Dive Brief:

• FDA has updated the guidance on its electronic copy (eCopy) program shortly after moving to the fully electronic medical device premarket application process. 

• The latest version of the guidance, which FDA issued Monday, is almost identical to the document posted by the agency alongside an eCopy final rule late last year. 

• FDA tweaked its position on emergency use authorizations (EUA) but otherwise limited itself to formatting changes.

Dive Insight:

FDA gained the power to require eCopies of medical device filings through the Food and Drug Administration Safety and Innovation Act (FDASIA) of 2012. Since then, the agency has gradually moved to an electronic system, posting guidance in 2013 and going on to update its advice two years later.

The big shift came late last year when FDA published a final rule to remove paper from the process and stop the submission of multiple copies. In place of those outgoing filing requirements, FDA mandated single electronic submissions. FDA estimated the change will produce $1.8 million in annualized benefits over the coming decade.

With the rule having now come into effect, FDA has returned to the guidance it issued late last year to make some small changes. 

In its prior guidance, FDA stated applicants seeking an EUA could either file one eCopy or one complete paper copy, reflecting the fact that the fully electronic program is voluntary for companies seeking emergency use authorization. The revised guidance permits EUA applicants to file a copy via email, as well as by using the two previously disclosed methods. FDA pointed people interested in seeking EUA via email to its emergency use guidance for further details.

The revision sets the EUA pathway apart from all other medtech filings. While the use of eCopy is voluntary for certain other types of filing, such as compassionate use submissions, that flexibility only permits applicants to file paper copies as an alternative to electronic submissions. Only EUA filings can be shared via email. 

In the rest of the guidance, which is unchanged from the December version, FDA describes the processing steps for eCopies, walking applicants through the technical standards, timeframes and other factors relevant to the submission process.