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www.fdanews.com/articles/152299-final-guidance-clarifies-ecopy-policy-most-submissions-now-mandatory

Final Guidance Clarifies eCopy Policy, Most Submissions Now Mandatory

January 11, 2013
Compact discs attached to paper applications and including only limited data, such as large tables, won’t be accepted under the FDA’s new eCopy submission program, a final guidance states. All CDs must be valid eCopies. The guidance, which took effect Jan. 1, finalizes a draft released in October and requires eCopy submission for most types of device applications. The new program was mandated in the Food and Drug Administration Safety and Innovation Act that was passed last summer.
Devices & Diagnostics Letter