Day

August 12, 2019
Company: Fresenius Kabi Date of Enforcement Report: 8/12/2019 Class I PRODUCT The Volumat MC Agilia Infusion System is an infusion pump used by health care professionals that delivers fluids including medications, blood, and blood products, into a patient’s body in controlled amounts. The pump administers fluids intravenously via an infusion tubing set and is intended...
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What’s New

FDA:  Exemptions, Variances, and Alternate Forms of Adverse Event Reporting for Medical Devices

Manufacturers, importers, and user facilities can request an exemption or variance from any or all of the medical device reporting requirements in 21 CFR Part 803.  Read more:  https://www.fda.gov/medical-devices/medical-device-reporting-mdr-how-report-medical-device-problems/exemptions-variances-and-alternate-forms-adverse-event-reporting-medical-devices

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