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A Team-based Approach to an Expedited 510(k)

by Bruce Waldon | Mar 25, 2023 | Industry News, Med-Devices, New devices, Product-Innovation, Reg_Information, US-FDA

A Team-Based Approach to an Expedited 510(k) Working together for accelerated product introduction Home About Consumer Regulatory Medical Devices Pharma Biologics Combination Products AI Quality QMSR Central News Enforcement Alerts Innovation Contact Getting an...

FDA Warning Letter to Olympus Medical Systems

by Bruce Waldon | Mar 19, 2023 | FDA Enforcement, FDA Warning letters, Med-Devices, US-FDA

Home About Consumer Regulatory Medical Devices Pharma Biologics Combination Products AI Quality QMSR Central News Enforcement Alerts Innovation Contact Letter addresses several violations of FDA&C Act On March 15, 2023, the Food and Drug Administration (FDA)...

Class I Recall for Intra-Aortic Blood Pumps

by Bruce Waldon | 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...

Urgent Action Required – Baxter LIFE2000 System

by Bruce Waldon | 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...

FDA Approval for Cancer Treatment Aid

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...

FDA Posts Warning Letter to MicroVention Costa Rica 

by Bruce Waldon | 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...
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