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Warning Letter Roundup & Recap

Warning Letter Roundup & Recap – Jan. 9, 2018

US FDA did not release any device-related warning letters the week of Jan. 9.

Device Warning Letters FDA

Warning Letter Close-Outs – December 2017

US FDA did not release any device-related close-out letters in December.

Device Warning Letters FDA

Warning Letter Roundup & Recap – Jan. 2, 2018

US FDA did not release any device-related warning letters the week of Jan. 2

Device Warning Letters FDA

Warning Letter Roundup & Recap – Dec. 26, 2017

US FDA outlines a bevy of quality systems and Medical Device Reporting violations in a lengthy warning letter to TELEMED. It was one of two device-related letters posted this week.

Device Warning Letters FDA

Warning Letter Roundup & Recap – Dec. 19, 2017

US FDA asks syringe-maker Nurse Assist to hire a consultant to audit its manufacturing and quality systems, and targets another firm for marketing Zika virus tests without pre-market approval or clearance in two device-related warning letters posted this week.

Device Warning Letters Regulation

Warning Letter Roundup & Recap – Dec. 12, 2017

US FDA did not release any device-related warning letters the week of Dec. 12

Medical Device Device Warning Letters

Warning Letter Roundup & Recap – Dec. 5, 2017

US FDA addressed quality systems and Medical Device Reporting violations at a manufacturer of bone fixation fastener systems in the only device-related warning letter posted this week.

Device Warning Letters Regulation

Warning Letter Close-Outs – November 2017

US FDA released seven device-related close-out letters in November.

Device Warning Letters Regulation

Warning Letter Roundup & Recap – Nov. 28, 2017

US FDA did not release any device-related warning letters the week of Nov. 28.

Device Warning Letters Regulation

Warning Letter Roundup & Recap – Nov. 21, 2017

US FDA did not release any device-related warning letters the week of Nov. 21.

Device Warning Letters Regulation

Warning Letter Roundup & Recap – Nov. 14, 2017

US FDA addressed quality systems and recall violations at the Florida maker of ProSun SunDream tanning beds in the only device-related warning letter posted this week.

Device Warning Letters Regulation

Warning Letter Roundup & Recap – Nov. 7, 2017

US FDA did not release any device-related warning letters the week of Nov. 7.

Device Warning Letters Regulation
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