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Warning Letter Roundup & Recap

Warning Letter Roundup & Recap – 22 October 2019

No device-related warning letters were released by the US FDA the week of 22 October.

Device Warning Letters FDA

Warning Letter Roundup & Recap – 15 October 2019

In the only device-related warning letter released by the US FDA this week, a manufacturer of a dental X-ray sensor and X-ray system was cited for quality systems violations. The firm also failed to notify the agency of accidental radiation occurrences.

Device Warning Letters FDA

Warning Letter Roundup & Recap – 8 October 2019

No device-related warning letters were released by the US FDA the week of 8 October.

Device Warning Letters FDA

Warning Letter Close-Outs – September 2019

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

Device Warning Letters FDA

Warning Letter Roundup & Recap – 1 October 2019

No device-related warning letters were released by the US FDA the week of 1 October.

Device Warning Letters FDA

Warning Letter Roundup & Recap – 24 September 2019

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

Device Warning Letters FDA

Warning Letter Roundup & Recap – 17 September 2019

In the only device-related warning letter released by the US FDA this week, the maker of Bounder wheelchairs was cited for premarket and Medical Device Reporting violations.

Device Warning Letters FDA

Warning Letter Roundup & Recap – 10 September 2019

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

Device Warning Letters FDA

Warning Letter Roundup & Recap – 3 September 2019

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

Device Warning Letters FDA

Warning Letter Close-Outs – August 2019

The US FDA released four device-related close-out letters in August.

Device Warning Letters FDA

Warning Letter Roundup & Recap – 27 August 2019

No device-related warning letters were released by the US FDA the week of 27 August.

Device Warning Letters FDA

Warning Letter Roundup & Recap – 21 August 2019

A maker of in vitro diagnostics was dinged for premarket, quality systems, Medical Device Reporting and corrections & removals violations. It's just one of two device-related warning letters released by the US FDA this week.

Device Warning Letters FDA
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