This month the FDA proposed a new rule to remove the requirements for medical device premarket submissions to be made on paper with multiple copies and replace them with a requirement for a single submission in electronic format (known as an eCopy). As a bit of background, before the technological and cultural shifts brought about by the widespread use of computers and the internet, all submissions to any center of the agency were made on paper, and multiple copies were required to facilitate review and storage. The Food and Drug Administration Safety and Innovation Act was passed in 2012, and this amendment to the FD&C Act allowed the agency to first issue a guidance on the submission of eCopies and subsequently require medical device submissions to include eCopies. The latest version of the guidance requires submission of one copy as paper and the remainder of the copies required by the regulations as eCopies. Fortunately, the FDA Reauthorization Act of 2017 changed the law to require medical device submissions occur in electronic format only.

This brings us back to the proposed rule, which includes:

Removing the requirements for multiple copies in device submissions and replacing them with a requirement for a single electronic version. Multiple copies are not required because the electronic version can be copied as needed.

Amending the regulations to remove the mailing addresses for submissions and replace those addresses with a website address for the Center for Devices and Radiological Health (CDRH) and CBER. These mailing addresses are currently hard-coded into the regulations, requiring an amendment to update the regulations when they change. The website will provide a list of the mailing addresses and can be updated when changes occur without an amendment to the regulations.

This rule will apply to premarket notification submissions (510(k) submissions), investigational device exemption (IDE) applications, premarket approval applications (PMA, including PMA supplements), humanitarian device exemption applications, and submissions for Center for Biologics Evaluation and Research (CBER) regulated devices. The purpose of the rule is the reduce the costs for submitters and improve the efficiency of the review process through instant availability of submissions as an eCopy.

The agency notes that an eCopy is different than an eSubmission, although both are considered electronic submissions. The difference is eCopies must still be mailed to the FDA, while eSubmissions may be transmitted over the internet. The plan is to transform all regulatory submissions from mailed copies to internet transmission, obviously still a work in progress. However, you may still use the eSubmitter-eCopies tool to ensure you meet all the submission requirements and facilitate packaging of your electronic device submissions (see my earlier post on this tool here). Submit your comments on this proposed rule to Docket FDA-2018-N-0628 by December 12, 2018.

Text Copyright © 2018 Katrina Rogers