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  • nitinhebbar replied to the topic FDA on Recalled Items in the forum Regulatory Basics for Medical Devices 7 years, 8 months ago

    Even Though it’s FDA’s responsibility to test and certify a product safe for clinical use, they are not held responsible for the mistake. The manufacturer are responsible to produce a safe and a reliable product. However, with every recalls, the FDA’s credibility is at stake. Also, with particular recalls, identifying such loopholes pave ways to modify or add new rules and guidelines that will ensure recalls on similar lines are not repeated again.