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 Devices and Pharma | Mar 12, 2023 | Consumer Information, FDA Enforcement, FDA Warning letters, Industry News, Pharmaceuticals, US-FDA
Home About Consumer Regulatory Medical Devices Pharma Biologics Combination Products AI Quality QMSR Central News Enforcement Alerts Innovation Contact Warning Letter Sites Violations of Law In early February of this year, the U.S. Food and Drug Administration (FDA)...
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...