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Warning Letter Roundup & Recap

Warning Letter Roundup & Recap – 19 February 2020

No device-related warning letters were released by the US FDA the week of 19 February.

Device Warning Letters FDA

Warning Letter Roundup & Recap – 12 February 2020

No device-related warning letters were released by the US FDA the week of 12 February.

Device Warning Letters FDA

Warning Letter Nosedive: FDA Makes History (Yet Again) By Sending Only 21 Of The Missives To Device Firms In 2019

A mere 21 quality-related warning letters were issued to device makers last year, the US agency tells Medtech Insight. It’s the third year in a row that the FDA has given out a record-low number of letters. In fact, 2019’s count of 21 represents a whopping 83% decrease from just five years ago, when 121 letters were sent to companies.

FDA Device Warning Letters

Warning Letter Roundup & Recap – 4 February 2020

A Korean manufacturer of a compression limb therapy system was cited for quality systems and Medical Device Reporting violations in the only device-related warning letter released by the US FDA this week.

Device Warning Letters FDA

Warning Letter Close-Outs – January 2020

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

Device Warning Letters FDA

Warning Letter Roundup & Recap – 28 January 2020

A maker of multi-parameter patient-monitoring systems was cited for premarket and quality systems violations in the only device-related warning letter released by the US FDA this week.

Device Warning Letters FDA

Warning Letter Roundup & Recap – 21 January 2020

A maker of low-level LED light-therapy devices was cited by the US FDA for premarket, quality systems and Medical Device Reporting violations. It's just one of two device-related warning letters released by the agency this week.

Device Warning Letters FDA

Warning Letter Roundup & Recap – 14 January 2020

No device-related warning letters were released by the US FDA the week of 14 January.

Device Warning Letters FDA

Warning Letter Roundup & Recap – 7 January 2020

No device-related warning letters were released by the US FDA the week of 7 January.

Device Warning Letters FDA

Warning Letter Roundup & Recap – December 2019

The US FDA released two device-related warning letters last month. One was sent to the maker of sterile orthopedic implants; the other to a manufacturer of surgical trays and kits. Both were cited by the agency for quality systems violations.

Device Warning Letters FDA

Warning Letter Close-Outs – December 2019

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

Device Warning Letters FDA

Warning Letter Roundup & Recap – 10 December 2019

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

Device Warning Letters FDA
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