FDA issues SOP on premarket data change notifications

09/16/2013 | MassDevice.com (Boston)

The FDA's device center has issued a draft Standard Operating Procedure on how the agency intends to notify manufacturers when new scientific evidence changes data requirements for regulatory applications. The agency is accepting input on the SOP, which would apply to submissions for premarket approval, 510(k) clearance and investigational device exemption.

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MassDevice.com (Boston)

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