FDA Warning Letter Recap, March 2021: Unapproved COVID-19 Products Lead To Surge In Enforcement Letters
The US FDA handed out 15 warning letters in March to manufacturers of various products that were unapproved to mitigate or prevent COVID-19. Meanwhile, a 16th letter – the output of a 2019 facility inspection by the agency – led to quality system violations for a maker of wound dressings. The device-related letters are the first posted online by the FDA since December 2020.
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Becton Dickinson’s CareFusion 303 Inc. subsidiary recalled 145,492 of the pumps because there’s a risk that the device’s keypad will lift up and away from the device body if it comes into contact with fluids.
Top US FDA device center officials Jeff Shuren and William Maisel said in a 15 April blog post that manufacturers should expect a delay in the review of new product submissions thanks to the pandemic. They noted that the agency also won’t be accepting certain IVD pre-submission requests until next year.
12 Deaths Prompt Another Class I Recall For Medtronic’s HeartWare – The Firm’s Fourth In Recent Weeks
The medtech giant has racked up yet another high-risk class I recall designation from the US FDA, this time for HeartWare Ventricular Assist Device (HVAD) cables and controller ports. It’s also the second class I recall action for the HeartWare device in a little more than six weeks, and the company’s fourth overall.