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Warning Letter Roundup & Recap

Warning Letter Roundup & Recap – May 17, 2018

German maker of the Twion Power Push-Rim Power Drive System cited for quality systems violations; RADLogics was marketing its AlphaPoint software without pre-market approval or clearance from US FDA.

Device Warning Letters FDA

Warning Letter Roundup & Recap – May 8, 2018

US FDA did not release any device-related warning letters the week of May 8.

Device Warning Letters FDA

Warning Letter Close-Outs – April 2018

US FDA released one device-related close-out letter in March.

Device Warning Letters FDA

Warning Letter Roundup & Recap – May 1, 2018

US FDA did not release any device-related warning letters the week of May 1.

Device Warning Letters FDA

Warning Letter Roundup & Recap – April 24, 2018

US FDA did not release any device-related warning letters the week of April 24.

Device Warning Letters FDA

Warning Letter Roundup & Recap – April 17, 2018

Medical Device Reporting violations noted at maker of the SynCardia Temporary Total Artificial Heart System in the only device-related warning letter released by US FDA this week.

Device Warning Letters FDA

Warning Letter Roundup & Recap – April 10, 2018

US FDA did not release any device-related warning letters the week of April 10.

Device Warning Letters FDA

Warning Letter Close-Outs – March 2018

US FDA released one device-related close-out letter in March.

Device Warning Letters FDA

Warning Letter Roundup & Recap – April 3, 2018

US FDA did not release any device-related warning letters the week of April 3.
Medical Device Device Warning Letters

Warning Letter Roundup & Recap – March 27, 2018

US FDA did not release any device-related warning letters the week of March 27.

Device Warning Letters FDA

Warning Letter Roundup & Recap – March 20, 2018

In the only device-related warning letter released by US FDA this week, a specification developer of orthopedic implants was cited for quality systems violations.

Device Warning Letters FDA

Warning Letter Roundup & Recap – March 13, 2018

Duodenoscope-makers Olympus, Fujifilm and Pentax Medical failed to conduct post-market surveillance study activities mandated by US FDA in 2015; quality systems violations noted at firms that make dental diagnostic X-ray devices and laser fiber-optic surgical devices. Six device-related warning letters were released by the agency this week.

Device Warning Letters FDA
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