FDA Clarifies Standards for eCopy Medical Device Submissions

The FDA has issued new guidance clarifying the processing and technical standards for electronic copies for medical device submissions, based on the agency’s experience so far with the program.

The guidance, released last week, replaces an Oct. 10, 2013, version. The new version focuses on ways to help improve the efficiency of the review process.

In the new guidance, the FDA recommends that bookmarks and hyperlinks within a single PDF file be used to assist reviewers in navigating through the content of a submission. Also, the agency prefers creating a PDF file from the source document to create automatic searchable text.

In addition, the previous version of the guidance contained a sentence stating that “The size of the submission is irrelevant.” However, that sentence was removed in the new guidance. Instead, it says, “Although there is no maximum total submission size restriction, it is recommended that the total package submission not exceed 1 GB to avoid possible load time failures that may delay the submission process.”

The FDA originally released guidance on eCopies in December 2012. The Food and Drug Administration Safety and Innovation Act requires companies to submit an eCopy, in the form of a CD, DVD or flash drive, along with a paper submission.

eCopies are still required for a variety of submission types, including premarket notification submissions, premarket approval applications, product development protocols, investigational device exemptions, humanitarian device exemptions and emergency use authorizations, according to the new guidance.

Read the guidance on eCopy Program for Medical Device Submissions here: www.fdanews.com/12-15-FDA-eCopy.pdf. — Jonathon Shacat