FDA Goes Paperless for Device Submissions

Dump the paperwork!

On Friday, December 13, 2019, the FDA issued a final rule to allow medical device submissions to be made to the agency in a single electronic form instead of multiple paper copy submissions.

The new rules cover both the Center for Devices and Radiological Health (CDRH) and Center for Biologics Evaluation and Research (CBER) regulated devices. The agency said the new rule was in response to the Trump Administration’s “one-in, two-out” executive order.

For premarket approval applications (PMAs), the rule change removes a requirement to submit three copies of any updated safety and effectiveness report for pending applications. The agency previously required that PMAs be submitted in six copies, each bound in one or more numbered volumes.

“The requirement for a single submission in electronic format applies to all submission types that fall within the provisions listed in section 745A(b) of the FD&C Act; under this final rule, FDA is only amending those regulations that specifically mention paper and/or multiple copies of such regulatory submissions and are not consistent with this final rule,” stated the agency.

Submissions in electronic format include eCopies, submissions created and submitted on CD, DVD, or flash drive and mailed to FDA, and eSubmissions, submission package produced by an electronic submission template.

The new rule also removes the requirement that a PMA applicant has to provide copies of information that it believes to be trade secret or confidential commercial or financial information in the PMA.

The agency estimated the rule will result in annualized benefits of $1.76 million to the public.

To read the entire 24-page rule, click here.