FDA Multidata Discontinue Use Letter

FDA issued a letter to Radiation Oncologists, Medical Physicists, Dosimetrists, and Radiation Therapists to discontinue use of devicesfrom Multidata Systems. This company has had a history of issues and has been under consent decree. This letter relates to release of uncleared products. Multidata is the company that was involved in patient deaths in Panama in 2003 which the it was reported that the company claimed it was due to misuse at the time while others asserted risk controls were inadequate.

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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