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Industry Says Update To 510(k) Modification Policy Should Emphasize Design Controls, Risk Management

As FDA prepares a report due to Congress in January on its policy for determining when a modified device needs a new 510(k), industry representatives say major changes are not necessary to the current process. But they suggest some tweaks that could make things work more smoothly.

FDA’s current policy for determining when a modified device needs a new 510(k) works well without major changes, device industry representatives say. But they say it could be improved with more emphasis on the importance of design controls and risk management procedures to guide a company’s decision-making process.

FDA held a public meeting June 13 at its Silver Spring, Md., headquarters to gather stakeholder input on its 510(k)...

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