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Compliance Corner: Review Risks When Making Product Or Process Changes, FDA Official Warns

 
• By Shawn M. Schmitt

The US FDA compliance officer says medtech manufacturers would be wise to evaluate changes to stay out of hot water with the agency.

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An official with the US Food and Drug Administration is reminding medtech companies that changes they make to medical devices or how they’re made should be closely evaluated to make sure finished products aren’t adversely impacted.

During FDA facility inspections, investigators “often see problems arise when change occurs, and historically, we know that seemingly trivial changes...

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