Warning letters are being issued more frequently by the United States Food and Drug Administration (FDA). Failing to comply with FDA warning letters may lead to severe repercussions such as product seizures, withholding of regulatory approvals/clearances and even civil penalties. Warning letters may also be admitted as evidence in a product liability case. While the FDA’s Quality System Regulations provide a comprehensive and systematic framework for companies to follow during device development, analysis of trends from warning letters issued by the FDA indicates that there are still areas for improvement.
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