Products AI Quality QMSR Central News Enforcement Alerts Innovation Contact Identifies several violations of the FD&C Act and QSR On February 7, FDA issued a warning letter it had sent to...
by Devices and Pharma | Mar 1, 2023 | Alerts, Consumer Safety, FDA Public Information, Industry News, Med-Devices, Product Safety, US-FDA
Home About Consumer Regulatory Medical Devices Pharma Biologics Combination Products AI Quality QMSR Central News Enforcement Alerts Innovation Contact Letter outlines risks associated with the heart valve On February 27, the FDA released a letter to healthcare...
by Devices and Pharma | Feb 26, 2023 | Alerts, Alerts-Device, Class I Recalls, Consumer Safety, Industry News, Med-Devices, MedWatch-System, Product Recalls, Product Safety, US-FDA
Home About Consumer Regulatory Medical Devices Pharma Biologics Combination Products AI Quality QMSR Central News Enforcement Alerts Innovation Contact 1200-pound Devices Could Fall on Patients On February 15, the FDA issued a statement announcing a recall of certain...
