Medical Devices
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FDA Issues Final Guidance on eCopy Program
Dear Medical Device Establishments,
Today the FDA issued final guidance on eCopy submissions, which describes our eCopy program, provides the technical standards for producing a valid eCopy, and notes the types of submissions for which an eCopy must be included:
Beginning Jan. 1, 2013, the FDA will only place a pre-market submission under review if it has an eCopy that has been validated by FDA’s eCopy loading system. Therefore, it is critical that you carefully review today’s guidance, particularly Attachment 1, which includes the technical standards.
Today's final guidance addresses the concerns and comments that the FDA received on the draft guidance as well as feedback received during informal discussions with industry. Although the basic requirements for eCopies did not change from the draft guidance, the document was reformatted to clarify points of confusion and be easier to follow.
Regulatory questions regarding the eCopy program should be directed to:
For more information about FDA’s implementation of MDUFA III, please see
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/MDUFAIII/default.htm.
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/MDUFAIII/default.htm.
Sincerely,
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