FDA Spells Out When Medical Device Modifications Need Review

2017-10-26 20:18

Agency Clarifies When Manufacturers Need FDA Approval for Security ChangesTrying once again to clarify that security patches to medical devices usually don't need regulatory approval, the Food and Drug Administration has issued final guidance clarifying exactly when manufacturers must have the agency review device modifications.

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https://www.inforisktoday.com/fda-spells-out-when-medical-device-modifications-need-review-a-10412

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