FDA New eCOPY for Medical Device Submissions

FDA issued “eCopy Program for Medical Device Submissions” guidance dated Dec. 3, 2015. This document is at the link provided and replaced the prior version dated Oct 10, 2013. Electronic copies are required for many types of submissions to FDA. Section 6 Table 1 indicates which submissions require ecopies and how many and which are voluntary. Attachment 1 provides technical standards for ecopies and they are organized PDFs and FDA encourages use of bookmarks and hyperlinks.

FDA and 62304 Training – Boston – June 4-6, 2019

3-day course is designed to gain an understanding of how 62304 and other standards can be implemented efficiently and effectively while meeting FDA expectations as well.  John F. Murray, Jr., will be among the faculty!
The discounted April registration expires on April 30, 2019, or when all discounted seats are sold.

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