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Warning Letter Close-Outs – April 2022

 
• By Elizabeth Orr

The US FDA issued four close-out letters last month. Three resolved warning letters that had been issued to duodenoscope manufacturers about problems with Sec. 522 postmarket studies.

Resolved Rubber Stamp

Check out Medtech Insight's US FDA Warning Letter Data Tracker here.

This chart lists medical device-related close-out letters posted online by the US Food and Drug Administration in April 2022. The agency's close-out program publicly indicates when a manufacturer has addressed...

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More from Compliance

Don’t Sleep On Inspections: Experts Warn FDA Maintains Enforcement Resources

 
• By Brian Bossetta

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New Guidance From Canada’s HTA Agency On Submission Of AI-Driven Evidence

 
• By Neena Brizmohun

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