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Warning Letter Roundup & Recap

Warning Letter Roundup & Recap – Feb. 21, 2017

No device-related warning letters were released by US FDA the week of Feb. 21.

Device Warning Letters Regulation

Warning Letter Roundup & Recap – Feb. 14, 2017

Refusing a US FDA inspection brought a warning letter to a Chinese maker of surgical gear; quality systems violations noted at a blood glucose test meter company; a California-based marketer of diagnostic equipment marketed an unapproved device. FDA issued three device-related warning letters the week of Feb. 14.

Medical Device Device Warning Letters

Warning Letter Roundup & Recap – Feb. 7, 2017

Three device-related warning letters were issued by the agency the week of Feb. 7, including a missive to Taiwan-based glucose monitor firm HMD Biomedical highlighting device design, process control and environmental control lapses.

Medical Device Device Warning Letters

Warning Letter Close-Outs – January 2017

US FDA released two device-related close-out letters in January.

Device Warning Letters Policy & Regulation

Warning Letter Roundup & Recap – Jan. 31, 2017

Quality systems and Medical Device Reporting violations found at German cardiac device company Biotronik; two firms receive warnings after they marketed devices without US FDA approval. Seven warning letters were issued by the agency the week of Jan. 31.

Device Warning Letters Medical Device

Warning Letter Roundup & Recap – Jan. 24, 2017

No device-related warning letters were released by US FDA the week of Jan. 24.

Device Warning Letters Regulation

Warning Letter Roundup & Recap – Jan. 17, 2017

No device-related warning letters were released by US FDA the week of Jan. 17.

Device Warning Letters Policy & Regulation

Warning Letter Roundup & Recap – Jan. 10, 2017

No device-related warning letters were released by US FDA the week of Jan. 10.

Device Warning Letters Medical Device

Warning Letter Close-Outs – December 2016

US FDA released five device-related close-out letters in December.

Device Warning Letters Policy & Regulation

Warning Letter Roundup & Recap – Jan. 3, 2017

No device-related warning letters were released by US FDA the week of Jan. 3.

Device Warning Letters Policy & Regulation

Warning Letter Roundup & Recap – Dec. 27, 2016

Quality systems problems found at manufacturer/repacker of contact lens cases and other products in the only device-related warning letter released by US FDA this week.

Device Warning Letters Policy & Regulation

Warning Letter Roundup & Recap – Dec. 20, 2016

US FDA finds quality systems and Medical Device Reporting violations at Zyno Medical in the only device-related warning letter released by the agency this week.

Device Warning Letters Policy & Regulation
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