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Updated eCopy Guidance Clarifies FDA’s Electronic Submission Program

According to an updated guidance on FDA’s eCopy submission program, it now accepts a broader range of PDFs. The update contains expanded guidelines for industry when submitting electronic versions of applications to FDA.

FDA updated guidance on its eCopy program for medical device submissions Oct. 10 to clarify its proper usage to help companies submit electronic versions of device applications to the agency.

The revised guidance contains some substantive changes and adds clarifications and additional instructions to the previous final guidance issued on Dec. 31, 2012. (See Also see "FDA Finalizes 510(k), PMA, eCopy Guidances" - Medtech Insight, 7 January, 2013.

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